Curvature versus Elevation · 20.0 mm Chord Low Corneal Astigmatism < 0.75 D High Corneal...

Controversies in Scleral Lenses

2019

Normal Keratoconus PMD Keratoglobus

Curvature versus Elevation

Axial Display

Power Map

Elevation Map

Height Map

Axial Display Elevation DisplayPatient CB Moderate KC

Axial Display Map

+180um

-110um

+180

-110

290 microns

Elevation Display

Map

-276um

Depression

Below the

Sphere

+379um

Elevation

Above the

Sphere

+379

- 276

655

Micron

Height

Differential

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.

N = 87 Patients

127 CL Fits

The Re-Birth of Scleral Lenses Glass Scleral Lenses1887

Molding Glass Scleral Lenses

Average

8.5

High DK Scleral Materials• Menicon Z Dk = 163

• 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

Traditional Corneal / Scleral

Shape

Scleral Shape

New Understandings

Cone Angle Circa 1948

Klaus Pfortner

Argentina

Scleral Lens Fitting Objectives

1. Central Vault Zone

(250 to 400 microns)

2. Peripheral Lift Zone

3. Limbal Lift Zone

4. Scleral Landing

Zone

12 34 23 4

Anatomy of a Scleral Lens

Scleral

Lens

Indications

Ocular Surface Disease

Corneal Irregularity Ectasia/Scar/Post Surgery

Scleral Lens Indications

Irregular Astigmatism

• Keratoconus

• 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

Scleral Lenses

for Ocular

Surface Disease

Pathologic Ocular Surface Disease

• Chemical Burns

• Ocular Pemphigoid

• 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 20/4006 months

Post Scleral

Lens 20/25

Ocular Surface Disease…

Pre-Scleral 2 Months Post

Scleral

Scleral Lens

Fitting bySagittal Height

Low Sag Eyes and

Normal Eyes

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

9 Lens Ampleye

Diagnostic Set

Markings on Ampleye Diagnostic

and Patient Lenses

Rotation Markings Along the Flat Meridian

Diadmostic Fitting….

Filamentary Keratitis

Initial diagnostic lens selection is based on

corneal height/optical condition.

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 PurilensOTC

LacriPure Saline from MeniconApplication Bubble

Re-Application Central Vault Zone250 to 400 microns of Apical Clearance

Scleral Lens Setteling

8 hour

Lens

SettlingBaseline

400 um

8 Hours

270 um (130 um)

30 mts.

1 hr.

340 um (60 um)

2 hr.

4 hr.

6 hr.

Approx.

130 um

White Light Cobalt Light

Limbus

Inadequate Peripheral Corneal Clearance

Appropriate Peripheral Corneal Clearance

Dispensing 4,200

Dispensing

4,000 um

Post 4 Hours

Peripheral Lift ZonePLZ Changes

The change in sag

between the Standard

and +5 PLZ is:

125 microns.

Peripheral

Lift Zone +5 increase = 125 um

Light

Peripheral

Bearing

Adequate Corneal and

Limbal Clearance

Inadequate Limbal Clearance

Over-Refraction Patient: TW KATT for KC

Axial Map

TW Elevation Map Initial Diagnostic Lens Selection

TW Right Eye

Sag = 4,400

Inadequate

Apical Clearance

Appropriate

Apical Clearance

Low Sag Eyes and

Normal Eyes

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

9 Lens Ampleye

Diagnostic Set

TW Right Eye

Sag = 5,000

Pellucid Marginal DegenerationRight Eye

Initial Diagnostic Lens SelectionRight Eye

Peripheral Lift ZonePLZ Changes

The change in sag

between the Standard

and a +5 PLZ is

125 microns.

