Controversies in Scleral Lenses 2019 Curvature Versus Elevation

Controversies in Scleral Lenses Normal Keratoconus PMD Keratoglobus 2019

Curvature versus Elevation

Axial Display Elevation Map Power Map Height Map

Axial Display Elevation Display Patient CB Moderate KC Axial Display Map +180um +180 +379 +379um Elevation Display -110 - 276 Elevation Map 655 Above the 290 microns Micron Sphere Height -276um Differential Depression Below the -110um Sphere

N = 87 Patients 127 CL Fits

Less than 350um Greater than 350um

Patients with 350um or less of corneal elevation difference (along the greatest meridian of change) have an 88.2% chance of success with a corneal GP lens.

The Re-Birth of Scleral Lenses Glass Scleral Lenses 1887 Molding Glass Scleral Lenses Average 8.5

High DK Scleral Materials Traditional Corneal / Scleral • Menicon Z Dk = 163 Shape • B & L, Boston XO2 DK = 141 • Contamac, Optimum Extreme DK = 125 • B & L, Boston XO DK = 100 • Paragon HDS 100 DK = 100 • Contamac, Optimum Extra DK = 100 • Lagado, Tyro -97 DK = 97

Scleral Shape Cone Angle Circa 1948 Klaus Pfortner New Understandings Argentina Scleral Lens Fitting Objectives Anatomy of a Scleral Lens

1. Central Vault Zone (250 to 400 microns)

2. Peripheral Lift Zone 4 3 2 1 2 3 4 3. Limbal Lift Zone

4. Scleral Landing Zone

Ocular Surface Disease Scleral Lens Indications Scleral Irregular Astigmatism Lens • Keratoconus Indications • Pellucid Marginal Degeneration • Post Corneal Trauma • Post keratoplasty • Post K-Pro • Post Refractive Surgery RK, PRK and LASIK • Post HSV and HZV • Athletes • GP stability (rocking) issues Corneal Irregularity Ectasia/Scar/Post Surgery

•) Scleral Lenses Pathologic Ocular Surface Disease • Chemical Burns for Ocular • Ocular Pemphigoid Surface Disease • Stevens-Johnson Syndrome • Symblepharon formation • Graft vs Host Disease • Persistent Epithelial Defect • Exposure Keratitis • Neurotrophic Keratopathy • Sjogren’s Syndrome, • Filamentary Keratitis • Limbal Stem Cell Deficiency • Radiation Keratopathy SJS 20/400 6 months Ocular Surface Disease… Post Scleral Lens 20/25

Pre-Scleral 2 Months Post Scleral

9 Lens Ampleye Low Sag Eyes and Scleral Lens Normal Eyes Fitting bySagittal Height Diagnostic Set 3,800 microns 4,000 microns 4,200 microns Mild KC, Mild PMD and Corneal Transplants 4,400 microns 4.600 microns Advanced KC, PMD Bulging Grafts 4,800 microns 5,000 microns Extreme Ectasias 5,200 microns 5,600 microns

Markings on Ampleye Diagnostic and Patient Lenses

Rotation Markings Along the Flat Meridian Initial diagnostic lens selection is based on Diadmostic Fitting…. corneal height/optical condition. Filamentary Keratitis

Scleral Lens Application Preservative Free Saline Options (in the USA) The unit dosed 5 or 10 ml Inhalation PF saline.... 0.9% Sodium Chloride Solution by Rx only

The 12 OZ aerosol saline… Simply Saline by Arm and Hammer OTC

The 4 OZ bottle Purilens Plus Ultra PF Saline from Purilens OTC

Application Bubble LacriPure Saline from Menicon Re-Application Central Vault Zone 250 to 400 microns of Apical Clearance

Scleral Lens Setteling

8 hour Approx. White Light Cobalt Light Lens Baseline 130 um Settling 400 um

30 mts. 4 hr.

1 hr. 340 um (60 um) 6 hr.

8 Hours 2 hr. 270 um (130 um) Limbus Dispensing 4,200 Inadequate Peripheral Corneal Clearance

Appropriate Peripheral Corneal Clearance

Dispensing Peripheral Lift Zone 4,000 um PLZ Changes The change in sag between the Standard and +5 PLZ is: 125 microns.

Post 4 Hours

Peripheral Inadequate Limbal Clearance Lift Zone Light +5 increase = 125 um Peripheral Bearing

Adequate Corneal and Limbal Clearance Over-Refraction Patient: TW KATT for KC Axial Map

TW Elevation Map Initial Diagnostic Lens Selection

TW Right Eye Inadequate Appropriate Apical Clearance Apical Clearance Sag = 4,400 9 Lens Ampleye Low Sag Eyes and TW Right Eye Normal Eyes Diagnostic Set 3,800 microns Sag = 5,000 4,000 microns 4,200 microns Mild KC, Mild PMD and Corneal Transplants 4,400 microns 4.600 microns Advanced KC, PMD Bulging Grafts 4,800 microns 5,000 microns Extreme Ectasias 5,200 microns 5,600 microns

Right Eye Pellucid Marginal Degeneration

Right Eye Initial Diagnostic Lens Selection Peripheral Lift Zone Right Eye PLZ Changes

The change in sag between the Standard and a +5 PLZ is 125 microns.

KC With Intacs

Ten Days Post-Surgery

Budging Graft Sag = 5,780 um

Normal Eye Sag = 3,735 um

One Week After Scleral Lens Wear Axial Display Map Total Height Differential 485 microns Increase PLZ +10 = 250 microns

Elevation Display Map Diagnostic Lens Final Lens

193 um Elevation

292 um Depression

Precision Ocular Metrology sMap3D Eaglet ESP Eye Surface Profiler

150 un Temporal Nasal Differential between steep and flat meridians

LR MR Temporal Nasal Average Sagittal Height and Scleral Lens Position

OCT

Toric Scleral Lens Design

Spherical Corneal Zone

Lowest Scleral Toric Scleral Lens Design Meridian

Highest Spherical Scleral 9.5 mm Meridian Optical Zone Toric Scleral Lens Design

Scleral Landing Zone

Scleral Landing Zone Conjunctivial “Compression” Summary of Fitting Techniques

Scleral Lenses 2016

Corneal Astigmatism vs Scleral Medmont Topography Astigmatism Beth Kinoshita Sheila Morrison The sMap 3D was used to measured the position of 20 subjects SCLERL astigmatism. All 20 subjects had with-the-rule CORNEAL astigmatism. Visionary sMap3D 20.0 mm Chord 16.0 mm Chord

16.0 mm Chord 17.5 mm Scleral Lens

Low Corneal Astigmatism < 0.75 D High Corneal Astigmatism > 1.75 D

The sMap 3D was used to measured the Lowest Scleral position of 20 subjects SCLERL astigmatism. Meridian All 20 subjects had with-the-rule CORNEAL astigmatism. • 7 had Asymmetric scleral toricity at a 15.0 mm Spherical Highest Scleral chord. 9.5 mm Meridian • 4 had Against the rule scleral toricity at a 15.0 Optical Zone mm chord. • 5 had Oblique scleral toricity at a 15.0 mm chord. • 4 had With the rule scleral toricity at a 15.0 mm chord. Toric Scleral Design Highest Scleral Meridian

Spherical 9.5 mm Optical Zone Lowest Scleral Meridian

Toric Scleral Design Difficulties with Scleral Lenses A B C

Right Eye Left Eye Right Eye Left Eye

Uncomfortable Uncomfortable Uncomfortable Comfortable Right Eye Left Eye

Uncomfortable Comfortable

Is the oxygen permeability of our When Things Go current GP lens materials adequate Wrong With for today’s scleral lens designs? Scleral Lenses

