2018 AZOA Bronstein Contact Lens & Cornea Seminar Handouts - (Dr. Thomas Quinn Lecture Notes)

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2018 AZOA Bronstein
   Contact Lens &
  Cornea Seminar
     Handouts
(Dr. Thomas Quinn Lecture Notes)
12/27/2017

                                                              Disclosures

                                                               Alcon

  Practical Problem-Solving                                    Allergan

          of Red Eye                                           Bausch   & Lomb
             in the Contact Lens Patient                       BioScience   Communications
              Thomas G. Quinn, OD, MS                          CooperVision
                     Athens, OH                                GPLI
                tgquinn5@gmail.com
                                                               STAPLES     Program
                                                               JJ   VC Vistakon

Red = Inflammation                                            Red = Inflammation

 Rubor    (redness)                                          A   protective response
 Tumor     (swelling)
 Calore    (heat)
 Dolore    (pain)

                             Courtesy of Bart Pemberton, OD

Red = Inflammation                                            Red Eye:Potential Causes

A     protective response                                             Contact   lens wear
 If   persists, can contribute to disease                             Non-CL    related conjunctivitis
                                                                        o Bacterial
A     red flag that something is amiss!
                                                                        o Viral
                                                                        o Allergic
                                                                       Dryness

                                                                       Other   irritants
                                                                        o Smoke
                                                                        o Dust
                                                                        o Pool Chlorine

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                                                                               First Step: A Good History

                                                                                        While modern medical technology has
                                                                                         greatly enhanced our ability to diagnose
                                                                                         and treat disease, it has also promoted
                                                                                         laziness—especially mental laziness—
                                                                                         among many physicians. Habitual reliance
                                                                                         on sophisticated medical gadgetry for
                                                                                         diagnosis prevents physicians from using
                                                                                         the most sophisticated, intricate machine
                                                                                         they'll ever and always have—the brain.
                                                                                                                  Herbert L. Fred, MD
                                                                                                             Professor, Department of Internal Med.
                                                                                                                     The University of Texas

 A Good History                                                                A Good History

                                                                                            Most valuable tools?                  Res. Physn
            442     consecutive patients
                                                                                             o   History alone                     19.8     19.3%
            Compared          experience: Correct Dx                                        o   Physical examination alone         0.8       0.5%
               o Senior Resident                       80.1%                                 o   Basic tests (BT) alone             1.1      1.3%
                   • (4 yrs)                                                                 o   Hx + Physical examination         39.5      38.6%
               o Experienced Clinician                 84.4%                                 o   Hx + BT                           14.7     14.7%
                   • (>20 yrs)                                                               o   Hx + Physical exam +BT            16.9     18.5%
                                                                                             o   Imaging studies                    6.5       6.1%

Paley L, et al. Utility of Clinical Examination in the Diagnosis of           Paley L, et al. Utility of Clinical Examination in the Diagnosis of
Emergency Department Patients Admitted to the Department                      Emergency Department Patients Admitted to the Department
of Medicine of an Academic Hospital Arch Intern Med. 2011;171(15):1393-1400   of Medicine of an Academic Hospital Arch Intern Med. 2011;171(15):1393-1400

 HPI                                                                           Location

                                                                                Where’s         the red?
                                                                                   o One or both eyes?
                                                                                   o Overall?
                                                                                   o Paralimbal?

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“My eye is red”                              “My eye is red”

                                                                     •   22 year old college student
                                                                     •   SCL wearer/DW/Reusable
                                                                     •   MPS
                                                                     •   corneal infiltrates OD

“My eye is red”                              “My eye is red”

 OS:                                         What   we did…
  o minimal injection                          o Switched her to Hydrogen Peroxide-based
  o 1+ infiltrates superior cornea               care system
                                               o Asked to return in 2 weeks

             What To Do?

“My eye is red”                              Location

                                              Where’s   the red?
                                               o One or both eyes?
                                               o Paralimbal?
                                               o Sectoral?
                                               o Overall?
                                               o In the aperture? Dryness
                                               o At the eyelid margin? Blepharitis/MGD

        Before                       After

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                              [ 19 ]                                       [ 20 ]

MGD Treatment                          HPI
 Hot   compresses
  o MGDRx heat mask
 Hygiene
  o Foaming eyelid cleanser
  o Avenova
 Medications
  o Topical
  o Oral
     • Doxycycline
     • Azithromycin

Quality                                Quality: Itch

 How   do your eyes feel?              Where?
                                         o Both eyes? Allergy
  o Itch        Allergy?                 o Nasal canthus? Allergy
                                         o Eyelid margins? Blepharitis
  o Burn        Dryness?

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 Quality: Itch                                      Quality: Burn

  Where?                                            Where?
    o Both eyes? Allergy                              o Both eyes? Dryness
    o Nasal canthus? Allergy                          o One eye? Host of possibilities
    o Eyelid margins? Blepharitis                    When?
  When?                                              o After reading/computer use? Dryness
    o Seasonal? Allergy                               o After CL application? Soln/Hands?/Lotion
    o After computer use? Dryness                    Modifying   factors?
  Modifying   factors?                               o Rubbing? Dryness: helps comfort and vision
                                 Worse  Allergy
    o Rubbing? Does it help?
                                 Better  Dryness

 HPI                                                Associated symptoms

                                                     Produce   matter?
                                                      o Stringy vs globular Allergy vs Infection
                                                      o White vs green Allergy vs Infection
                                                      o Matted shut in am? Conj or Bleph?/ RCE?
                                                     Watery?     Viral? Dryness?
                                                     Photophobia? Uveitis/Cornea?

 Red Eye: Potential Causes                          HPI

        Contact    lens wear
  Treat  Non-CL    related conjunctivitis
          o Bacterial
          o Viral
          o Allergic
  Treat  Dryness
Remove  Other   irritants
          o Smoke
          o Dust
          o Pool Chlorine

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Is redness associated with CL wear?                                                      Is redness associated with CL wear?

 Modifying        factors (What helps?)                                                 Dosymptoms get worse when you wear your
    o Removing CL’s!!!                                                                   CL’s?
                                                                                         Dosymptoms get better when you remove
                                                                                         your CL’s?
                                                                                         Do   you wake up with red eyes?
                                                                                          o DW?
                                                                                          o EW?

Causes of CL Red Eye                                                                     The Quest for Safety

 Hypoxia                                                                                 Oxygen!

                                                                                          Enter      Silicone Hydrogels
                                                                                               o 67% of US market

                                                                                                                                J Nichols, CL Spectrum, Jan 2017

Benefits of Silicone Hydrogels                                                           Benefits of Silicone Hydrogels
   Fewer hypoxic changes                                                                   Fewer hypoxic changes
    o Less limbal redness                                                                      o Less limbal redness
       • 31% (EW) - 35% (DW) with                                                              o Less neovascularization
         hydrogels2                                                                               • 18% with hydrogel EW

                                       Papas EB, Vajdic CM, Austen R, Holden
                                       BA: High oxygen transmissibility soft
                                       contact lenses do not induce limbal                                                 Dumbleton KA, Chalmers RL, Richter DB,
                                       hyperaemia. Curr Eye Res 1997; 16:                                                  Fonn D. Vascular response to extended
                                       942-948,                                                                            wear of hydrogel lenses with high and
                                                                                                                           low oxygen permeability.
     2. Chalmers RL, Dillehay S, Long B, et al. Impact of previous extended and                                             Optom Vis Sci 2001, 78(3): 147-151.
     daily wear schedules on signs and symptoms with high Dk lotrafilcon A
     lenses. Optom Vis Sci. 2005;82:549-554.

                                                                               [ 35 ]                                                                              [ 36 ]

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Benefits of Silicone Hydrogels                                                            Benefits of Silicone Hydrogels
   Fewer hypoxic changes                                                                     Fewer hypoxic changes
    o Less limbal redness                                                                      o   Less limbal redness
    o Less neovascularization                                                                  o   Less neovascularization
    o Fewer corneal microcysts                                                                 o   Fewer corneal microcysts
       • 90-100% in hydrogel EW                                                                o   Less myopic creep
                                                                                                    • 49% of EW Hyd wearers

     Low Dk lens wearers switched
           to high Dk lens
                                                                                                                              Dumbleton KA, Chalmers RL, Richter DB,
            High Dk lens wearers                                                                                              Fonn D. Changes in myopic refractive error
                                                                                                                              with nine months` extended wear of
                                              Keay L, Sweeney D, Jalbert, I et al,                                            hydrogel lenses with high and low oxygen
                                              Microcyst Response to High Dk/t                                                 permeability. Optom Vis Sci 1999;76:845-9 .
                                              Silicone Hydrogel Contact Lenses,
                                              Optom Vis Sci 2000; 77(11):582-585.