Right Eye

KC With Intacs

Ten Days Post-Surgery

One Week After Scleral Lens Wear

Normal Eye

Sag = 3,735 um

Budging Graft

Sag = 5,780 um

Axial Display Map

Elevation Display Map

193 um

Elevation

292 um

Depression

Total Height Differential

485 microns

Diagnostic Lens Final Lens

Increase PLZ

+10 = 250 microns

Precision Ocular Metrology sMap3D Eaglet ESP Eye Surface Profiler

150 un

Differential between

steep and flat meridians

Temporal Nasal

LR MR

Temporal Nasal

OCT

Average Sagittal Height

and Scleral Lens Position

Spherical

Corneal

Zone

Toric Scleral Lens Design

Spherical

9.5 mm

Optical Zone

Highest

Scleral

Meridian

Lowest

Scleral

Meridian



Scleral Landing Zone

Scleral Landing Zone

Conjunctivial “Compression” Summary of Fitting Techniques

Scleral

Lenses

2016

Corneal Astigmatism vs Scleral

AstigmatismBeth Kinoshita Sheila Morrison

The sMap 3D was used to measured the

position of 20 subjects

SCLERL astigmatism.

All 20 subjects had with-the-ruleCORNEAL astigmatism.

Medmont Topography

16.0 mm Chord

16.0 mm Chord

17.5 mm Scleral Lens

Visionary sMap3D 20.0 mm Chord

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

• 7 had Asymmetric scleral toricity at a 15.0 mm

chord.

• 4 had Against the rule scleral toricity at a 15.0

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.

The sMap 3D was used to measured the

position of 20 subjects SCLERL astigmatism.

All 20 subjects had with-the-rule

CORNEAL astigmatism.

Spherical

9.5 mm

Optical Zone

Highest

Scleral

Meridian

Lowest

Scleral

Meridian

Toric Scleral Design

Spherical

9.5 mm

Optical Zone

Highest

Scleral

Meridian

Lowest

Scleral

Meridian

Toric Scleral Design Difficulties with Scleral Lenses

A B C

Right Eye Left Eye

Uncomfortable Uncomfortable

Right Eye Left Eye

Uncomfortable Comfortable

Right Eye Left Eye

Uncomfortable Comfortable

When Things Go

Wrong With

Scleral Lenses

Is the oxygen permeability of our

current GP lens materials adequate

for today’s scleral lens designs?

Pacific University Scleral Lens Corneal Swelling Project

Contamac Comfort DK 65

Contamac Extra DK 100

Contamac Extreme DK 125

5.54

4.484.18

3.56 3.56 3.41 3.31 3.25

1.781.36

0.38

-1.25

-2

-1

0

1

2

3

4

5

6

1 2 3 4 5 6 7 8 9 10 11 12

Individual Overnight Swelling Average = 2.85

12 Subjects Overnight Corneal Swelling

No Contact Lens Wear

Average

Corneal Swelling

2.8%

Normal Non-Lens-Wear Corneal

Swelling = 2.80%

Contamac Comfort DK 65 N = 16

Average Swelling in Percentage: 2.27%

Contamac Extra DK 100 N = 16


Contamac Extreme DK 125 N = 16


Clear PKP with Endothelial

Dysfunction

Normal 18 y/o

3,065 cells/mm278 y/o Post PKP

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 /

Extended Wear Basis???

Primary reasons:

• to provide protection

for persistent corneal

erosions

• to promote more

rapid wound healing.

Is there adequate oxygen permeability

through scleral lenses in the closed eye

environment ???

Do Scleral Lenses Provide Adequate

Oxygen Permeability for Overnight

Lens Wear? Paul Nefedov, Sheila Morrison OD, MS, Patrick Caroline, Randy Kojima and Beth Kinoshita OD

• Ten normal eye subjects participated in this two part

study.

• In Phase 1 baseline overnight corneal swelling for each

subject with no CL wear.

• 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

overnight on the right eye for 8 hours.

• Corneal thickness was measured immediately upon

awakening, and the percent of corneal swelling was

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

application solution PF Unisol

saline, PF inhalation saline or

PF artificial tear....other?

pH = 7

pH = 5

AMPLEYE 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 PurilensPlus Ultra PF Saline from Purilens OTC

LacriPure Saline from Menicon

Right Eye

Left Eye

Boston

Conditioning

Solution

for Lens

Application

What are the mechanisms for

“Epithelial Bogging” and should we

be concerned about it?