Pacific University 12 SubjectsIndividual Overnight OvernightCorneal Swelling Swelling Scleral Lens Corneal Swelling Project No ContactAverage Lens = 2.85 Wear 6 Contamac Comfort DK 65 5.54 5 Average 4.48 4.18 Contamac Extra DK 100 4 Corneal Swelling 3.56 3.56 3.41 3.31 3.25 2.8% Contamac Extreme DK 125 3

2 1.78 1.36 1 0.38 0

-1 -1.25 -2 1 2 3 4 5 6 7 8 9 10 11 12 Normal Non-Lens-Wear Corneal Clear PKP with Endothelial Swelling = 2.80% Dysfunction Contamac Comfort DK 65 N = 16 Average Swelling in Percentage: 2.27%

Contamac Extra DK 100 N = 16 Average Swelling in Percentage: 1.54%

Contamac Extreme DK 125 N = 16 Average Swelling in Percentage: 1.39% Normal 18 y/o 78 y/o Post PKP 3,065 cells/mm2 480 cells/mm2

High DK Scleral Materials • Menicon Z DK = 16o

• B & L, Boston XO2 DK = 141 • Contamac, Optimum Extreme DK = 125 • B & L, Boston XO DK = 100 • Paragon HDS 100 DK = 100 • Contamac, Optimum Extra DK = 100 • Lagado, Tyro -97 DK = 97

Scleral Lenses on an Overnight / Do Scleral Lenses Provide Adequate Extended Wear Basis??? Oxygen Permeability for Overnight Lens Wear? Primary reasons: Paul Nefedov, Sheila Morrison OD, MS, Patrick Caroline, Randy Kojima and Beth Kinoshita OD • to provide protection • Ten normal eye subjects participated in this two part for persistent corneal study. erosions • In Phase 1 baseline overnight corneal swelling for each • to promote more subject with no CL wear. rapid wound healing. • In Phase 2, only the right eye of each subject was fitted with a 0.45 mm thick, plano scleral lens manufactured in

the Boson XO2 material (Dk 141). The lens was worn Is there adequate oxygen permeability overnight on the right eye for 8 hours. • Corneal thickness was measured immediately upon through scleral lenses in the closed eye awakening, and the percent of corneal swelling was environment ??? calculated. Range of 7.5% to 14.1%

Pre Overnight Lens Wear Post One Week Overnight Lens Wear

Post Two Week Overnight Lens Wear Post One Month Overnight Lens Wear

What is the best scleral lens AMPLEYE Application application solution PF Unisol saline, PF inhalation saline or PF artificial tear....other?

pH = 7

pH = 5

Preservative Free Saline Options (in the USA) LacriPure Saline from Menicon

The unit dosed 5 or 10 ml Inhalation PF saline.... 0.9% Sodium Chloride Solution by Rx only

The 12 OZ aerosol saline… Simply Saline by Arm and Hammer OTC

The 4 OZ bottle Purilens Plus Ultra PF Saline from Purilens OTC Right Eye Boston What are the mechanisms for Conditioning “Epithelial Bogging” and should we Solution be concerned about it? for Lens Application

Left Eye

Epithelial Post Lens Tear Film “Fogging” “Bogging”

Baseline OCT

1 Week Post-Fitting 4h post application

8h post application

2 Months Post-Fitting

Scleral Lens

Tear Film

Cornea

Tear Film “Fogging” The Human Tear Film Tear Reservoir Proteins Mucous Layer Proteins* 1600 • Mucopolysaccharide • Lysozyme 1400 • glycoproteins • Lipocalin 1200 • N-Ac-glucosamines • IgA Turbid Clear • sialic acid • Lactoferrin 1000

• fucose *Mann and Tighe 2007 • mannose 800 • Galactose Lipid Layer 600

• Wax esters 400 Aqueous Layer • Cholesterol esters • water 98% • Fatty acids 200 • solids 2% peptidesof# per 12.5ul sample • Free cholesterol 0 • Inorganics r r in -1 C o in o n n B in • Triacylglycerol r e t io io - e r in e rs t p t fe l m u o e g g in o s a y c r c re re b r • cations c z e p e p n o o r e r C C lo o (TAG) ra p s p l r g c t i y b G in i a y o L L in i g a a l • Anions t c i h h m g c m u c c c m - • OAHFA a u d ri a 2 L b in e 1 a - l a p M • Organics a in m h p a t ly p a h m c o l k lp ru la P a G a e o - I - S r g c • glucose P I in • Urea Z Maria Walker MS OD Proteins Sheila Morrison

The Human Tear Film Mucous Layer Proteins* • Mucopolysaccharide • Lysozyme • glycoproteins • Lipocalin • N-Ac-glucosamines • IgA • sialic acid • Lactoferrin Oil-Red-O Oil-Red-O • fucose *Mann and Tighe 2007 • mannose Lipid Stain Lipid Stain • Galactose Lipid Layer In a Non- In a • Wax esters Aqueous Layer • Cholesterol esters “Cloudy” “Cloudy” • water 98% • Fatty acids • solids 2% • Free cholesterol Patient Patient • Inorganics • Triacylglycerol • cations (TAG) • Anions • OAHFA • Organics • glucose • Urea

Tear Reservoir Lipids: Cholesterol Tear Reservoir Lipids: Cholesterol 400 CLEAR Fogged 350

300

250

200 Fog Samples

150 Clear Samples

100 Cholesterol (ug/ml)

0 C1 C2 C3 C4 F1 F2 F3 F4 F5 Tear Reservoir Samples Peripheral Corneal/Limbal Landing Managing “Fogging” Design

What is the best lens care system Hydrogen Peroxide for cleaning and disinfecting scleral Lens Disinfection lenses?

Dalsey Adaptives LLC Lens Storage Cases Springfield, Massachusetts

ClearCare Case Dalsey Adaptives 8.0 to 18.0 mm 8.0 to 24.0 mm Dalsey Adaptives LLC The EZ Eye Scleral Lens Applicator Springfield, Massachusetts (Q-Case Inc.)

Application Bubbles....

Why do we see so much initial non- How do we best manage surface wetting of these lenses and how do debris and deposits? we best manage it? Should scleral lenses be Plasma Treated and “wet shipped”?

When is it appropriate to place the patient on the “Progent” lens Surface cleaning regime? Deposits Non-Wetting Is there tear exchange beneath well Pre-Cleaning fitted scleral lenses?

Post-Cleaning

Tear Exchange Study #1 Subject SM 1. A scleral lens was placed on the right eye of 3 subjects, using fluorescein dissolved into PF saline as the application solution. 2. Subjects wore the lens for 8 hours and photography was performed at 30 min, 1, 2, 4, 6, and 8 hrs. 2. Anterior segment OCT was performed at each Right Eye Baseline Left Eye time point to monitor lens settling. 30 mts. 1 hr. 2 hr. 4 hr. 6 hr 8 hr.

SM Right Eye Baseline Post 8 hrs.

Apical Clearance Apical Clearance 420 um 250 um SM Right Eye 8 hr. Post-Fitting

Why don’t we see more microbial keratitis infections in our diseased eyes wearing scleral lenses?