                                                                                 [ 37 ]                                                                                  [ 38 ]

Silicone Hydrogels                                                                        Silicone Hydrogels
However:
                                                                                              MK rates unchanged (~5xDW)
                                        1. Poggio EC, Glynn RJ, Schein OD, et al
   MK rates unchanged with EW          The incidence of ulcerative keratitis                 Mechanical issues
    (~5xDW)                              among users of daily-wear and                         o Patient comfort/adaptation
    o  19891(Hyd): 20.9/10,000          extended-wear soft contact lenses                      o Contact lens-induced papillary
                                        N Engl J Med 1989 Sep 21; 321(12) :779-83.               conjunctivitis (CLPC)
    o 20052 (SiHy): 18.0/10,000
          3
    o 2008 (SiHy): 25.4/10,000                                                                    • Higher rate of local CLPC
                                                                                                     with SiHy lenses (4.6%)
                                    2. Schein OD, McNally JJ, Katz J et al. The
                                    Incidence of microbial keratitis among wearers                • DD SiHy: rate significantly
                                    of a 30-day silicone hydrogel extended-wear                      reduced
                                    contact lens. Ophthalmology 2005 Dec; 112(12):
                                    2172-9
                                                                                          Skotnitsky C, et al. The incidence of local and general contact lens induced
                                                                                          papillary conjunctivitis in silicone hydrogel contact lenses.
                   3. Stapleton F et al. The incidence of contact lens-related            Invest Ophthalmol Vis Sci 2005 46: E-Abstract 2064.
                   Microbial keratitis in Australia. Opththalmology 2008 Oct;
                   115(10):1655-62.

                                                                                 [ 39 ]                                                                                  [ 40 ]

Causes of CL Red Eye                                                                      GPC (CLPC)
                                                                                              Symptoms:
 Hypoxia                                                                                       o Itchy/ mucous
                                                                                                o Len decentration/
 Mechanical/Allergic                                                                             intolerance

                                                                                              Onset:
                                                                                                o Variable/ allergy season?

                                                                                              Treatment:
                                                                                                o D/C CL wear
                                                                                                o Steroids/antihistimine/
                                                                                                  mast cell stablizer
                                                                                                o Refit  DD

                                                                                                                                                                                  7
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                                                                Scleral Blanching

A   (Lid) Flip Should Be Part of Every CL Exam!

                  Gabby Douglas, US Olympian

Causes of CL Red Eye                                            Silicone Hydrogels

 Hypoxia                                                          MK rates unchanged (~5xDW)
                                                                   Mechanical concerns
 Mechanical/Allergic                                              Concern about corneal
                                                                    inflammatory events (CIEs)
 Corneal    Infection/ Inflammation                                 o 26.7% incidence1
                                                                     o 2x increase vs hydrogel 1,2

                                                               1. Szczotka-Flynn L, Diaz M, Risk of corneal inflammatory events with silicone
                                                                  hydrogel and low Dk hydrogel extended contact lens wear: A meta-analysis
                                                                  Optom & Vis Sci April 2007;84(4):247-256

                                                               2. Radford CF, et al.Risk factors for nonulcerative contact lens complications in
                                                                  an ophthalmic accident and emergency department: a case-control study.
                                                                  Ophthalmology 2009 Mar;116(3):385-92.
                                                                                                                                                      [ 46 ]

CLARE     (Contact Lens Associated Red Eye)                     CLPU (Contact Lens Peripheral Ulcer)

 Symptoms                                                       Symptoms
  o Watery, painful eye                                             o mild-moderate redness/ discomfort/ tearing
                                                                         • 50% asymptomatic
 Onset                                                                      – Bandage CL effect?

  o On waking with EW                                            Etiology
 Etiology                                                          o Gram positive bacteria
  o Gram neg bacteria                                                 exotoxins (staph)

 Treatment                                                      Treatment
                                                                                                              (Courtesy: CCLRU/LVPEI Guide to
  o D/C CL Wear;Meds?               1. Fonn, D and Sivak, A.        o D/C CL Wear;Meds?                          Corneal Infiltrative Conditions)

  o 1/3 will recur1                 CL Spectrum, Feb 2005.          o Lid hygiene

                                                                                                                                                               8
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                    Sterile vs Infectious                                                               Silicone Hydrogels
                                                                                                           MK rates unchanged (~5xDW)
                                                                                                           Mechanical concerns
                                                                                                           Concern about corneal
                                                                                                            inflammatory events (CIEs)
                                                                                                             o 26.7% incidence1
                                                                                                             o 2x increase vs hydrogel 1,2
                                                                                                                • Material/wear sch/other?

                                                                                                       1. Szczotka-Flynn L, Diaz M, Risk of corneal inflammatory events with silicone
                                                                                                          hydrogel and low Dk hydrogel extended contact lens wear: A meta-analysis
                                                                                                          Optom & Vis Sci April 2007;84(4):247-256

                                                                                                       2. Radford CF, et al.Risk factors for nonulcerative contact lens complications in
                                                                                                          an ophthalmic accident and emergency department: a case-control study.
                                                                                                          Ophthalmology 2009 Mar;116(3):385-92.
                                                                                                                                                                                                [ 50 ]

What about mucin balls?                                                                                 Risk factors for adverse events
   Early mucin balls                                                                                      Age
     o suggests greater                                                                                      – Greatest risk: late adolescence and early adulthood
       propensity to CIEs
                                                                                                           Years of contact lens wear
   Late mucin balls
                                                                                                           Silicone hydrogel material
     o suggests protective
                                                                                                             – Unreported overnight wear?
                                                                                                                                                           Carnt N, et al., Contact lens-related
                                                                                                             – Higher lens modulus?                        adverse events and the silicone
                                                                                                             – Care system issues?                         hydrogel lenses and daily wear
                                                        Photo from Lakshman N. Subbaraman                                                                  care system used, Arch. Opthal,
                                                                                                           Lens replacement schedule                      127(12):1616-1623.
                                                                                                             – Other than daily disposable

      Loretta B. Szczotka-Flynn et al. Mucin Balls Influence Corneal Infiltrative Events,
      Optometry and Vision Science , April 2017                                                        Wagner H, et al (CLAY Group), Risk factors for interruption to soft contact
                                                                                                       lens wear in children and young adults, Optom Vis Sci, Aug 2011;88(8):973-980.

                                                                                              [ 51 ]                                                                                            [ 52 ]

Risk factors for CIE’s                                                                                  Contact Lens Safety
   Bacteria bind in higher levels to SiHy lenses                                                          Incidence of CIEs:
     – Related to increase in CIEs?                                                                               • DD vs Reusable:
                                                                                                                     – 12.5 X less likely
                                                                                                                       with DD1
                                                                                                                  • DD SiHy vs DD Hyd:
                                                                                                                     – SiHy DD: 0.4%
                                                                                                                     – Hyd DD: 0%
                                                                     Pseudomonas aeruginosa
                                                                     Source: CDC                             1.Chalmers, Robin L. et al, Multicenter Case-Control Study of the Role of Lens
    Subbaraman LN, et al. Influence of                                                                       Materials and Care Products on the Development of Corneal Infiltrates,
    protein deposition on bacterial                                                                          Optometry & Vision Science. 89(3):316-325, March 2012.
    adhesion to contact lenses.
                                                                                                             2. Chalmers RL et al, Rates of Adverse Events With Hydrogel and Silicone
    Optom Vis Sci Aug 2011;88(8):959-966                                                                     Hydrogel Daily Disposable Lenses in a Large Post Market Surveillance Registry:
                                                                                                             The TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63

                                                                                              [ 53 ]                                                                                            [ 54 ]

                                                                                                                                                                                                         9
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  Take-Aways
      Detailed History: is a powerful tool: give time to it
      Where’s the red?
      Itch doesn’t necessarily mean allergy (though it might!)
      Burn doesn’t necessarily mean dryness (it might!)
      Key Indicators that CL’s are contributory to redness:
       – Improvement with contact lens removal
       – Worsening with contact lens application
      Likely Contact Lens Culprits:
       – Hypoxia (especially with extended wear and high Rx)
       – Mechanical/ Allergic
       – Infection/ Inflammation
      Clean Lenses and Clean Hands!