Epithelial

“Bogging”

1 Week Post-Fitting

2 Months Post-Fitting

Post Lens Tear Film

“Fogging”

Baseline OCT

4h post application

8h post application

Cornea

Tear Film

Scleral Lens

Tear Film “Fogging”

The Human Tear FilmMucous Layer

• Mucopolysaccharide

• glycoproteins

• N-Ac-glucosamines

• sialic acid

• fucose

• mannose

• Galactose

Aqueous Layer

• water 98%

• solids 2%

• Inorganics

• cations

• Anions

• Organics

• glucose

• Urea

Proteins*• Lysozyme

• Lipocalin

• IgA

• Lactoferrin

Lipid Layer

• Wax esters

• Cholesterol esters

• Fatty acids

• Free cholesterol

• Triacylglycerol

(TAG)

• OAHFA

*Mann and Tighe 2007

Tear Reservoir Proteins

0

200

400

600

800

1000

1200

1400

1600

Lacto

tran

sfer

rin

Lipoca

lin -1

Lyso

zym

e C

Ser

um a

lbum

in p

recu

rsor

Pro

lact

in in

ducible

pro

tein

Poly

mer

ic ig

G rec

epto

r

Ig -

alpha

1 ch

ain C

reg

ion

IG k

appa

chai

r C re

gion

Mam

mag

lobin

- B

Zinc-

alpha

- 2 -

glyco

prote

in

# o

f p

ep

tid

es p

er

12

.5u

l s

am

ple

Proteins

Turbid Clear

Maria Walker MS OD

Sheila Morrison

The Human Tear FilmMucous Layer

• Mucopolysaccharide

• glycoproteins

• N-Ac-glucosamines

• sialic acid

• fucose

• mannose

• Galactose

Aqueous Layer

• water 98%

• solids 2%

• Inorganics

• cations

• Anions

• Organics

• glucose

• Urea

Proteins*

• Lysozyme

• Lipocalin

• IgA

• Lactoferrin

Lipid Layer

• Wax esters

• Cholesterol esters

• Fatty acids

• Free cholesterol

• Triacylglycerol

(TAG)

• OAHFA

*Mann and Tighe 2007

Oil-Red-O Lipid StainIn a Non-“Cloudy” Patient

Oil-Red-O Lipid Stain

In a “Cloudy” Patient

0

50

100

150

200

250

300

350

400

C1 C2 C3 C4 F1 F2 F3 F4 F5

Ch

ole

ste

rol

(ug

/ml)

Tear Reservoir Samples

Fog Samples

Clear Samples

Tear Reservoir Lipids: Cholesterol Tear Reservoir Lipids: Cholesterol

CLEAR Fogged

Peripheral Corneal/Limbal Landing

DesignManaging “Fogging”

What is the best lens care system

for cleaning and disinfecting scleral

lenses?

Hydrogen Peroxide

Lens Disinfection

Lens Storage Cases

ClearCare Case Dalsey Adaptives

8.0 to 18.0 mm 8.0 to 24.0 mm

Dalsey Adaptives LLC

Springfield, Massachusetts

Dalsey Adaptives LLC

Springfield, Massachusetts

The EZ Eye Scleral Lens Applicator(Q-Case Inc.)

Application Bubbles....

Why do we see so much initial non-

wetting of these lenses and how do

we best manage it?

How do we best manage surface

debris and deposits?

Should scleral lenses be Plasma

Treated and “wet shipped”?

When is it appropriate to place the

patient on the “Progent” lens

cleaning regime?

Surface

Deposits

Non-Wetting

Pre-Cleaning

Post-Cleaning

Is there tear exchange beneath well

fitted scleral lenses?

Tear Exchange Study #1

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

time point to monitor lens settling.

Subject SM

Right Eye Left EyeBaseline

30 mts.

1 hr.

2 hr.

4 hr.

6 hr

8 hr.

SM Right Eye

Baseline Post 8 hrs.

Apical Clearance Apical Clearance420 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

called conjunctival prolapes?Inferior

Conjunctival Prolapse

Superior Prolapes Conjunctival Prolapse

Transient

Conjunctival Prolapse

Axial Display Elevation Display

Conjunctival

Prolapse

Axial Display Elevation Display

Conjunctival

Prolapse

Conjunctival

Prolapse

Is it OK ??? Controversies Scleral Lenses

Conjunctival

Prolapse…Suction???

Subject #1 Subject #2 Subject #3

Due to normal lens settling into the soft tissue of the bulbar

conjunctiva, the volume of fluid in the tear reservoir decreases from

baseline to 8 hrs. This must be taken into consideration when

subjectively comparing baseline images to 8 hr. images.