Anything new related to the condition Inferior called conjunctival prolapes? Conjunctival Prolapse Superior Prolapes Conjunctival Prolapse

Transient Axial Display Elevation Display Conjunctival Prolapse

Conjunctival Prolapse

Axial Display Elevation Display

Conjunctival Conjunctival Prolapse Prolapse Is it OK ??? Controversies Scleral Lenses

Conjunctival Prolapse…Suction??? Tear Exchange Beneath Scleral Lenses? Sheila Morrison, Maria Walker OD MS, Patrick Caroline, Beth Kinoshita OD, Matt Lampa OD, Mark Andre, Randy Kojima Pacific University College of Optometry, Forest Grove, Oregon Introduction Study #2 Discussion During corneal GP lens wear, 20% of the post lens tear volume is October 2012 In Study #2, scleral lenses filled with clear PF saline were place onto one eye of three Due to normal lens settling into the soft tissue of the bulbar exchanged with each blink. With soft contact lenses, the exchange is subjects and photographed with white and cobalt blue light. Following 30 minutes of conjunctiva, the volume of fluid in the tear reservoir decreases from less than 1%. Therefore, a lingering question remains, “how much lens “settling”, PF fluorescein drops were instilled onto the superior bulbar conjunctiva baseline to 8 hrs. This must be taken into consideration when tear exchange takes place beneath modern scleral lenses?” To every 20 minutes for 8 hours (total 23 drops). At 8 hours the amount of fluorescein subjectively comparing baseline images to 8 hr. images. address this question we performed two pilot studies. present beneath the lens was photographed and subjectively compared to the baseline Baseline 1 hr. 8 hrs. Study #1 images. Anterior segment OCT was performed at baseline and at 8 hours to monitor Dr. Peter Wilcox’s In Study #1, a scleral lens was placed on the right eye of 3 subjects, lens settling. using fluorescein dissolved into PF saline as the application solution. Subjects wore the lens for 8 hours and photography was performed Subject #1 AM Dispense Subject #2 AM Dispense Subject #3 AM Dispense at 30 min, 1, 2, 4, 6, and 8 hrs. Anterior segment OCT was performed Fluorescein is clinically accepted to characterize the volume of tear at each time point to monitor lens settling. beneath rigid contact lenses. Both of our pilot studies showed via the Practice in Subject #1 Subject #2 Subject #3 presence (Study #1) or absence (Study #2) of fluorescein glow with cobalt blue light, that the fluorescein molecules did not readily exchange beneath the lens. It is possible that the larger fluorescein Subject #1 Post 8 hr. Subject #2 Post 8 hr. Subject #3 Post 8 hr. molecules have more difficulty passing into and out of the tear reservoir as compared to the aqueous component and smaller Virginia particles in solution and tears. Conclusions ❖ Based on our fluorescein studies, it would appear that minimal tear exchange takes place over 8 hours. Results of Study #2 ❖ Molecular analysis of the post lens fluid will be needed to quantify The average amount of 8 hour lens settling in the 3 subjects was 123 um. The post 8 hr. tear exchange beneath a scleral lens, and clarify the compositional white light images showed no evidence of conjunctival compression or impingement. changes of the solution during lens wear. Results of Study #1 Subjective observation of the cobalt blue images showed little or no fluorescein beneath The average amount of 8 hour lens settling in the 3 subjects was 133 ❖ Characterization of tear exchange beneath these lenses has the lens following 8 hours of lens wear. um. Subjective observation of the fluorescein showed little or no important implications for solution development, as well as the advancement of medical therapies using scleral lenses. fluorescein exchange throughout the eight hour period.

Terrien’s Marginal Degeneration Without Scleral Lens With Scleral Lens

Angle = 28.6 Degrees Angle = 19.9 Degrees

Scleral Lens 16.5 mm Material DK = 100 IOP = 20 mmHg IOP = 30 mmHg

IOP Measurement with Diaton Does Scleral Lens Wear Influence Intraocular Pressure? Emily Korszen OD Pacific University College of Optometry

179 GSLS January 2017 Does IOP Increase During Scleral Lens Wear? Steven Turpin OD and Kennedy Antoniuk

No Lens Wear AM and PM

GSLS January 2018

5 mmHg 5 mmHg 7 mmHg Increase Increase Increase in IOP Scleral Lenses in in IOP in IOP Place for 8 Hours

Impact of Scleral Lens Wear on 11 of the 28 had increases in IOP Intraocular Pressure and Posterior of 10 mmHg or GREATER Ocular Perfusion Pabita Dhungel PUCO, MSc Vision Science

186 Methodology N=31 Methodology N=31 • Visit One Pre-Study Evaluation… Baseline examination and Visit 3… The right eye and left eye lens data collection were performed at 7:00 AM. Followed by diagnostic fitting of a 16.5 mm scleral lens with a target modalities (Scleral and SCL) were switched and apical clearance of 300 um. the study protocol repeated. • Visit Two Scleral Lens Dispensing Visit… Part 1… Pre lens application, Goldmann and Diaton IOP were taken, Optuvue OCT was performed. Part 2… At 7:30 AM randomized application of the scleral lens on one eye and a daily disposable Acuvue Oasys on the other. Immediately post-application, Diaton IOP and OptuVue OCT were performed. Part 3… Subjects were instructed to wear the lenses for 8 hours and return at 4:30 PM. Pre-lens removal IOP was measured with the Diaton and OptuVue OCT. Part 4… The lenses were then removed and immediately187 188 post-removal Diaton IOP and OptuVue OCT performed.

Study Cohort and Baseline Data BICOM INC. Diaton

189

There was an immediate increase in IOP of 5 mmHg in the eyes wearing the scleral lenses while the IOP There was an immediate increase in IOP of 5 mmHg in remained the same following the application of the SCLs. the eyes wearing the scleral lenses while the IOP remained the same following the application of the SCLs.

The increase in IOP remained constant throughout the period of lens wear for 8 hours and dropped back to the baseline measurement immediately post lens removal Impact of Scleral and Soft Lens Wear on IOP (bars with mean  84%CI) Average Contact lens and Anterior Eye 42 (2019) 104-110 increase in IOP 5.0 mmHg

21 subjects, age 24.7  4.1 y/o 15.8 18.0 mm scleral lens diameters of the same design, thickness and material. Conclusion: These results suggest that, as evaluated with a transpalpebral methodology, IOP during scleral lens wear may be increased in average by 5 mm Hg, 194 Effect -0.12 1.78 1.86 0.24 regardless of the lens diameter. Size

April 2019

51 years ago

SCL on one eye and a 15.8 mm scleral lens on the other Eight house of lens wear iCare tomometey immediately (within 5 seconds) post lens removal

HD Angio-Disc Peri-papillary RNFL Thickness The Radial Peripapillary RNFL image is defined to extend 4.5mm around the optic nerve head from the upper boundary of the Internal Limiting Membrane (bars with mean  84%CI) to the lower boundary of the Nerve Fiber Layer.