                             Illegal CL Sales                                                Illegal CL Sales
   • Contact lenses are being sold without an Rx                  • WatchDog Work*
     or with an expired Rx                                          – recorded 102 websites selling CLs illegally
      – In the decorative CL segment*:                               – stopillegalCLs@aoa.org
            • 2013: 24% purchased without an Rx
                                                                         • 51 separate reports of illegal CL sales
            • 2014: 53% purchased without an Rx
                                                                              – 19 physical stores
            • 2015: 26% purchased without an Rx                               – 32 websites
   • stopillegalCLs@aoa.org           to:                                • 13 adverse events from wear of illegally purchased CLs
      – Report suspected illegal sales                            • Next Steps
      – Report adverse events from illegal CLs                       – Develop WatchDog network in each state
   • AOA reports illegal sales to appropriate authority
* American Optometric Association’s
 American Eye-Q® consumer survey                                   * As of April 2016

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                                                            Disclosures
                                                            •   Alcon
Medical Management of the                                   •   Allergan
                                                            •   Bausch & Lomb
Presbyopic Patient                                          •   BioScience Communications
Thomas G. Quinn, OD, MS                                     •   CooperVision
Athens, OH                                                  •   GPLI
tgquinn5@gmail.com                                          •   STAPLES Program
                                                            •   JJ VC Vistakon

                                                                            Cornea

                                                                      Contact    Crystalline
Who are we talking about?                                              Lens         Lens

Gen Xers (45-54 yo)               Baby Boomers (55-64 yo)
•   Tech savy                     • Desire to stay active
•   High level of activity          ▫ Socially
•   Adaptable                       ▫ Intellectually
•   Value freedom                   ▫ Physically

    Intraocular Implants (IOLs)
    Scleral Expansion
    Eye drops?

                                                                                                       1
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Refractive Lens Exchange
• Replacement of CLEAR crystalline lens with an
  IOL

• Potential Complications:
         Corneal decompensation
         Cystoid macular edema
         Retinal detachment
           Myopes: 1-8%* vs 0.68% (>-10.00)

• Employed with high hyperopia (>+3.00 D)
  ▫ LASIK and other refractive techniques not viable
  ▫ Narrow angles

                                 *Jorge L et al, Surv Opthal, Nov-Dec 2014

IOLs                                                                         Monofocal IOL-Monovision
                                                                                    •Distance eye set for plano
• Generally reserved for those with visually                                        • Near eye set for -1.25
  significant cataracts
                                                                             Advantages                                 Challenges
                                                                             • Can work well                            • If no prior experience:
• Options:                                                                     ▫ Particularly with those who               ▫ can be difficult to assess
  ▫ Monofocal set to monovision                                                  have successfully worn                      anticipated response in
  ▫ Multifocal                                                                   monovision CL                               presence of a cataract

  ▫ Accommodative

Multifocal IOL                                                               Multifocal IOLs
     •Refractive- bending of a wave when it enters a
                                                                             Diffractive Optics
     medium where its speed is different
                                                                             • Step height                              • Apodization
     • Diffractive- bending and spreading of a wave as
                                                                                        The higher the step height,            the gradual shortening of
     a result of passing through a narrow aperture or                                   the more light is distributed          step heights toward the
     across an edge                                                                     to near focal point                    periphery of the diffractive
                                                                             • Distance between steps                          zone.
                                                                                        determines the add power
                                                                                        of the lens

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                                                                                                 J&J
ReSTOR MF IOL (Alcon)                                                            Tecnis MF IOL (Abbott)
• 2 designs                                                                      • 3 designs
• Diffractive optics on anterior surface                                         • Diffractive optics on posterior surface

Monovision IOL vs Multifocal IOL                                                 Monovision IOL vs Multifocal IOL
• 212 patients                                                                   • Results:
• Randomly assigned preoperatively                                                 ▫ Monovision IOL patients more than 7x more likely to need glasses at
  ▫ Monofocal aspheric IOL                                                           least some of the time
       Near eye target: -1.25 D (actual: -0.92D)                                   ▫ Total spectacle independence
  ▫ 3-piece multifocal IOL                                                               26% of monovision IOL subjects
       Tecnis ZMB00 +4.00(AMO)                                                           71% of multifocal IOL subjects
• Assessed at 4 months post-op                                                     ▫ Binocular Unaided Acuity
                                                                                         Distance: similar
                                                                                         Intermediate: best with monovision
                                                                                         Near: best with multifocal

               Wilkins MR, Allan BD, Rubin GS, et al. Randomized Trial of                       Wilkins MR, Allan BD, Rubin GS, et al. Randomized Trial of
               Multifocal Intraocular Lenses Versus Monovision After Bilateral                  Multifocal Intraocular Lenses Versus Monovision After Bilateral
               Cataract Surgery. Ophthalmology. 2013;120:2449-2455                              Cataract Surgery. Ophthalmology. 2013;120:2449-2455

Monovision IOL vs Multifocal IOL                                                 Glare with Multifocal IOL
                                                                                 • Causes of Glare:
• Results:                                                                         ▫   Posterior capsule opacification (66%)
  ▫ Glare/Halos
                                                                                   ▫   IOL decentration (12%)
       18% of monovision IOL patients
                                                                                   ▫   Retained lens fragment (6%)
       43% of multifocal IOL patients
                                                                                   ▫   Dry eye (2%)

                                                                                 • Causes of Blur:
                                                                                   ▫   Posterior capsule opacification (54%)
                                                                                   ▫   Ametropia (29%)
                                                                                   ▫   Dry eyes (15%)
               Wilkins MR, Allan BD, Rubin GS, et al. Randomized Trial of          ▫   Unexplained (11%)
               Multifocal Intraocular Lenses Versus Monovision After Bilateral
                                                                                                Woodward MA, Randleman JB, Stulting RD, Dissatisfaction after
               Cataract Surgery. Ophthalmology. 2013;120:2449-2455
                                                                                                multifocal intraocular lens implantation. J Cat & Ref Surg. 35(6):992-
                                                                                                997, June 2009.

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Stretching the optics…                                    Accommodative IOL
 • Tecnis Symfony MF IOL (Abbott/J&J)                     • Powered by action of the ciliary muscle
   ▫ Extended depth of focus optics                        ▫ Haptics are placed in the capsular bag
      modification of the height and the profile of the
      diffractive optics
      Unique wavefront-designed aspheric surfaces
        Reduced spherical aberrations
        reduced chromatic aberration
      Effective add around 1.50 D

Accommodative IOL                                         Accommodative IOL
                                                          • Powered by action of the ciliary muscle
                                                          • Creates 1.00-1.50 D of add
                                                           ▫ Crystalens (Bausch + Lomb)
                                                           ▫ Trulign toric IOL (Bausch + Lomb)
                                                               “broader range of vision” lens
                                                               1.25-2.75 DC

What about astigmatism?                                   On the MF IOL Horizon…
                                                          • Mechanical accommodating IOLs
• Corneal relaxing incisions                                ▫ Acrylic optic
  ▫ 1 to 3 D of corneal astigmatism (0.50D/3 mm)                Tetraflex IOL(Lenstec) acrylic optic
                                                                Tek-Clear IOL (Tekia)
• Trulign toric IOL (Bausch + Lomb)                             Lumina IOL(Akkolens)
  ▫ May 2013                                                      designed for placement in the sulcus
                                                                  may be less affected by fibrosis than placement in the
  ▫ 1.25 to 2.75 DC                                               capsular bag
• Tecnis Symfony MF IOL (Abbott/J&J)                        ▫ Fluid lens
  ▫ July 2016                                                   FluidVision IOL (PowerVision)
  ▫ 1.00 to 6.00 DC                                               3-4 D of accommodation reported
• Acrysof IQ ReSTOR Toric MF IOL (Alcon)                    ▫ Silicone gel lens
  ▫ December 2016                                               NuLens IOL (NuLens Ltd.)
                                                                  “designed to provide up to 10 D of accommodation”
  ▫ 1.50 to 6.00 DC

                                                                                                                                   4
12/27/2017

On the MF IOL Horizon…
Comparison of the Visual Outcomes after Cataract Surgery with
Implantation of a Bifocal and Trifocal Diffractive Intraocular Lens                   • https://www.fda.gov/NewsEvents/Newsroom/P
Sung Yu, MD, et al, Clin Ophthalmol, Mar 2016.
                                                                                        ressAnnouncements/ucm586405.htm
• To evaluate and compare visual outcomes and optical quality after implantation of
  a bifocal (Acrysof ReSTOR® SN6AD1) or trifocal (AT LISA® tri 839MP) diffractive
  intraocular lens (IOL).                                                             • FDA approves first implanted lens that can be
• Conclusions: Trifocal diffractive IOLs provide significantly better                   adjusted after cataract surgery to improve
  intermediate vision than bifocal IOLs, with equivalent postoperative levels           vision without eyeglasses in some patients
  of distant and near vision and ocular optical quality.