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

Results of Study #2

IntroductionDuring corneal GP lens wear, 20% of the post lens tear volume is

exchanged with each blink. With soft contact lenses, the exchange is

less than 1%. Therefore, a lingering question remains, “how much

tear exchange takes place beneath modern scleral lenses?” To

address this question we performed two pilot studies.

In Study #2, scleral lenses filled with clear PF saline were place onto one eye of three

subjects and photographed with white and cobalt blue light. Following 30 minutes of

lens “settling”, PF fluorescein drops were instilled onto the superior bulbar conjunctiva

every 20 minutes for 8 hours (total 23 drops). At 8 hours the amount of fluorescein

present beneath the lens was photographed and subjectively compared to the baseline

images. Anterior segment OCT was performed at baseline and at 8 hours to monitor

lens settling.

Study #2

The average amount of 8 hour lens settling in the 3 subjects was 123 um. The post 8 hr.

white light images showed no evidence of conjunctival compression or impingement.

Subjective observation of the cobalt blue images showed little or no fluorescein beneath

the lens following 8 hours of lens wear.

❖ Based on our fluorescein studies, it would appear that minimal tear

exchange takes place over 8 hours.

❖ Molecular analysis of the post lens fluid will be needed to quantify

tear exchange beneath a scleral lens, and clarify the compositional

changes of the solution during lens wear.

❖ Characterization of tear exchange beneath these lenses has

important implications for solution development, as well as the

advancement of medical therapies using scleral lenses.

Conclusions

In Study #1, a scleral lens was placed on the right eye of 3 subjects,

using fluorescein dissolved into PF saline as the application solution.

Subjects wore the lens for 8 hours and photography was performed

at 30 min, 1, 2, 4, 6, and 8 hrs. Anterior segment OCT was performed

at each time point to monitor lens settling.

Subject #1 Post 8 hr. Subject #2 Post 8 hr. Subject #3 Post 8 hr.

Subject #1 AM Dispense Subject #2 AM Dispense Subject #3 AM Dispense

Study #1

The average amount of 8 hour lens settling in the 3 subjects was 133

um. Subjective observation of the fluorescein showed little or no

fluorescein exchange throughout the eight hour period.

Discussion

Results of Study #1

Fluorescein is clinically accepted to characterize the volume of tear

beneath rigid contact lenses. Both of our pilot studies showed via the

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

molecules have more difficulty passing into and out of the tear

reservoir as compared to the aqueous component and smaller

particles in solution and tears.

Baseline 1 hr. 8 hrs.

October 2012

Dr. Peter Wilcox’s

Practice in

Virginia

Terrien’s Marginal Degeneration

Scleral Lens 16.5 mm Material DK = 100

Without Scleral Lens With Scleral Lens

Angle = 28.6 Degrees Angle = 19.9 Degrees

IOP = 20 mmHg IOP = 30 mmHg

IOP Measurement with Diaton

179

Does Scleral Lens Wear Influence

Intraocular Pressure?Emily Korszen OD

Pacific University College of Optometry

GSLS January 2017

Does IOP Increase During Scleral

Lens Wear?Steven Turpin OD and Kennedy Antoniuk

GSLS January 2018

No Lens Wear

AM and PM

Scleral Lenses in

Place for 8 Hours

5 mmHg

Increase

in IOP

7 mmHg

Increase

in IOP

5 mmHg

Increase

in IOP

11 of the 28 had increases in IOP

of 10 mmHg or GREATER

186

Impact of Scleral Lens Wear on

Intraocular Pressure and Posterior

Ocular PerfusionPabita Dhungel

PUCO, MSc Vision Science

Methodology N=31

187

• Visit One Pre-Study Evaluation… Baseline examination and

data collection were performed at 7:00 AM. Followed by

diagnostic fitting of a 16.5 mm scleral lens with a target

apical clearance of 300 um.

• 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 immediately

post-removal Diaton IOP and OptuVue OCT performed.

Methodology N=31

188

Visit 3… The right eye and left eye lens

modalities (Scleral and SCL) were switched and

the study protocol repeated.

189

Study Cohort and Baseline Data BICOM INC. Diaton

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 application of the SCLs.