Internal Limiting Membrane

Nerve Fiber Layer

Pre Lens Post Lens Pre Lens Post Lens Application Application Removal Removal 197 Effect -0.07 -0.85 -0.739/16/2019 -0.12 Size Impact of Scleral Lens on Impact of Scleral Lens on Peripapillary RNFL Thickness Peripapillary RNFL Thickness (bars with mean  84%CI) (bars with mean  84%CI)

Pre Lens Post Lens Pre Lens Post Lens Pre Lens Post Lens Pre Lens Post Lens Application Application Removal Removal Application Application Removal Removal Effect -0.07 -0.85 -0.739/16/2019 -0.12 Effect -0.07 -0.85 -0.739/16/2019 -0.12 Size Size

Impact of Scleral Lens on Impact of Scleral Lens on Peripapillary RNFL Thickness Peripapillary RNFL Thickness (bars with mean  84%CI) (bars with mean  84%CI)

Impact of Scleral Lens on #1 Signal “Dampening” Secondary to Peripapillary RNFL Thickness Optical Index Changes During OCT (bars with mean  84%CI) Imaging

Scleral Lens Soft Lens

Pre Lens Post Lens Pre Lens Post Lens Application Application Removal Removal Effect -0.07 -0.85 -0.739/16/2019 -0.12 Size #2 Sympathetic Response Sympathetic Swelling Response of the Control Eye to Soft Lenses Sympathetic Swelling Response of the in the Other Eye Control Eye to Soft Lenses in the Other Eye Desmond Fonn, Renee du Toit, Trefford Simpson et al. Desmond Fonn, Renee du Toit, Trefford Simpson et al. Cornea, December 1999 Cornea, December 1999

DK 18 HEMA

DK 140 SiHy DK 18

No Lens Control No Lens Control DK 140

In this study 9 eyes (of 31 subjects) had an Subfoveal Choroidal Thickness increase in IOP of 10 mmHg or greater. Measurement with OCT TOOL (QUT) Change in Peripapillary RNFL Thickness 1. At the fovea (in subjects with increase in IOP >10mmHg) 2. At the optic disc 3. 3.25mm temporal to the fovea The decrease in Peripapillary RNFL (Green Line) RPE/Bruch’s Membrane Complex Thickness tended to 2 be more significant 3 in the subjects that 1 had increases in (Blue Line) Chorioial-Scleral Interface IOP of 10mmHg or greater during scleral lens wear. 9/16/2019 207 9/16/2019 208

In this 8 hour evaluation…there was Summary no statistical significant changes in… There was an immediate increase in IOP of 5 mmHg in the eyes wearing the scleral lenses. While the IOP remained the same following the • Inside disc radial application of the SCLs. peripapillary capillary density The increase in IOP remained constant throughout • Sub-foveal thickness the wearing period of 8 hours and dropped back to the baseline measurement immediately post lens • Ganglion cell complex thickness removal

9/16/2019 209 9/16/2019 210 Summary Journal of the American Medical Association July 2015 In this study, there was a statistically significant difference in Peripapillary RNFL Thinning in the eyes wearing the scleral lenses. This took place immediately following lens application and continued for the subsequent 8 hours of lens wear.

What are the long term ramifications of Optic Nerve Blood Profusion chronic exposure to a decrease in RNFL thickness ???

9/16/2019 211

In our 2018 study 11 of the 28 eyes had an Considerations increase in IOP of 10 mmHg or GREATER The decrease in Peripapillary RNFL Thickness begs the question….should we consider pre-fitting OCT Angiography for screening and monitoring scleral lens wearers long term retinal health???

In this study 9 eyes (of 31 subjects) had an increase in IOP of 10 mmHg or greater. 9/16/2019 214

Future Thoughts Future Thoughts • Our results are looking at the BEST CASE SENERIO. Our results are looking at the BEST CASE SENERIO. • These were young heathy eyes • These were young heathy eyes (average age 26.3 SD 2.5). (average age 26.3 SD 2.5). • Free of ocular and systemic disease. • Free of ocular and systemic disease. • With a limited wearing exposure of 8 hours. • With a limited wearing exposure of 8 hours. What will the results be in the aging eye??? With post-ocular surgery and/or active ocular pathology??? What are the long term IOP ramifications of wearing scleral lenses 12 to 16 hours a day???

215 Followed by post-removal and sleep when the216 IOP is potentially, its greatest??? Norman Bier Donald Ezekiel and Fenestrated 1943 Scleral Lenses First to patent the use of fenestrations in first glass and then PMMA scleral Contact Lenses

Donald Ezekiel and Fenestrated What is the best technique for Scleral Lenses managing pinguecula?

Smaller 14.5 mm Lens Design Scleral Lens Design

Diameter: 14.5 mm Fissure Size and Lens Diameter Left Eye 14.5 mm Scleral Severe Ocular Surface Disease

Scleral Lens Notching

Impingement of Pinguecula Large Diameter (19.5 mm) 3 mo Large Diameter (19.5 mm)

Tarsal Scaring and Lid Reactions... The Average Eyelid Are we missing something? •Blinks per Minute 12.55 •Blinks per Year 4,397,520 •Distance Traveled per Blink 8.5 mm •Distance Traveled per Year 46.5 miles

Excessive Right Axial Left Axial 300 um Apical 600um Clearance

OK? Not OK? Right Elevation Left Elevation Summary Controversies in Myopia Control “Is there anything that can be done to What we know in 2019 control my child’s increasing myopia???

For Centuries Scientists have Debated Dr. Monica Jong the Question of Whether Myopia is: Brien Holden Vision Institute FedOpto Medillian Columbia 2015 • Genetic, (Nature) - Ethnicity - Family inheritance

• Environment, (Nurture) - Molded by visual experience.

Myopia is the result of a complex interaction between…BOTH

Dr. Monica Jong Prevalence of Myopia East Asia Brien Holden Vision Institute Greater than 80% in Hong FedOpto Medillian Columbia 2015 Kong, Taiwan & Singapore 70% of today’s myopia is environmentally driven 30% is genetic. 5 to 7% in rural, uneducated groups What has changed in our children’s (Morgan 2006) environment in the past 50 years??? 5% in grandparents in Hong Kong (Lam 1994) 11 Suggest environmental factors rather than genetic factors are responsible for influx of myopia. Military Candidates Prevalence of Myopia and High Myopia • Jung et al (IOVS 2012) reported 96.5% prevalence in 5,060 Chinese University Students in of myopia in 19 year old South Korean military Shanghai candidates. Jing Sun, Jibo Zhou, Peiquan Zhao et.al. Investigative Ophthalmology November 2012 • Lee et al (IOVS 2013) reported 86.1% prevalence in 19 year old Taiwan military candidates. • Mean spherical equivalent refraction -4.12 D. • 95.5 % were myopic • Only 3.3 % were emmetropic

Prevalence of Myopia and High Myopia Increased Prevalence of Myopia in the in 5,060 Chinese University Students in US Between 1971-1972 and 1999 -2004 Shanghai Susan Vitale PhD, Robert Sperduto MD, Frederick Ferris MD Jing Sun, Jibo Zhou, Peiquan Zhao et.al. Archives of Ophthalmology Vol. 127 No. 12 December 2009 Investigative Ophthalmology November 2012 Ages 12 -54 • Mean spherical equivalent refraction 1971-1972 1999-2004 -4.12 D. 25.0% 41.6% • 95.5 % were myopic Myopic Myopic • Only 3.3 % were emmetropic • 19.5 % were highly myopic > -6.00 D. In 30 years a 62% increase in myopia

Changes in Myopia Prevalence Among First-Year University Students in 12 Years Today Jorge Jorge, Ana Braga, António Queirós Optometry and Vision Science July 2016 University of Minho, Portugal • A rise in myopia among first-year university students, from: 23.4% in 2002 41.3% in 2014 • A 76.5 % increase in 12 years. • The Investigators postulate “the increase in myopia prevalence...could be related to the lifestyle changes of the studied population.” Our Today Kid’s

Near Work and Myopia A Randomized Clinical Trial to Assess the Effect of a Dual Treatment on Myopia The possible role of near work in the genesis Progression: of myopia has been extensively explored The Cambridge Anti-Myopia Study. with inconclusive and conflicting results. Allen PM, Radhakrishnan H, Price H, et al. Ophthalmic Physiol Opt. 2013 May;33(3):267-76. • A double blind randomized control trial was conducted on 96 subjects.

• The 2 year study evaluated two different treatment modalities for improving accommodative functions. 1. Custom CL which control spherical aberration in an attempt to optimize static accommodation responses during near-work, 2. A vision-training program to improve accommodation.

• The research was unable to demonstrate that either of the two treatments (aimed at improving accommodative function) controlled myopia progression.