On the MF IOL Horizon…                                                                Pharmacological Treatments
                                                                                      • Most have used Parasympathomimetics
• THE STALLED                                                                            (in combination with other agents):
  Sapphire Autofocal (Elenza, Inc.)                                                          Miosispinhole effectincreased depth of focus

   ▫ first “electro-active” accommodating IOL                                         • Results (all pilot studies):
                                                                                        ▫ Improvement in near vision for 5-10 hours, then fades
   ▫ Accommodation occurs by means of a liquid                                          ▫ Some side effects
     crystal optic that changes power in response to                                        Burning/stinging
                                                                                            Conjunctival injection
     an electronic signal                                                                   Dull headache
                                                                                            Nausea
   ▫ The lens contains a rechargeable battery and                                           Dimming of vision
     changes focus based on physiological triggers
                                                                                      Pharmacological treatments of presbyopia: a review of modern perspectives
                                                                                      Antonio Renna,Jorge L. Alió and Luis Felipe Vejarano, Eye and Vision,
                                                                                      Published: 7 February 2017

Pharmacological Treatments                                                            Pharmacological Treatments
• Pilocarpine                                                                         • EV06 (Encore Vision Novartis in Dec 2016)
   ▫ Creates pinhole effect (goal: consistent 1.6 mm)                                   ▫ Lipoic Acid Choline Ester 1.5%
   ▫ US Patent Application 20150174105                                                          A prodrug that penetrates cornea
        2% Pilo diluted to 1% Pilo with Balance Salt Soln                                       ▫ Lipoic acid- enzymes in lens fiber cells reduce it to
        Combined with bromfenac                                                                   dihydrolipoic acidreduces disulphide bondsimproved
           ▫ to reduce potential inflammation                                                     flexibility

   ▫ Derek Cunningham, OD
         effect lasts 8 hours
         anticipate approval in 1-2 years

                                                                                                                                                                      5
12/27/2017

                                                                                   Pharmacological Treatments
                                                                                   • EV06 –Phase I and II Trials (50-test/25-control)
                                                                                     ▫ B.i.d. dosing
                                                                                     ▫ Safety:
                                                                                         Well tolerated (comfort scores equivalent to control)
                                                                                         No loss in best corrected distance vision
                                                                                     ▫ Effectiveness:
                                                                                         Improvement in near vision noted as soon as 2 wks
                                                                                         At 90 days (statistically significant change vs control):
                                                                                           20/40 or better in 82%
                                                                                           20/32 or better in 60%
                                                                                           20/25 or better in 36%

Pharmacological Treatments
• EV06
       What is the durability of effect?
       Long-term safety?
                                                                                    Investigational procedure
       Might it help slow nuclear sclerotic cataracts?

Theories of Accommodation                                                          Scleral Expansion
• Helmholtz Theory                  • Schachar Theory                              • Tightening zonules by inserting “tissue barriers”
  ▫ Zonular tension is decreased      ▫ Zonular tension is increased with
    with ciliary body contraction       ciliary body contraction                     ▫ Titanium, silicone, PMMA
                                      ▫ stretching causes an increase in the
  ▫ Relaxation allows lens to           volume, curvature, and power of the
    expand                              central lens
  ▫ Lens age = lens hardening         ▫   Lens age = growth in equatorial
                                          diameter, forces become less effective
                                          due to increased zonular laxity

                                                                                                                                                             6
12/27/2017

Scleral Expansion                                                                    Scleral Expansion for Presbyopia
Benefits                                    Challenges                                • American Academy of Ophthalmology website
• May increase accommodative                • Very little evidence it actually
  function                                    has an effect!!                           ▫ “ Schachar’s theory…has not been supported by
• May reduce IOP
                                                                                          primate and human physiology studies.”
  ▫ increased baseline tension
    of the ciliary muscle
        leads to increase in                                                            ▫ “Clinical results with these approaches have
       trabecular meshwork pore
       size                                                                               been disappointing, leaving little support for the
                                                                                          Schachar theory or scleral expansion as an
                                                                                          effective means of presbyopia correction.”

Scleral Expansion for Presbyopia
 • University of Houston College of Optometry study
     • Subjective measures
     • Objective measures
                                                                                       • Shape modification
                                                                                          • Laser
 • Conclusion:                                                                            • Molding devices
                                                                                          • Radio energy (Conductive Keratoplasty)
   • “No increase in accommodative amplitude … Patient
     satisfaction may have come from the high expectations                             • Corneal Inlays
     this patient had for a positive surgery outcome.”

            Ostrin LA et al, Evaluation of a satisfied bilateral scleral expansion
            band patient. J Cataract Refract Surg. 2004 Jul;30(7):1445-53.

Presbyopic Corneal Shape Modification                                                Multifocal LASIK- 1 yr Post-Op
 • Laser Treatment (monovision or multifocal)                                        The Promising                                   The Concerning

   ▫ Strength                                                                          ▫ 20/20 distance acuity: 93%                    ▫ 7% lost two Snellen lines
                                                                                       ▫ J2 near acuity: 90%                           ▫ 19% retreatment rate
           Permanent
                                                                                                                                       ▫ 3% reversal rate
   ▫ Limitation
           Irreversible if outcomes less than desirable                                                   Currently investigational
   ▫ Outcomes?
                                                                                                     Luger MH et al. Presbyopic LASIK using hybrid bi-aspheric micro-
                                                                                                     monovision ablation profile for presbyopic corneal treatments.
                                                                                                     Am J Ophthalmol, 2015 Sep;160(3):493-505.

                                                                                                                                                                             7
12/27/2017

Presbyopic Corneal Shape Modification                                            Presbyopic Corneal Shape Modification
• Corneal Molding Devices (orthokeratology)                                      • 16 emmetropic presbyopes
  ▫ Strength                                                                     • Fit with hyperopic OK lenses
        Reversible if outcomes less than desirable                                 ▫ Induces central corneal steepening: myopia
  ▫ Limitation                                                                   • Results:
        Device must be applied each night                                          ▫ Approximately 1 to 1.50 D max of myopic shift
        Currently limited to monovision                                            ▫ Effect lasts longer after more days of wear
           Under-correct myopia in one eye
           Induce myopia in an emmetropic eye
                                                                                            Gifford P and Swarbrick HA, Refractive Changes from Hyperopic
  ▫ Outcomes?                                                                               Orthokeratology Monovision in Presbyopes. Optom & Vis Sci,
                                                                                            April 2013.

Presbyopic Corneal Shape Modification                                            Presbyopic Corneal Shape Modification
• IntraCor (B+L)                                                                 • Conductive Keratoplasty
  ▫ Investigational in USA                                                             Low-level radio frequency energy
        Approved in Europe                                                             April 2004: approved for temporary improvement of presbyopia
                                                                                       Performed on non-dominant eye of emmetrope
• Procedure:
  ▫   Femtosecond laser                                                            ▫ Strength
  ▫   Precisely placed gas bubbles                                                     Minimally invasive
  ▫   Reshapes interior of cornea                                                      Complications are rare
  ▫   Epithelium remains intact
                                                                                   ▫ Limitation
• Pros and Cons:                                                                       Must be emmetropic
  ▫ Safe! (no epi break)                                                               Cost: approx $2300/eye
  ▫ Halos (diminish with time)                                                         Results are temporary               Collagen shrinkage creates a
                                                                                                                               belt-tightening effect

Presbyopic Corneal Shape Modification
• Conductive Keratoplasty
        6 pts had CK after LASIK or PRK
        12 pts had CK without LASIK or PRK
                                                                                  Shape altering
• Results:                                                                        Refractive altering
        0.033 D regression/month= 0.396 D/year                                    Pinhole
           ▫ Approximately 2.5 yrs to lose 1 D
        Rate of regression similar in both groups
               Moshirfar M et al. Comparing the rate of regression after
               conductive keratoplasty with or without prior laser-assisted in
               situ keratomileusis or photorefractive keratectomy, Middle East
               Afr. J Ophthal. October 2012.