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 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

increase in

IOP 5.0

mmHg

Effect -0.12 1.78 1.86 0.24

Size

Contact lens and Anterior Eye 42 (2019) 104-110

194

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,

regardless of the lens diameter.

April 2019

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

51 years ago

HD Angio-Disc

197

The Radial Peripapillary RNFL image is defined to extend

from the upper boundary of the Internal Limiting Membrane

to the lower boundary of the Nerve Fiber Layer.

Internal Limiting Membrane

Nerve Fiber Layer

9/16/2019

Pre Lens Post Lens Pre Lens Post Lens

Application Application Removal Removal

Effect -0.07 -0.85 -0.73 -0.12

Size

Peri-papillary RNFL Thickness 4.5mm around the optic nerve head

(bars with mean 84%CI)

Impact of Scleral Lens on

Peripapillary RNFL Thickness(bars with mean 84%CI)

9/16/2019



Effect -0.07 -0.85 -0.73 -0.12

Size



9/16/2019



Effect -0.07 -0.85 -0.73 -0.12

Size



9/16/2019



Effect -0.07 -0.85 -0.73 -0.12

Size



9/16/2019



Effect -0.07 -0.85 -0.73 -0.12

Size



9/16/2019



Effect -0.07 -0.85 -0.73 -0.12

Size

#1 Signal “Dampening” Secondary to Optical Index Changes During OCT

Imaging

Scleral Lens Soft Lens

Sympathetic Swelling Response of the Control Eye to Soft Lenses in the Other Eye

Desmond Fonn, Renee du Toit, Trefford Simpson et al.Cornea, December 1999

DK 18 HEMA

No Lens Control No Lens Control

DK 140 SiHy

#2 Sympathetic Response Sympathetic Swelling Response of the Control Eye to Soft Lenses

in the Other Eye Desmond Fonn, Renee du Toit, Trefford Simpson et al.

Cornea, December 1999

DK 18

DK 140

Change in Peripapillary RNFL Thickness (in subjects with increase in IOP >10mmHg)

The decrease in

Peripapillary RNFL

Thickness tended to

be more significant

in the subjects that

had increases in

IOP of 10mmHg or

greater during

scleral lens wear.9/16/2019 207

In this study 9 eyes (of 31 subjects) had an

increase in IOP of 10 mmHg or greater.

Subfoveal Choroidal Thickness

Measurement with OCT TOOL (QUT)

9/16/2019 208

(Blue Line) Chorioial-Scleral Interface

1. At the fovea

2. At the optic disc3. 3.25mm temporal to the fovea

(Green Line) RPE/Bruch’s Membrane Complex

1

23

In this 8 hour evaluation…there was

no statistical significant changes

in…

• Inside disc radialperipapillary capillarydensity

• Sub-foveal thickness

• Ganglion cell complexthickness

9/16/2019 209

Summary

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

application of the SCLs.

The increase in IOP remained constant throughout

the wearing period of 8 hours and dropped back to

the baseline measurement immediately post lens

removal

9/16/2019 210

Summary

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

chronic exposure to a decrease in RNFL thickness ???

9/16/2019 211

Journal of the American Medical Association July 2015

Optic NerveBlood Profusion

In our 2018 study 11 of the 28 eyes had an

increase in IOP of 10 mmHg or GREATER

In this study 9 eyes (of 31 subjects) had an

increase in IOP of 10 mmHg or greater.

ConsiderationsThe 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???

9/16/2019 214

Future Thoughts• Our results are looking at the BEST CASE SENERIO.

• These were young heathy eyes

(average age 26.3 SD 2.5).

• Free of ocular and systemic disease.

• With a limited wearing exposure of 8 hours.

215

Future ThoughtsOur results are looking at the BEST CASE SENERIO.

• These were young heathy eyes(average age 26.3 SD 2.5).

• Free of ocular and systemic disease.

• 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???

Followed by post-removal and sleep when the IOP is potentially, its greatest???

216

Norman Bier

1943First to patent the use of fenestrations

in first glass and then PMMA scleral

Contact Lenses

Donald Ezekiel and Fenestrated

Scleral Lenses

Donald Ezekiel and Fenestrated

Scleral Lenses

What is the best technique for managing pinguecula?

Smaller

Scleral

Lens Design

Diameter: 14.5 mm

14.5 mm Lens Design

Fissure Size and Lens Diameter Left Eye 14.5 mm ScleralSevere 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...