What Regulates Eye Growth??? Fundamental Across All Species

• In all species, (including Rodents humans) the two eyes Primates typically grow in a highly coordinated manner Cats towards the ideal optical Rabbits state, a process called “Emmetropization” Marsupials Birds • The process is regulated Fish by visual feedback. The Evolution of Man and Vision Survival 20/400 20/20 of the Species

The Evolution of Man and Vision Chronic Image Degradation Causes Myopia Wiesel & Raviola 1977 20/20 Monocularly lid-sutured Monkey Conditions that prevent the formation of a clear retinal image cause the eye to grow abnormally long and become myopic. Form-Deprivation Myopia

The potential for a clear retinal image is essential for normal refractive development.

Chronic Image Degradation Causes Myopia Form Deprivation Myopia Wiesel & Raviola 1977 If an eye that has from- Monocularly lid-sutured Monkey deprivation myopia is corrected with spectacle lenses no recovery takes place.

However, if the eye is allowed unrestricted (uncorrected) vision, the eye will recover through a: Visual Feedback Mechanism. Lens Compensation Studies Lens Compensation in Monkeys Optically imposed refractive errors produce Refractive Error is the Signal predictable refractive changes

Positive Lens Treatment Negative Lens Treatment The eye becomes more The eye becomes more Smith et.al. Univ. of Houston HYPEROPIC MYOPIC The signal for the eye to grow is DEFOCUS

What do the Lens Compensation Emmetropization in Monkeys Studies Tell Us??? • Optically imposed refractive errors produce surprisingly predictable refractive changes. • At a young age, the eye and visual system is extremely robust and able to be anatomically manipulated.

Emmetropization in Infants What and Where is the STOP signal for scleral growth?

Wallman and Winawer What Guides Refractive Error Outdoor Light….Luminance Development In Humans Hyperopic Myopia Control Defocus

Neurotransmitting Chemicals • Luminance

• Electromagnetic / Myopic Chromatic Signal Defocus • Diet

Optical Defocus Children who spend more time outdoors are less likely to become myopic.

Ambient Lighting Levels Light Exposure and Physical Activity in Myopic and Emmetropic Children 1,000 LUX Scott Read, Michal Collins, Stephen Vincent Queensland University of Technology Optometry and Vision Sciences 2014

50,000 lux

250 lux

Earl Smith

Light Exposure and Eye Growth in Average Axial Eye Growth… Childhood 18 Months Scott Read, Michael Collins & Steve Vincent Investigative Ophthalmology and Visual Science 2015 Average Daily Bright • 18 month prospective longitudinal study Low Daily Light Exposure Light Moderate Daily Light Exposure • 101 children ages 10 to 15 High Daily LightL Exposure Exposure (>1000 lux) • 41 myopes (SE -2.39 +- 1.51 D.) • Low Daily Light • 60 non-myopic (SE +0.35 +- 0.31 D.) • 56 min/day • Actiwatch 2 devices to measure ambient light • Moderate Daily Light exposure and physical activity. • 90 min/day • Worn for two - 14 day periods every six months. • High Daily Light • Axial length measurements every 6 months. 127 min/day Light Exposure and Physical Activity What Guides Refractive Error in Myopic and Emmetropic Children Development In Humans Hyperopic Scott Read, Michal Collins, Stephen Vincent Myopia Control Defocus Queensland Institute of Technology Optometry and Vision Sciences 2014 Neurotransmitting Chemicals No significant differences were found • Luminance between the average daily physical activity • Electromagnetic / levels of myopes vs emmetropes. Myopic Chromatic Signal Defocus • Diet

Optical Defocus

Myopia or hyperopia can be induced in chicks Childs Corrected Image and reversed by manipulation of the Myopic Eye Shell chromaticity of ambient light 1.25 D. WS Foulds, VA Barathi, CD Luu Singapore Eye Research, IOVS January 2014 • Baby chicks were raised in… red light…..(90% red and 10% green) Hyperopic blue light… (85% blue and 15% green) Defocus • Exposure time was 12 hour on-off cycle for 28 days. . • Red / Green light induced -2.83 D. +- 0.25 D … - Grow Signal • Blue / Green light induced +4.55 D. +- 0.21 D… - Stop Signal The refractive changes were axial, confirmed by ultrasound.

Red / Green What Guides Refractive Error

Grow ??? Development In Humans Hyperopic Myopia Control Defocus

Neurotransmitting Chemicals • Luminance

Myopic • Electromagnetic / Myopic Defocus Chromatic Signal Defocus • Diet

Optical Defocus

Blue / Green Relative stimulation of different cones Stop ??? The High Prevalence of Myopia is New. The Metabolic “Perfect Storm” What has changed in the past 30 years? • Spikes in glucose leads to spikes in insulin Metabolic Syndrome Epidemic in the blood (choroid). Metabolic syndrome is not a disease in itself. Instead, it's a group of risk factors: –High blood pressure • More insulin in the blood the stronger –High blood sugar signal to growth receptors in the sclera. –Unhealthy cholesterol levels • Suppressed outdoor light and excess –Abnormal fat levels insulin lead to a “perfect storm” for a growing eye. Diet Processed foods • i.e. China since the cultural revolution - Added sugars <5% myopia to 90%. Refined grains

What Guides Refractive Error Emmetropic Children Development In Humans Hyperopic Have Myopic Defocus Myopia Control Defocus

Neurotransmitting Chemicals • Luminance

• Electromagnetic / Myopic Chromatic Signal Defocus Myopic • Diet Defocus

Optical Defocus

Childs Corrected Image Prescribing Single Vision Lenses Myopic Eye Shell 1.25 D. • Childhood refractive errors are diagnosed at an earlier age: – School Screening Hyperopic – Optometric Defocus advertising . • We correct the child’s central vision HOWEVER spectacle lenses increase peripheral hyperopic defocus. Myopic Over the past 30 years billions of people worldwide have seen dramatic changes Defocus take place in their home, work and social environments. Indoor scenes with significant hyperopic defocus (red) and minimal myopic defocus (white).

Where, in the Visual Reduction Experiments System, is the SIGNAL for FDM does NOT require the visual signal to leave the eye. Axial eye growth continues the Eye to Grow? to take place despite surgical section or pharmacologic blockage – Visual cortex – Optic nerve – Ciliary nerve – Superior cervical ganglion Raviola & Rand 1985 Norton et al 1994

EYES STILL BECOME MYOPIC

The vision-dependent mechanisms that regulate eye growth are located IN THE EYE.

Axial Eye Growth ??? Conclusions, Smith et.al. #1 The fovea DOES NOT play the dominate role in A functioning fovea is not essential for refractive development. normal axial development.

Instead peripheral retinal image plays the MAJOR role in determining overall eye growth.

Earl Smith OD PhD University of Houston An Intact Fovea Is Not Essential for Conclusions Smith et.al. Normal Axial Eye Growth #2 An intact periphery is essential for normal axial development.