                                                                                                                                                              8
12/27/2017

Corneal Inlays- shape altering                       Raindrop Inlay (shape changing)
• Raindrop Near Vision Inlay (Revision Optics)       Strengths                          Challenges

     Approved June 2016                              • Significant improvement in        • Centration is vital
                                                       near and intermediate vision        ▫ Slippery decentration
     2.0 mm hydrogel disk (approx 80% H2O)
                                                     • Binocular function remains                20% per Whitman et al*
       ▫ Promotes nutrient movement through cornea
                                                       good (vs monovision)                      NO eye rubbing!
                                                     • Safety well established           • Slow steroid taper
                                                       ▫ Easily removable

                                                                                       * Whitman et al, Ophthalmology, 2016;
                                                                                         123:466-475.
                       Raindrop Near Vision Inlay

Corneal Inlays- Refractive altering                  Corneal Inlays- Pinhole effect
• High index inlay                                    • Kamra Corneal Inlay (AcuFocus)
  ▫ Presbia Flexivue
    Microlens Inlay (Presbia)                           ▫ Approved in U.S. April 2015
     0.15 mm center hole                                ▫ Implanted in non-dominant eye
       Nutrient flow
     1.6 mm plano zone
       Distance vision
     3.2 mm diam
       +1.25  +3.50
                                                                                                                   GP lens
                                                        Kamra Inlay
     Investigational in USA                          (1.6 mm aperture)
       Phase 2 trials
       Available in over 40
       countries

Corneal Inlays- Pinhole effect                       Kamra Corneal Inlay (pinhole effect)
                                                     Strengths                          Challenges
                                                     • Significant improvement in        • Distance vision reduced
                                                       near and intermediate vision        slightly
                                                     • Binocular function remains        • Night driving issues
                                                       good (vs monovision)                ▫ Reduced illumination
                                                     • Quick procedure                     ▫ glare
                                                       ▫ Approx 15 minutes               • Best dist Rx -0.50  -0.75
                                                       ▫ Can be performed in office      • Cost: $4000-5000 (one eye!)
                                                     • Quick recovery
                                                       ▫ 24-48 hrs to return to work
                                                     • Safety well established
                                                       ▫ Easily removable

                                                                                                                                       9
12/27/2017

                                                 Let Science Speak

MULTIFOCAL vs MONOVISION:
• MV vs Essential GP (Johnson, 2000)
  ▫ 75% preference for multifocal
• MV vs Acuvue Bifocal (Situ et al, 2003)
  ▫ 68% preference for multifocal
• MV vs Soflens MF (Richdale et al, 2006)
  ▫ 76% preference for multifocal
• MV vs Air Optix Aqua MF (Woods et al, 2015)
  ▫ 51% preference for multifocal                     “That’s not been my experience”
  ▫ 37% preference for monovision
  ▫ 12% didn’t like either

MULTIFOCAL vs MONOVISION:                       Restaurant Tools
  MV vs Acuvue Bifocal (Situ et al, 2003)       • Magnifiers
    68% preference for multifocal               • Light
    Issues with near vision in low light        • Apps
  MV vs Soflens MF (Richdale et al, 2006)
    76% preference for multifocal
    Issues with near vision in low light

                                                                                               10
12/27/2017

    What’s the best way to assess
    MF performance?
•    Woods, J, et al (2009)                                                                              What do we fit?
     ▫    Assessed both objective and subjective
          results/ratings                                                                                • The Decision Drivers
                  Objective testing (exam room)                                                              ▫ Astigmatic error
                        Monovision “best performer” for high- and low-contrast                                   Where’s the flinch level?
                        near vision tests
                  Subjective ratings (“real world”)
                        Monovision “lowest performer”
                        Multifocal contact lenses “highest performer” in areas
                        such as: Night driving, television, computer

          Woods, J, et al. “Early Symptomatic Presbyopes – What Correction Modality Works Best?” Eye &
                  Contact Lens 2009;5: 221 – 226.

     Sphere versus Toric
     • 30 eyes with 0.75- 2.00DC fit with spherical and
       toric lenses
               Acuvue Advance, Biomedics 55, Frequency 55, Softlens 66
     • Two groups:
         ▫ Less than or equal to 1.00 DC
         ▫ 1.25-2.00DC

     Richdale, Kathryn et al, Visual acuity with spherical and toric soft contact                        Richdale, Kathryn et al, Visual acuity with spherical and toric soft contact
     lenses in low-to moderate- astigmatic eyes, Optom and Vision Science,                               lenses in low-to moderate- astigmatic eyes, Optom and Vision Science,
     84(10):969-975, Oct 2007                                                                            84(10):969-975, Oct 2007

     The Astigmatic Component                                                                            Prevalence of 0.75 DC or greater
     • 0.75 DC is the “flinch level”                                                                     •   In at least one eye: 47.4%
                                                                                                         •   In both eyes: 24.1%
                                                                                                         •   Myopes vs Hyperopes: 31.7% vs 15.7%
                                                                                                         •   WTR vs ATR: 32.9% vs 29.1%
                                                                                                         •   Conclusion:
                                                                                                             ▫ “We estimate that approximately 1/3 of
                                                                                                               potential CL wearers require astigmatic
                                                                                                               correction           Young G et al, Prevalence of
                                                                                                                                              astigmatism in relation to soft contact
                                                                                                                                              lens fitting, Eye Contact Lens. Jan 2011

                                                                                                                                                                                               11
12/27/2017

Astigmatism and Age                                                              The Astigmatic Component
• Prevalence of astigmatism increases with                                       • 0.75 DC is the “flinch level”
  age1,2,3                                                                         ▫ Especially if:
• Amount of astigmatism increases with age3                                             Low spherical error
     ▫ 0.05D per decade                                                                 Dominant eye
• Axis changes from WTR to ATR2,3,4                                                     ATR axis
     ▫ Due to corneal shape changes                                              • Is it corneal astigmatism?

1.   Sanfillippo PG et al, Acta Ophthalmol, 2015 (Australia)
2.   Liu YC et al, Invest Ophthalmol Vis Sci, 2011 (China)
3.   Schuster AK et al, Graefe’s Arch Clin Exp Ophthalmol, 2017 (Germany)
4.   Leung TW et al, Optom Vis Sci, 2012 (Hong Kong)

Corneal Astigmatism ≠ Spectacle
Astigmatism
                                                                                 Multifocals for Astigmats
• Toric Soft Options                                                             • Soft Toric Multifocals
         Toric SV Soft Distance OU with readers
                                                                                   ▫   ASTERA multifocal toric (Alden)
         Monovision
         SV Toric one eye/ Multifocal one eye                                      ▫   C-vue Hydravue toric multifocal (Unilens)
         Toric MF Soft                                                             ▫   Intelliwave multifocal toric (Art Optical)
                                                                                   ▫   Proclear multifocal toric (CooperVision)
                                                                                   ▫   SpecialEyes toric multifocal (SpecialEyes)

                                                                                 Visual Performance of
Visual Performance of MF Toric SCL
                                                                                  MF Toric SCL
• 20 subjects                                                                    • Results:
     ▫ 45 to 65 yo                                                                 ▫ Performance of MV and MF within 1-2 letters
     ▫ 0.75DC to 2.75 DC                                                           ▫ Note:
                                                                                        60% of subjects:
• Cross-over design                                                                       < 50 yo
• Soft Toric MF vs Soft Toric MV                                                          Near add lower than +1.50
• 1 month wear of each design                                                           Astigmatic error in study population?

                                  Madrid-Costa D. et al, Visual Performance of                              Madrid-Costa D. et al, Visual Performance of
                                  a multifocal toric soft contact lens. Optom.                              a multifocal toric soft contact lens. Optom.
                                  Vis Sci. Nov 2012;89(11):1627-1635.                                       Vis Sci. Nov 2012;89(11):1627-1635.

                                                                                                                                                           12
12/27/2017

Soft Toric Multifocals                                           Soft Toric Fitting Tips
• Benefits                                                       • Fix astigmatism correction first
 ▫ Come in custom parameters                                      • Then employ multifocal fitting strategies
     High cylinder powers
     Custom add sizes                                            • Order 3 diagnostics per eye
• Challenges                                                      ▫ on spectacle axis and either side
 ▫ Currently limited to monthly, quarterly or annual                  What axes?
   replacement options
 ▫ No or limited diagnostic fitting sets

                                                                    Toric Lens Degrees of Lens Rotation Inducing
Initial Diagnostic Axes                                             Power (D) 0.75D* of Residual Astigmatism
                                                                       0.75                   30
• Assume 0.75DC of residual cylinder and above is                      1.25                   18
  unacceptable                                                         1.75                   12
• How much axis mislocation of a given toric power                     2.25                   10
  will induce this level of residual astigmatism?                      2.75                    8
 ▫ 30°mislocation: Residual cyl = toric power in lens                  3.25                    7
      Eg. -2.25 DC lens misaligns 30°= 2.25DC residual                 3.75                    6
          -2.25 DC lens misaligns 10°= 2.25/3= 0.75DC residual         4.25                    5
                                                                       4.75                   4.5
• Spectacle Rx: –1.00-2.25x090                                         5.25                    4
 ▫ Order axes: 090, 080, 100                                           5.75                   3.5

Corneal Astigmatism = Spectacle
                                                                 What do we fit?
Astigmatism
• A Multitude of Multifocal Options!                             • The Decision Drivers
 ▫ Toric Soft MF                                                  ▫ Astigmatic error
 ▫ GP MF (Corneal and Scleral)                                    ▫ What are they used to?
 ▫ Hybrid MF                                                          Are they happy?

                                                                                                                          13
12/27/2017

Hybrid Multifocal Designs
                                                 How well do Hybrid MF’s work?
• Duette Multifocal    • Duette Progressive
  ▫ Adds:               ▫ Adds:
     Small and Large        +1.00, +1.75,+2.50

                                                  • Method:
                                                    ▫ 16 presbyopic eyes
                                                    ▫ Duette MF vs Air Optix Aqua MF and Biofinity MF
                                                  • Conclusion:
                                                     “The Duette multifocal hybrid lens seems to
                                                    provide similar visual quality outcomes (as soft
                                                    multifocals) in presbyopic patients with low
                                                    corneal astigmatism….”

Hints on Hybrids                                 Scleral Multifocals!
                                                      Barnett M. Multifocal Scleral lenses. A look at
• Rigid Center                                        available lenses that can help our presbyopic
                                                      patients. Contact Lens Spectrum. December 2015.
  ▫ 0.50-0.75 STK
  ▫ 0.1 mm BC steps

• Soft Skirt
  ▫ Flat
     Good comfort
       No edge lift
     Good centration

                                                   • Corneal GP Lenses

                                                                                                               14
12/27/2017

 Selecting Seg Height                 Selecting Seg Height

 Selecting Seg Height                 How’s this look?
Goal: Just below lower pupil margin
     Where to start?
1mm below geometric center of lens

               10.0 mm /2 = 5.0 mm
                           -1.0 mm
                            4.0 mm

 What changes would you
 employ in this case?

                                                 0.50 D flatter
                                      Also consider increasing prism 0.50D

                                                                                    15
12/27/2017

         The Intermediate Distance?
                                                          Expert Progressive

Over Specs for Computer                                   GP Multifocal Developments

                                                           High Eccentricity                      Translating Design
                                                             Back Surface
                                                                               Low Eccentricity
                                                                                Back Surface

                            • Lenses compliments of                                                   Front Surface
                            Irving Yaross, OD (Chicago)
                                                                                                        Asphere

                                                          Presbyopes & Daily Disposables
What do we fit?                                           • Great for part-time wear
                                                          • Convenience
• The Decision Drivers                                    • Presbyopes have dry eye issues
                                                                Dry eyes lead to lens coating
 ▫ Astigmatic error
                                                                   Dirty lenses are responsible for
 ▫ What are they used to?
                                                                   many contact lens problems
     Are they happy?
 ▫ Safety and Convenience

                                                                                                                             16
12/27/2017

                                                                                          Multifocal Daily Disposables
Contact Lens Safety                                                                                   Alcon                                 CooperVision
     Incidence of CIEs:
        ○ DD vs Reusable:                                                                • Dailies AquaComfort Plus                • Proclear 1 Day Multifocal
           12.5 X less likely                                                              ▫ Center near                              ▫ Center near
                                                                                           ▫ Same optics as Air Optix Aqua            ▫ One add
           with DD1                                                                          Multifocal
        ○ DD SiHy vs DD Hyd:                                                               ▫ Three adds
            SiHy DD: 0.4%
            Hyd DD: 0%                                                                   • Dailies Total 1 for Presbyopia
                                                                                                Same optics as Dailies
      1.Chalmers, Robin L. et al, Multicenter Case-Control Study of the Role of Lens            AquaComfort Plus
      Materials and Care Products on the Development of Corneal Infiltrates,                    DT1 material
      Optometry & Vision Science. 89(3):316-325, March 2012.

      2. Chalmers RL et al, Rates of Adverse Events With Hydrogel and Silicone
      Hydrogel Daily Disposable Lenses in a Large Post Market Surveillance                           Davis R. Fitting Tips for Presbyopic Success, Rev Corn CL, Oct 2010
      Registry: The TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63               Quinn TG. Clinical Experiences With a Daily Disposable Multifocal,
                                                                                                     Contact Lens Spectrum, 28(11):19, November 2013

  Multifocal Daily Disposables
              Alcon                                         CooperVision
                                                                                         Multifocal Daily Disposables
                                                                                                       JJVC                                        VTI
                                                                                          • 1-Day AV Moist for Presbyopia             NaturalVue Multifocal 1 Day
 • Dailies AquaComfort Plus                       • Proclear 1 Day Multifocal
                                                                                            ▫ Moist material                            Center distance
   ▫ Center near                                     ▫ Center near
                                                                                            ▫ Center near                               Extended depth of focus
   ▫ Same optics as Air Optix Aqua                   ▫ One add
     Multifocal                                                                                   “pupil smart” design                  Single add (up to +3.00
                                                                                                    Changes with age                    effect)
   ▫ Three adds                                   • Clariti 1-Day Multifocal                        Changes with refractive
                                                    ▫ Center near                                   error
 • Dalies Total 1 for Presbyopia
                                                    ▫ Two adds
        Same optics as Dailies
        AquaComfort Plus
                                                    ▫ Silicone hydrogel material
        DT1 material

                                                                                                             JJVC = Johnson&Johnson Vision Care
                                                                                                             VTI = Visioneering Technologies, Inc

Multifocal Daily Disposables
                             Bausch+Lomb
  • BioTrue ONEday for
    Presbyopia
    ▫ HyperGel material
    ▫ Center near
           Same optics as PV2 for
           Presbyopia                                                                       •   Corneal GP Multifocals
           2 adds                                                                           •   Soft Multifocals
                                                                                            •   Hybrid Multifocals
                                                                                            •   Scleral Multifocals

                                                                                                                                                                            17
12/27/2017

                                                         Lens Selection
                                                       • Detailed refraction
Examination                                              ▫ “Push” Plus at distance
                                                            No more minus than absolutely necessary
Procedures               Techniques                      ▫ No more add than absolutely necessary

 Lens Selection
• Determine eye dominance                                Sighting vs Sensory Dominance
  ▫ Sighting dominance
                                                          • Pointer J, J of Optom, (2012) 5, 52-55
  ▫ Sensory dominance
                                                            ▫ Method:
                                                               72 Emmetropes
                                                                 Sighting method: hole in the card
                                                                 Sensory method: +1.50 blur test
                                                            ▫ Results:
                                                               Right eye dominance
                                                                 Sighting method: 71%
                                                                 Sensory method: 54%
                                                                 Laterality was in agreement only 50% of the time!

 Lens Selection                                          Assessing Performance
  • Follow the fitting guide!                            • Scouting report
    ▫ Distance Rx: most plus power equivalent sphere
                                                            ▫ Open-ended questioning
    ▫ ADD: follow the charts
                                                         • Real world environment
                                                            ▫ Lights up
                                                            ▫ Binocular conditions
                                                            ▫ Real world tasks
                                                            ▫ Loose lenses

                                                                                                                            18
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Assessing Performance                                   Adaptation to Multifocal Optics
• 20/40 line                                            • Sheedy et al, Optom Vis Sci, June 1993
                                                          ▫ Noted significant improvement in complex task
                                                            performance with concentric bifocal lenses
• Text based near tasks                                   ▫ No improvement with monovision
                                                        • Pappas et al, Eye Contact Lens, May 2009
• Don’t recheck too soon                                  ▫ Assess performance of 88 subjects at dispensing and after
                                                            4 days of wear
• Don’t make changes too soon                             ▫ “Early assessment is relatively unrepresentative of
                                                            performance later on during multifocal contact lens wear.”

                                                        • Fernandes et al, Optom Vis Sci, Mar 2013
                                                              Over 15 days, MF acuity at D and N improved
                                                              MV acuity remained the same or worsened

Adaptation to Multifocal Optics                         Enhancing Performance
• Lunghi C, Sale A                                      • 1: Always start with OR using loose lenses
  A cycling lane for brain rewiring                       ▫ To confirm distance Rx
  Curr Biol. Dec 7, 2015                                • 2: Follow the manufacturer’s guide!
• Old School: “Plasticity (of the brain) is maximal
  in early development…abruptly declines in
  adulthood.”
• “Recent studies…have revealed a significant
  residual plastic potential of the adult visual
  cortex…”

When is enough…enough.                                  The Current Monovision Wearer
• You’ve set the right tone                             • Do you have difficulty with night driving?
 ▫ The Sandwich Approach                                • Do you have problems at intermediate
• You’ve confirmed the Rx                                 distances?
 ▫ Always confirm distance Rx first
                                                        • Do you have problems with depth perception?
• You’ve shared The 3 Revelations
 ▫ “The goal is to meet most of your needs most of
   the time”
 ▫ “You may need to give up a little bit of crispness
   for freedom”
 ▫ “This is as good as it gets”

                                                                                                                           19
12/27/2017

Transitioning Monovision Wearers to   Transitioning Monovision Wearers to
Multifocals                           Multifocals
• Most common challenge?              • Most common challenge?
 ▫ Distance vision                      ▫ Distance vision
• Why?                                • Why?
 ▫ Interference from the add            ▫ Interference from the add
• Treatment strategy?                 • Treatment strategy?
 ▫ Reduce add in dominant eye           ▫ Reduce add in dominant eye
    What’s the lowest add?                 What’s the lowest add?     NO ADD!