Smith et. al. Univ of Houston

Hemiretinal Form Deprivation: Evidence for No FDM Local Control of Eye Growth and Refractive Development in Infant Monkeys Control Control Earl L. Smith et al. Eye Eye Investigative Ophthalmology & Visual Sciences Vol50 No. 11 November 2009

FDM Left Eye

Study Control Study Control Eye Eye Eye Eye

Peripheral retinal receptors take in visual Myopic information and provide the signal for the eye to grow (or to stop growing) in a Defocus regionally selective fashion. Myopic Defocus

Study Control Eye Eye

The vision-dependent mechanisms that regulate eye growth are located IN THE EYE. Orthokeratoloy The Delivery of Optical Interventions Myopia Control Optics Rigid Contact Lenses • Orthokeratology • Front surface aspheric GP lens designs Multifocal SCL Soft Contact Lenses Myopic • Center distance multifocal designs Defocus • Extended depth of focus designs • Custom multifocal designs Spectacle Lenses Spectacle Lenses • Bi-focal lenses • Aspheric optic • Defocus Incorporated Multiple Segment (DIMS)

The Optics of How Does It Work ??? Orthokeratology

Minus Power Lens…Made of Epithelium

The Epithelium and OK Squeeze Film Force The unequal profile of the tear create a positive (push force) in the center of the cornea and a negative (suction/pull force) in the mid-periphery. Human Epithelium

Surface Cells

Wing Cells Thickness: 50 um Water Content: 75% Mid-Peripheral Central Cornea Mid-Peripheral Ref. Index: 1.382 Basal Cells Jennifer Choo OD PhD, Patrick Caroline, Dustin Harlin et.al.

Central Epithelium

Mid-Peripheral Epithelium 73.07

<3 microns Control Control Apical Thinning

37.49 38.59 34.75

Reverse Geometry GP Epithelial Cell Compression 10 minutes of Lens Wear

Normal

Compression Intercellular Fluid Transfer #1 Geographic Tissue Changes Gap Junctions: Small protein channels that permit cell contents to move from one cell to another.

Mid-peripheral Epithelium

Central Epithelium

#2 Mid-Peripheral Cornea Normal Cat Epithelium

Right Eye Left Eye

8 Hours 2 Weeks Control

Methods: Jennifer Choo et.al. Methods 15 Two-year old cats Overnight (16 hr) lens wear for all animals Randomly fitted with myopic OK and Alignment Histological analysis of corneas (5 regions) fitting GP lens 1 day, 1 week, 2 weeks, 4 weeks after Same diameter: 12.3 mm starting lens wear Same thickness: 0.16 mm

OK Lens Design Alignment Design Slit Lamp Examination Ortho K Eye Alignment Eye Corneal Topography To confirm appropriate corneal changes

Average Corneal Change -4.50 D.

Progressive Epithelial Changes Jennifer Choo OD PhD

1 2 3 4 5 1 2 3 4 5 Control

OK Eye Alignment Eye 2 3 4 1 Day 1 5

1 Week

4 Week

Jennifer Choo OD PhD

#1 Epithelial Cell Retention? #2 Peripheral Cell Migration? Axial Display Tangential Display

14 Days Post CRT

Increasing (+) Power Over the Pupil • Alterations in cell apoptosis • Decreased cell sloughing • Increased cell mitosis OK… How It Works -4.00 D. Change • Cellular compression with intercellular fluid transfer • Increased cell mitosis • Increased cell retention • Localized stromal remodeling ? • Multifactoral

Change in Elevation75 microns = -14 microns Pre-Fitting75 microns Corneal Shape

Post Fitting Corneal Shape -14 microns 50 microns 50 microns

Scanning Electron Microscopy Rx: -4.00 D.. Average Human Hair “75 microns thick” Right Eye 14 Dispensing Visit microns

-4.00 D. Correction

1000 X Right Eye 2 Week Visit Rule #1 In OK The distant -1.00 D. optical zone is only 1 to 2 mm in diameter

5.0 mm

+4.00 D. +4.00 D.. -7.00 D. -4.25 D.

Post -4.75 LASIK

-4.75 D

-4.75 D.

5.0 mm Pupil

Post OK -5.00 D.

-5.00 D

5.0 mm Pupil Rule #1 Rule #2 LASIK In OK The amount of plus 5.0 mm Pupil The distant power in the optical periphery -4.75 D.. zone is equals the only amount of 1 to 2 mm minus in power Ortho-K diameter corrected 5.0 mm Pupil 5.0 mm

+4.00 D. +4.00 D.. -5.00 D.

-4.25 D.

Foveal Orthok Effect: -1.00 D. Foveal Orthok Effect: -2.00 D.

+0.75 Add +1.50 Add -0.75 -0.50 -1.00 -2.00

Foveal Orthok Effect: -3.00 D. Foveal Orthok Effect: -4.00 D.

+3.00 Add +3.25 Add 0.00 -0.75

-3.00 -4.00 Foveal Orthok Effect: -5.00 D. Foveal Orthok Effect: -8.00 D.

+3.50 Add +8.00 Add

0.00 -1.50

-5.00 -8.00

Foveal Orthok Effect: -10.00 D. Foveal Orthok Effect: -3.00 D.

+10.00 Add +3.00 Add

0.00 0.00

-10.00 -3.00

Foveal Orthok Effect: -3.00 D. Foveal Orthok Effect: -3.00 D.

+2.25 Add +1.50 Add

-0.75 -1.50

-3.00 -3.00 If Plus (Myopic Defocus) is the Mechanism for Myopia Control

Myopic Myopia Control Design Adult Ortho-K Design Defocus

5.4 mm 6.8 mm

Chow 5 Year OK Axial Length Study

• Traditional 5 Curve OK Lens Design N = 165 • Aspheric 6 Curve OK Lens Design N = 129 • Historical Control CLEERE Study 2007

Traditional 5 Curve Design Aspheric 6 Curve OK Design 5.4 OZ N = 7 6.8 OZ N = 7

+3.55 D +-1.35 D. +3.04 D +2.36 D +-1.03 D. +-0.62 D.

+0.76 D +-0.65 D.

Study #1 Study # 2 1.8 5 year follow-up 5 year follow-up CLEERE Spectacle Study Data 1.6 1.55 165 Subjects 330 Eyes 129 Subjects 258 Eyes -4.50 D or -0.90 D. per year 1.4 Spherical 6.0 mm OZ, in Aspheric 5.4 mm OZ, in a 5 curve lens design a 6 curve lens design 1.2

1 Propensity Score Analysis Match eyes with similar baseline characteristics 0.8 Age, axial length, spherical equivalent power, keratometry, eccentricity, corneal diameter pupil size and central corneal thickness 0.6

5 Year Axial Axial ChangeLength From BL Year 5 0.4

0.2

0 Asian <-2.00 -3 -4 -5 -6 -7 191 Eyes 191 Eyes Myopes Spherical 6.0 mm OZ Lens Design 1.8 1.665 0.00 CLEERE Spectacle Study Data 1.6 1.55 Study #1 Spherical 6.0 OZ Design 1.4 1.325

1.2

1 0.883

0.8 0.615 0.6 0.482

5 Year Axial Axial ChangeLength From BL Year 5 0.4 0.255 0.2

6.0 mm OZ 0 Asian <-2.00 -3 -4 -5 -6 -7 Myopes

Study #1 Myopia Control Studies with Ortho-K 5 year follow-up 165 Subjects 330 Eyes Average 48.8 % Spherical 6.0 mm OZ, in a 5 curve lens design

Propensity Analysis

191 Eyes

Good Myopia Control N = 112 Small changes in axial elongation

Poor Myopia Control N = 79 Large changes in axial elongation

Chow Study 5 year Axial Length 191 Eyes 6.0 mm OZ N = 191 eyes

A post hoc analysis was used to determine if we could identify any baseline characteristics that might predict the difference in axial elongation within the Spherical OZ group. Good Myopia Control Group baseline characteristics:

• Longer baseline axial lengths (more myopic) 25.1 mm vs 23.7 mm = approx. -3.75 D. • Smaller corneas (11.2 vs 11.4) • Steeper corneas (Flat K. 44.17 vs 42.28) • Higher corneal eccentricities (0.54 vs 0.41) 191 Eyes -1.00 Rx Change

• Longer Baseline Axial Lengths (more myopic 25.1 mm vs 23.7 mm = approx. -3.75 D. • Smaller corneas (11.2 vs 11.4) • Steeper corneas (Flat K. 44.17 vs 42.28) • Higher corneal eccentricities (0.54 vs 0.41)

-4.00 Rx Change Foveal Orthok Effect: -1.00D

+0.75 Add -0.25

-1.00

Foveal Orthok Effect: -4.00D Comparison of Rx Changes

+0.75 Add -1.00 Rx Change

+3.25 Add -4.00 Rx +3.25 Add Change -0.75

-4.00 Study #1 Study # 2 Orthok Tear Layer Profile 5 year follow-up 5 year follow-up 165 Subjects 330 Eyes 129 Subjects 258 Eyes Spherical 6.0 mm OZ, in Aspheric 5.4 mm OZ, in -1.00 Rx a 5 curve lens design a 6 curve lens design Change Propensity Score Analysis

191 Eyes 191 Eyes -4.00 Rx Change Good Myopia Control Small changes in axial elongation

Poor Myopia Control Large changes in axial elongation

Aspherical 5.4 mm OZ Lens Design Spherical0.00 6.0 mm OZ Lens Design

5 um

Aspherical 5.4 mm OZ Lens Design

5 um

5.4 mm OZ

1.8 1.8 CLEERE Spectacle Study Data CLEERE Spectacle Study Data 1.6 1.55 1.6 Study #2 Aspheric 5.4 OZ Design Study #1 Spherical 6.0 OZ Design 1.4 1.4 Study #2 Aspheric 5.4 OZ Design 1.2 1.2

1 1

0.8 0.8

0.6 0.525 0.6 0.419 0.438

5 Year Axial Axial ChangeLength From BL Year 5 0.4 0.336 0.331 Axial ChangeLength From BL Year 5 0.4 0.23 0.2 0.2

0 0 Asian <-2.00 -3 -4 -5 -6 -7 Asian <-2.00 -3 -4 -5 -6 -7 Myopes Myopes Animal Study’s to Chow Study 5 year Axial Length 5.4 mm OZ Human Application N = 191 eyes

“As the proportion of retinal area receiving myopic Graded Competing Regional Myopic and defocus increased…the degree of myopic eye Hyperopic Defocus Produces Summated RESULTS: growth was reduced”. Emmetropization Set Points in Chicks Correction Ratio VCD Dennis Y. Tse and Chi-ho To IOVS 2011 -8.90 D 0/100 +592 Hyperopic Center for Myopia Research, School of Optometry, Hong Kong -2.40 D 25/75 +230 Defocus Polytechnic University +1.60 D 33/67 -105 +5.90 D 40/60 -253 Myopic Defocus Investigated the axial +7.60 D 50/50 -447 response of the eye +10.40 D 100/0 -515 when a specific proportion of the retina was exposed to myopic Myopic Defocus Hyperopic Defocus defocus while the remainder was exposed to (competing) hyperopic defocus.

Axial Eye Growth and Refractive Error Development Results and Conclusions Can be Modified By Exposing the Peripheral Retina Longer 5 to Relative Myopic and Hyperopic Defocus 4 Vitreous Plus Chamber Refraction Depth 30 Benavente-Perez, A, Nour, A., Troilo, D. 1 Primates SUNY College of Optometry 2 Investagative Ophthalmology , September 2014 3 4 3 2 5 1 Shorter Minus 1. Plano, Center Distance 1.5 OZ (+5.00 D. Add) 2 “Eye growth and refractive state can be manipulated by altering 2. Plano, Center Distance 3.0 OZ (+5.00 D. Add) 3 peripheral retinal defocus.” “Imposing peripheral MINUS produces axial myopia”. 3. Plano, Center Distance 3.0 OZ (-5.00 D. Add) 4 “Imposing peripheral PLUS produces axial hyperopia”.

4. Total correction +5.00 D. 1 “The effects are smaller than using single vision CL’s that impose full 5. Total correction -5.00 D. 5 field defocus. This supports the use of multifocal CL’s as an effective treatment for myopia control”. Axial Power Display -5.00 D. Change

Myopia Control Design Adult Ortho-K Design

Munnerlyn Formula Munnerlyn Formula Depth of the Treatment Zone Equals Depth of the Treatment Zone Equals Optical Zone Diameter ² X Refractive Error Optical Zone Diameter ² X Refractive Error 3 3 Treatment Zone Diameter = 5.0 mm Treatment Zone Diameter = 2.0 mm OZ Squared 5.0 x 5.0 = 25 OZ Squared 2.0 x 2.0 = 4.0 Times the Refractive Error = -5.00 D. Times the Refractive Error = -5.00 D. 125 20 Divided by 3 = 42 Divided by 3 = 7 Tissue Change = 42 microns Tissue Change = 7 microns

Munnerlyn’s Formula -5.00D. Dedicated Myopia Control Design Treatment Amount of 6.5mm OZ Zone Tissue Change 1.0 mm 2 microns 2.0 mm 7 microns 3.0 mm 15 microns 4.0 mm 27 microns 5.0 mm 42 microns 5.5mm OZ 6.0 mm 60 microns Anterior Aspheric Lens Diameter Prevalence of Myopia and High Myopia 10.5 to 11.0mm in 5,060 Chinese University Students in Back Surface Toric… Shanghai Jing Sun, Jibo Zhou, Peiquan Zhao et.al. Investigative Ophthalmology November 2012

• Mean spherical equivalent refraction -4.12 D. • 95.5 % were myopic • Only 3.3 % were emmetropic

Prevalence of Myopia and High Myopia CFDA Approved Myopia in 5,060 Chinese University Students in Control in China Shanghai • Overnight orthokeratology Jing Sun, Jibo Zhou, Peiquan Zhao et.al. is approved in children for Investigative Ophthalmology November 2012 Myopia Control from….. -0.50 D to -5.00 D. • Mean spherical equivalent refraction -4.12 D. • Soft contact lenses • 95.5 % were myopic (multifocal SCL’s) can not • Only 3.3 % were emmetropic be fitted to children or • 19.5 % were highly myopic young adults under the age of 18. > -6.00 D. Therefore, GP multifocal lenses design have found a place in the Chinese culture.

Optical Interventions Peripheral Plus Rigid Contact Lenses

Distance • Orthokeratology Minus • Front surface aspheric GP lens designs Soft Contact Lenses • Center distance multifocal designs • Extended depth of focus designs Peripheral Peripheral • Custom multifocal designs Plus Anterior Surface Optics Plus Spectacle Lenses • Bi-focal lenses Distance Minus • Aspheric optic • Defocus Incorporated Multiple Segment (DIMS) The DEFOCUS THEORY…. With (-) Lenses GREATER (+) Power in the Periphery Conflicting Retinal Signals Theory

Myopic PLUS PLUS PLUS PLUS Defocus . MINUS

MINUS MINUS

Center Near MF Designs for MC

“Any Amount Exposing the eye to of Plus conflicting signals… Anywhere in Myopic defocus (good the Eye” stuff) and hyperopic Dr. Thomas Aller defocus (bad stuff).