The Emmetropic Presbyope
                                      Smart Lens for Presbyopia
                                      • Process:
                                        ▫ Liquid crystal changes in response to an
                                          electrical signal
                                           curve change
                                           index change
                                      • Trigger:
                                        ▫ Convergence
                                           Change in PD?
                                           Gaze change?

Many Thanks!

                                                                                            20
12/27/2017

                                                           Disclosures
                                                             Alcon
                   Thomas G. Quinn, OD, MS                   Allergan
                                Athens, OH                   Bausch & Lomb
                       tgquinn5@gmail.com
                                                             BioScience Communications
                                                             CooperVision
                                                             GPLI
                                                             STAPLES Program
                                                             JJ VC Vistakon

The Role of Contact Lenses Today                           Current Contact Lens Services
  Three Legs of the Stool of Success                         Cosmetic
   Good Vision                                                Vanity
   Good Comfort                                               Improved self esteem (Walline)
   Good Health

Adult Perceptions:                                         Adult Perceptions:
Judgements Toward Male                                     Judgements Toward Female
Spectacle Wearers                                          Spectacle Wearers
  More feminine                                             Generally less attractive
  More physically attractive                                Less honest
  More honest                                               Less successful
  More successful                                           More of a follower
  More of a leader

                                  RL Terry, October 1989                                       RL Terry, October 1989

                                                                                                                                1
12/27/2017

Adult Perceptions:
Judgements Toward Female
Spectacle Wearers
 Generally less attractive
 Less honest
 Less successful
 More of a follower

                                      RL Terry, October 1989

Child Self Esteem                                                   The ACHIEVE Study
 Survey* of 711 females and 309 males                               The Adolescent and Child Health Initiative
 aged 12 to 17 years                                                  to Encourage Vision Empowerment
 95% of teens said appearance effected                                Study
 their confidence
 52% said not having to wear glasses                                    A 3-year randomized clinical trial to
 would make them feel more confident                                    investigate the effects of contact lenses vs.
                                                                        spectacle wear on children’s self-perception
                                                                        Ages 8 to 11 yo
                         * by Johnson and Johnson, 2006
                                                                        Five clinical sites (OH,OR,MA,TX,TN)

The ACHIEVE Study                                                   Current Contact Lens Services
 Physical appearance                                                  Cosmetic
   Largest difference; independent of initial attitude                  Vanity
 Athletic competence                                                    Improved self esteem (Walline)
   Peripheral vision; prior removal of spectacles?                    Visual Freedom
 Social acceptance
   Stable for spectacles, but increased for CL’s
 Scholastic competence
   More if initial dislike of spectacles; removed?

                           Walline et al, Optom Vis Sci, Mar 2009

                                                                                                                                2
12/27/2017

Current Contact Lens Services
  Cosmetic
   Vanity
   Improved self esteem (Walline)
  Visual Freedom
  Optics
   Irregular cornea
   occluder

                                    Current Contact Lens Services
                                      Cosmetic
                                       Vanity
                                       Improved self esteem (Walline)
                                      Visual Freedom
                                      Optics
                                       Irregular cornea
                                       occluder
                                      Bandage
                                       Protection
                                       Comfort

New Applications                    Therapeutic applications
  Therapeutic                         Myopia control
  Digital                             Drug delivery

                                                                                3
12/27/2017

Optics to reduce myopic                                                                Optics to reduce myopic
progression                                                                            progression
 The Problem:                                                                           The Problem:
  Peripheral rays normally focus                                                         Peripheral rays normally focus
 behind the retina (hyperopic defocus)                                                  behind the retina (hyperopic defocus)
  Leads to axial elongation                                                              Leads to axial elongation
                                                                                        The Solution:
                                                                                          Add plus into the periphery of the optical
                                                                                         system to create myopic defocus
                                                                                        How?

                                                  From Paul Gifford and Kate Johnson
                                                                                                                                                   From Paul Gifford and Kate Johnson

Optics to reduce myopic
                                                                                       The LORIC Study
progression
                                                                                       Longitudinal Orthokeratology Research
 Corneal reshaping                                                                                   in Children
 (orthokeratology)
                                                                                        Control= SV spectacle wearers

                                                                                              *Cho, P et al, Curr Eye Res, Jan 2005

Optics to reduce myopic                                                                Optics to reduce myopic
progression                                                                            progression
 Corneal reshaping (orthokeratology)
                                                                                        Corneal reshaping                        1. Li SM et al., Studies using concentric ring bifocal and
                                                                                                                                 Peripheral add multifocal contact lenses to slow myopia
   32-62% reduction                                                                                                              Progression in school-aged children: a meta-analysis, Opthal.

                                                                                        Dual Focus Soft Lenses                   Physiol Opt, Jan 2017

                                                                                           30-50% myopia control rate over 2 years1
                                                                                        Comparison?
                                                                                                                                2. Turnbull PR et al, Contact Lens Methods for Clinical Myopia
                                                                                           No difference in efficacy2           Control, Optom Vis Sci. Sept 2016

         Bickle K and Nichols J, Myopia Control
         Today, CL Spectrum, Aug 2014.

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Optics to reduce myopic                                                     Optics to reduce myopic
progression                                                                 progression
  Corneal reshaping               Soft multifocal                            Soft Lens Options?
   32-62% reduction                  34-79% reduction
                                                                               Nothing approved yet
                                                                               Off-label use: Center Distance multifocals
                                                                               ○ Biofinity Multifocal: D design (CooperVision)
                                                                                   Monthly replacement
                                                                               ○ NaturalVue Multifocal (Visioneering Technologies)
                                                                                  Daily disposable
                                                                               ○ Various custom lenses

           Bickle K and Nichols J, Myopia Control
           Today, CL Spectrum, Aug 2014.

Drug delivery                                                               Drug delivery
  Anti-allergy                                                               Anti-allergy
  Anti-inflammatory                                                          Anti-inflammatory
  Anti-infective                                                             Anti-infective
                                                                             Tools:
                                                                               ○ Vitamin E
                                                                                   hydrophobic
                                                                               ○ Nanoparticle encapsulation
                                                                                  Thick gel; inconsistent release
                                                                               ○ Molecular Imprinting Technology (MIT)
                                                                                  Alterations in CL parameters
                                                                                             Hui,A. et al Inv Ophthal and VisSci 2014;55,8:48. 96-4904

Anti-infective                                                              Drug delivery
  Bug resistant lens!                                                        Anti-allergy
  Melimine-coated contact lens                                               Anti-inflammatory
   Not an antibiotic                                                         Anti-infective
    ○ From bee venom and salmon sperm
                                                                             Anti-glaucoma
   Cationic peptide (antimicrobial)
                                                                               Drug delivery
  Possible issue:                                                              IOP monitoring
   Increased corneal staining

                                   Dutta et al. Optom & Vis Sci, May 2014

                                                                                                                                                         5
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The Digital Revolution!                                                     Digital applications
                                                                             IOP monitoring

Digital applications                                                        Digital applications
 IOP monitoring                                                              IOP monitoring

                                                                                                     Asrani SJ et al. Glaucoma 2000;9:2:134-42.
    Realini T, Weinreb RN, Wisniewski SR. Ophthalmology 2010;117:9:1700-4

Digital applications                                                        Digital applications
 IOP monitoring                                                              IOP monitoring
   Triggerfish (Sensimed)                                                      Triggerfish (Sensimed)
   US Approval: March 2016                                                     ○ detects tiny changes or fluctuations in the
   Specifications:                                                              eye’s volume
                                                                                   1-7% change in volume with IOP changes
   ○ Silicone hydrogel
   ○ 14.1 mm diameter
   ○ 585 microns center thickness (vs 70-80 microns)
   ○ BC: 8.4, 8.7, 9.0 mm

                                                                                                                               (From Dunbar GE et al, Clin.
                                                                                                                               Ophthal, May 2017)

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Digital applications                                                             Digital applications
     IOP monitoring                                                                IOP monitoring
        Triggerfish (Sensimed)                                                      Triggerfish (Sensimed)
        ○ 30 sec measurement every 5 min for 24 hrs                                 ○ Accurate when compared to 2 other methods
            86,400 data points (millivolt equivalents)                              ○ Upright lower than supine
                                                                                       May be less of a difference in low/moderate myopes
                                                                                       Liu et al. Inv Ophth Vis Sci, 8/2002; 43(7):2351-5.

Two 24 hour profiles of the same patient before and one month after treatment.                                  Twa M. J. Glaucoma. 5/2011; 21(8):539-44.

Triggerfish                                                                      Triggerfish
     Tolerability                                                                  Cost
        95% willing to use device again                                             Upfront reusable items
     Safety                                                                         ○ data recorder, cable, software
                                                                                    ○ $7,310 (approx.)
        Mild adverse events common (75-95%)
        ○ Transient blur, conj hyperemia, SPK                                       Single use items
                                                                                    ○ CL, orbital antenna and recorder sleeve
     Reproducibility
                                                                                    ○ $526-682
        Fair to good
     Validity at estimating IOP
        Still in question
                                  Dunbar GE et al, Clin Opthalmol., May 2017.                             Dunbar GE et al, Clin Opthalmol., May 2017.

Triggerfish Application                                                          Triggerfish Application
     IOP monitoring                                                                Wind Instrument Player IOP
        Triggerfish (Sensimed)                                                      Professional: +2.5 + 1.5 mmHg
        ○ One study findings lead to immediate                                      Amateurs: +1.1 + 2.3 mmHg
          treatment change in two-thirds of patients

                                                                                   Conclusion:
                                                                                    “These peaks may be relevant for
                                                                                    glaucomatous field progession and
                                                                                    treatment in glaucoma patients.”
                  Mansouri K, Shaarawy T, Br J Ophthalmol, 2011;95(5):627–9
                                                                                                        De Cromdf RMPC et al, J. Glaucoma, Aug 2017.

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Digital applications                                                         Night Vision Goggles
 IOP monitoring
 Night vision
   Infrared light
   “Heat Vision”

Digital applications                                                         Graphene
 IOP monitoring
 Night vision
   Infrared light
   “Heat Vision”
   ○ Graphene
      Single layer of carbon atoms
   ○ Stays cool!

Digital applications                                                         Digital applications
 IOP monitoring                                                               IOP monitoring
 Night vision                                                                 Night vision
 Cancer detection                                                             Cancer detection
   Elevated tear protein: lacryglobin
                                                                              Diabetic monitoring
   ○ Condition (%) with lacryglobin detected in tears
      Breast cancer (88%)
      Colon cancer (100%)
      Lung cancer (83%)
      Prostate cancer (100%)
      Ovarian cancer (33%)
      Control (60%)

           Evans V et al. Clin Experiment Ophthalmol. 2001 Jun;29(3):161-3

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Impact of Diabetes                                                          Impact of Diabetes
 In 2010:                                                                    Daily pills
   25.8 million Americans                                                      Blood sugar
   8.3% of the population                                                      Blood pressure
 In 2012:                                                                      cholesterol
   29.1 million Americans                                                    Injections?
   9.3% of the population                                                    Diet control
 In 2015:                                                                    Finger prick readings
   30.3 million Americans
   9.4% of the population

Impact of Diabetes                                                          Diabetic Monitoring
 “Between 10% and 18% of patients
 reported that they would be willing to
 give up eight to 10 years of life in good
 health to avoid life with treatment”

                         Huang ES. Diabetes Care. 2007 Oct;30(10):2478-83

Diabetic Monitoring                                                         Indefinite Delay
 Google’s “smart” contact lens                                               November 21, 2016 Press Release
                                                                               “It is too early to say when exactly
                                                                               human clinical trials for these lenses will
                                                                               begin. This is a very technically complex
                                                                               process and both sides are learning as
                                                                               we go along. We will provide updates at
                                                                               the appropriate time.”
                                                                                                  Novartis Spokesperson

  Note: 20 minutes between change in blood glucose and tear glucose

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Diabetic Monitoring                                           Self Generating Power Source
 Transparent Sensor! (Nov 2016)                                Smart CL Power Source:
   Oregon State University College of Engineering               Wireless external source
   Nanostructure
                                                               New Idea from Switzerland:
   ○ Amorphous indium gallium oxide field effect transistor
     (IGZO FET)                                                 Electric Eel-Inspired Battery (knifefish)
   ○ Employs innovative techniques                               ○ Energy created from fresh and salty water
      Acts like an inkjet printer, but:                           mixing together
      - finer drop sizes
                                                               Renewable fluid stream:
      - biological materials instead of ink
   ○ Low cost fabrication
                                                                The Tear Film!
                                                                                    Schroeder, TBH et al., An electric-eel-inspired
   ○ Working on communication                                                       soft power source from stacked hydrogels,
                                                                                    Nature; 14th December 2017
     system

Digital applications                                          Smart Lens for Presbyopia
 IOP monitoring                                                Process:
 Night vision                                                   Liquid crystal changes in response to an
                                                                electrical signal
 Cancer detection
                                                                 ○ curve change
 Diabetic monitoring                                             ○ index change
 Presbyopia                                                    Trigger:
                                                                Convergence
                                                                 ○ Change in PD?
                                                                 ○ Gaze change?

Digital applications                                          Mood Regulation
 IOP monitoring                                                Seasonal Affective Disorder
 Night vision                                                    Contact Lens regulates light
 Cancer detection                                                Emits desired wavelength and brightness
                                                                 ○ Stimulates cells to downregulate melatonin
 Diabetic monitoring                                              and upregulate serotonin
 Presbyopia
 Mood Regulation

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Digital applications                                                Augmented & Virtual Reality
  IOP monitoring                                                     Virtual Reality (VR)
                                                                       an artificial, computer-generated simulation or recreation
  Night vision                                                         of a real life environment or situation. It immerses the user
  Cancer detection                                                     by making them feel like they are experiencing the
                                                                       simulated reality firsthand, primarily by stimulating their
  Diabetic monitoring                                                  vision and hearing.
                                                                       Uses:
  Presbyopia                                                           ○ Video and computer games

  Mood Regulation                                                      ○ 3D movies
                                                                       ○ Enhanced training (eg. Flight simulators)
  Augmented & Virtual Reality

Virtual Reality                                                     Augmented & Virtual Reality
                                                                     Augmented Reality (AR)
                                                                       a technology that layers computer-
                                                                       generated enhancements atop an existing
                                                                       reality in order to make it more meaningful
                                                                       through the ability to interact with it.
                                                                       Uses:
                                                                       ○ Telecasted sports games
                                                                       ○ Pop out 3D emails
                                                                       ○ Mobile device photos or texts
                                                                       ○ Medicine
    https://www.youtube.com/watch?v=AB-dhUs9U1k

Augmented & Virtual Reality                                         Google Glass
                                                                     Camera
  North America                                                        Photos and videos
   Largest market due to:                                            Touchpad
                                                                       Weather
   ○ Highest penetration of AR and VR technology                       Phone calls
                                                                       Maps
   ○ Higher spending on such technologies
                                                                     Apps
   ○ Higher R&D investments by major players                           Exercise programs
       Google Inc                                                      Facebook, Twitter
                                                                       News
       Microsoft Corp.                                                 Face recognition?
       Vuzix Corp.                                                   In a contact lens?
       Samsung Electronics Co., Ltd                                    Controlled by blinks
       Qualcomm Inc                                                    Discreet
                                                                       Privacy concerns?
       Sony- after 4 mo of sales, nearly 1 million sold @$500 ea.

                                   PR Newswire, Jan 19, 2017

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Google Glass                                         Augmented & Virtual Reality
 What happened?                                       Major Applications:
   Unnatural!                                           Gaming
   ○ Low resolution                                     Medical
   ○ Off-angle display                                  Aerospace and Defense
   ○ 15 degree diagonal                                 Commercial
    field of view
                                                        Others
   ○ Display in one eye
    only

Augmented Reality                                    Digital applications
                                                      IOP monitoring
                                                      Night vision
                                                      Cancer detection
                                                      Diabetic monitoring
                                                      Augmented reality
                                                        Google Glass in a Contact Lens
                                                        iOptik (Innovega)

       https://www.youtube.com/watch?v=kC7OlweCJ8I

Augmented & Virtual Reality                          eMacula (Innovega)
 Benefits of CL over Spectacles                       AR/VR through combination
   Eye tracking important feature                     of spectacles and CLs
   ○ CLs do no interfere                              Approval: early 2018?
   Allows for less bulk and lighter headsets          Cost?
                                                        Contact lenses approx. 20%
                                                        more than regular disposables
                                                        Glasses will cost “little more”
                                                        than the price of regular
                                                        designer spectacles
                                                      www.emacula.io

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eMacula (Innovega)                                Our Role in the Future
                                                   Basic Contact Lens Rules still apply!
                                                     Good vision: “Looking through wires”
                                                     Good comfort: IOP sensing device is 8x
                                                     thicker than standard CL
                                                     Good health: staining with melamine-coated
                                                     anti-microbial lens

Our Role in the Future                            Our Role in the Future
 Lens Surface remains important                    Growing need for our services!
   Current strategies                                New populations
   ○ Surface chemistry                               New possibilities!
   ○ Frequent disposal: 12.5 x reduction in
    inflammatory events with DD vs Reusable
   ○ Can these high tech devices be disposed of
    frequently?

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