Center Distance Multifocal Soft Lens Designs Acuvue Oasys for Presbyopia Cooper Vision Cooper Vision J&J MiSight Proclear MF Acuvue Oasys Distance Powers: Biofinity MF -0.50 to -9.00 D. Near Powers: D D D Low = +0.75 - +1.25 Medium: +1.50 - +1.75 High: +2.00 - +2.50 DK = 103 Design 8.4 / 14.3 Replacement: 2 wk

Pete Kollbaum Acuvue Oasys +2.50 MF MAX Cooper Vision Biofinity Multifocal +1.504.00-3.00 +1.50 ADD Distance Powers: 1.79 2.00 1.36 1.4 mm -0.50 to -10.00 D. 0.73 0.15 0.21 +1.64 D. Near Powers: +1.00, +1.50, 0.00 -1.27 +2.00, and +2.50 in both D -1.73 -2.05 and N lens designs. -2.00 -2.77 -2.76 +1.50 D. DK = 128 Design 8.6 / 14.0 -4.27 -4.00 -4.70 -5.10 Dioptric Power -5.70 -5.78 +1.43 D -6.00 -7.66 -7.19 -8.00 -8.42 -8.68 -8.80 +1.49 D. Hemi Chord -10.00 0.00 0.50 1.00 1.50 2.00 2.50 3.00 Average plano -3.00 -6.00 -9.00 +1.51 D.

CV Biofinity +2.50 MF MAX Cooper 4.00 ADD +1.57 -3.00 +1.57 2.0 mm Vision, 3.00 2.70 2.09 +2.31 D. 2.00 MiSight 0.68 1.00 0.39 Dual Focus 0.00 -1.11 -1.01 -1.01 +1.57 D. Design -1.00

-2.00 -2.58 -2.44

Dioptric Power -3.00

-4.00 -4.44 -5.00 +1.22 D. -5.00 -5.66 -5.52 D N D N -6.00 Hemi Chord -7.00 Average 0.00 0.50 1.00 1.50 2.00 2.50 3.00 +1.70 D. plano -3.00 -6.00 -9.00

Cooper Vision MiSight MAX Visioneering Technologies, Inc. +1.902.00 -3.00 +1.90 ADD NaturalVue 1-Day Multifocal 2.0 mm 1.00 1.42

0.00 -0.54 0.40 -0.41 Extended Depth of Focus Design -0.59 -0.73 +1.96 D. -1.00 -0.74

-2.00 -2.63 +1.90 D. -2.75 -2.86 -3.00 -3.65

-4.00 Dioptric Power -3.68

-5.53 + 1.88 D. -5.00 -5.59 -5.92 -6.00

-7.00 0.00 0.50 1.00 1.50 2.00 2.50 3.00 Average

-0.50 -3.00 -6.00 +1.91 D. NaturalVue MF MAX NaturalVue -3.00 D. +2.60 -3.00 +2.60 ADD 4.00 2.75 mm 2.39 2.00 1.20 (5.5 mm) 0.53 -0.08 0.06 -0.32 +2.47 D. 0.00 -1.65 -2.00 -2.92 -2.88 -2.96 +2.60 D. -4.07 -4.00 -5.19 -6.31 -6.22 -6.00 -6.83 -6.71 +2.24 D. +2.50 D. +2.50 D. -8.05 -8.00 -8.92 -9.57

Dioptric Dioptric Power -10.53 -10.21 +2.74 D. -10.00 -11.33 -3.00 D. -12.56 -12.60 -12.00 +2.03 D. Chord 2.0 mm -14.20 -14.00 Hemi Chord Average -16.00 0.00 0.50 1.00 1.50 2.00 2.50 3.00 +2.41 D. Chord of max. add 5.5 mm -4.50 D. -4.50 D. plano -3.00 -6.00 -9.00 -12.00

All Lenses Center Distance -3.00 D. All Lenses Center Distance -3.00 D. With Maximum Add Powers With Maximum Add Powers Acuvue Oasys BioFinity Acuvue Oasys BioFinity Max Add @ 2.8 Max Add @ 4.0 mm Max Add @ 2.8 Max Add @ 4.0 mm

+1.50 D. +1.57 D.

MiSight NaturalVue MiSight NaturalVue Max Add @ 4.0 mm Max Add @ 5.5 mm Max Add @ 4.0 mm Max Add @ 5.5 mm

+1.90 D. +2.60 D.

Concentration of Add Power Concentric Aspheric Addition Design

N D N N D N

Physical area of the retina involved in the peripheral defocus process Concentric Linear Addition Design Concentric Constant Addition Design

N D D N N D N D N N N

Art Tung’s OK Soft Lens Design Optical Interventions Rigid Contact Lenses • Orthokeratology • Front surface aspheric GP lens designs Soft Contact Lenses • Center distance multifocal designs • Extended depth of focus designs • Custom multifocal designs Spectacle Lenses • Bi-focal lenses • Aspheric optic • Defocus Incorporated Multiple Segment (DIMS)

Prescribing Single Vision Lenses

2010 • Childhood refractive errors are diagnosed at Hyperopic Defocus an earlier age: “In conclusion, our – School Screening results provide – Optometric evidence that advertising correction of single • We correct the vision spectacle lenses child’s central induced absolute vision HOWEVER hyperopic defocus on spectacle lenses the retinal periphery of increase peripheral low and moderate hyperopic defocus. myopic eyes” Zeiss Essilor MyoVision Myopilux spectacle spectacle lenses lenses for for myopia myopia control control in in children children 3 Myopia Control Designs

The Hoya DIMS Spectacle Lens The Study and Results • A randomised double-blinded clinical trial was conducted from August 2014 • Comprised of a central optical zone for correcting the myopia to July 2017. and astigmatism. • The study comprised 160 Chinese children aged 8 to 13, with myopia from 1 • Surrounded by multi-segments (micro lenses) of constant to 5 diopters (D), and astigmatism and anisometropia of 1.50 D. or less myopic defocus extending to mid-periphery of the lens. completed. • 79 children were randomly assigned to wear the DIMS Spectacle Lenses (treatment group) and 81 single vision spectacle lenses (control group). • Two year myopic progression: • Treatment group was 0.38 D. • The control group was 0.93 D. • Two year increase in axial length: • Treatment group was 0.21 mm • Control group was 0.53mm. It provides myopic defocus simultaneously for the wearer at all Children wearing the DIMS Spectacle Lenses had 59% less viewing distances. myopic progression and 60% less axial elongation.

Atom 2 Study Atropine and Myopia Control Chia, et.al. Ophthalmology 2011 Atropine for the Treatment of Childhood Myopia Atropine Control % Change 400 children ages 6 – 12 with greater than -2.50 D. Group Group Annual RE Myopia % Progression ATOM 1 Progression Reduction Yen 0.22 0.91 76% Placebo -1.20 D. Shih 0.04 1.06 96% Atropine 1% -0.28 D. 77%

Chou 0.14 0.60 77% ATOM 2 Atropine .5% 1% (2 x less concentration) -0.30 D. 75% Atropine .1% Atropine (10 x less concentration) -0.38 D. 68% Atropine .01% (100 x less concentration) -0.49 D. 59% Changes in Axial Length and Atom 1 and Atom 2, Axial Length Spherical Equivalent Over 2 Years

Jeffery Cooper OD

Ophthalmology 2018 Change in Placebo Axial Length 0.01% 0.025%

0.05%

Conclusions: The 0.05%, 0.25% and 0.01% atropine eye drops reduced myopia progression along a concentration-dependent response. All concentrations were well tolerated without an adverse effect on vision or quality of life. Of the 3 concentrations used… 0.05% atropine was most effective in controlling axial length elongation over a period of one year.

Summary Optical Interventions “Is there anything that can be done to Rigid Contact Lenses control my child’s increasing myopia??? • Orthokeratology • Front surface aspheric GP lens designs Soft Contact Lenses • Center distance multifocal designs • Extended depth of focus designs • Custom multifocal designs Spectacle Lenses • Bi-focal lenses • Aspheric optic • Defocus Incorporated Multiple Segment (DIMS)