Are we missing something?The Average Eyelid

•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

Apical

Clearance

OK?

Not OK?

300 um 600um

Right Axial Left Axial

Right Elevation Left Elevation

Summary

Controversies in Myopia ControlWhat we know in 2019

“Is there anything that can be done to

control my child’s increasing myopia???

For Centuries Scientists have Debated

the Question of Whether Myopia is:

• Genetic, (Nature)

- Ethnicity

- Family inheritance

• Environment, (Nurture)

- Molded by visual experience.

Myopia is the result of a complex interaction

between…BOTH

Dr. Monica JongBrien Holden Vision Institute

FedOpto Medillian Columbia 2015

Dr. Monica JongBrien Holden Vision Institute

FedOpto Medillian Columbia 2015

70% of today’s myopia is environmentally

driven 30% is genetic.

What has changed in our children’s

environment in the past 50 years???

Prevalence of Myopia East Asia

11

Greater than 80% in Hong

Kong, Taiwan & Singapore

5 to 7% in rural,

uneducated groups

(Morgan 2006)

5% in grandparents in

Hong Kong (Lam 1994)

Suggest environmental factors rather than

genetic factors are responsible for influx

of myopia.

Military Candidates

• Jung et al (IOVS 2012) reported 96.5% prevalence

of myopia in 19 year old South Korean military

candidates.

• Lee et al (IOVS 2013) reported 86.1% prevalence in

19 year old Taiwan military candidates.

Prevalence of Myopia and High Myopia

in 5,060 Chinese University Students in

ShanghaiJing 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





• Mean spherical equivalent refraction

-4.12 D.



• 19.5 % were highly myopic

> -6.00 D.

Increased Prevalence of Myopia in the

US Between 1971-1972 and 1999 -2004

Susan Vitale PhD, Robert Sperduto MD, Frederick Ferris MD

Archives of Ophthalmology Vol. 127 No. 12 December 2009

Ages 12 -54

1971-1972 1999-2004

25.0% 41.6%

Myopic Myopic

In 30 years a 62% increase in myopia

Changes in Myopia Prevalence Among First-Year University Students in 12 Years

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 thelifestyle changes of the studied population.”

Today

Our

Kid’sToday

Near Work and MyopiaThe possible role of near work in the genesis

of myopia has been extensively explored

with inconclusive and conflicting results.

A Randomized Clinical Trial to Assess the

Effect of a Dual Treatment on Myopia

Progression: The Cambridge Anti-Myopia Study.

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???

• In all species, (including

humans) the two eyes

typically grow in a highly

coordinated manner

towards the ideal optical

state, a process called

“Emmetropization”

• The process is regulated

by visual feedback.

Fundamental Across All Species

Rodents

Primates

Cats

Rabbits

Marsupials

Birds

Fish

Survival

of the

Species

The Evolution of Man and Vision

20/400 20/20

The Evolution of Man and Vision

20/20

Chronic Image Degradation Causes Myopia

Wiesel & Raviola 1977

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.

Monocularly lid-sutured Monkey

Chronic Image Degradation Causes Myopia

Wiesel & Raviola 1977

Monocularly lid-sutured Monkey

Form Deprivation Myopia

If an eye that has from-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 StudiesOptically imposed refractive errors produce

predictable refractive changes

Positive Lens Treatment Negative Lens Treatment

The eye becomes more

HYPEROPIC

The eye becomes more

MYOPIC

The signal for the eye to grow is DEFOCUS

Lens Compensation in MonkeysRefractive Error is the Signal

Smith et.al. Univ. of Houston

What do the Lens Compensation

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 Monkeys

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

Wallman and Winawer

Myopia Control

Neurotransmitting Chemicals

• Luminance

• Electromagnetic /

Chromatic Signal

• Diet

Optical Defocus

What Guides Refractive Error

Development In Humans

Myopic

Defocus

Hyperopic

Defocus

Children who spend more time outdoors are

less likely to become myopic.

Outdoor Light….Luminance

Ambient Lighting Levels

1,000 LUX

50,000 lux

250 lux

Earl Smith

Light Exposure and Physical Activity in

Myopic and Emmetropic ChildrenScott Read, Michal Collins, Stephen Vincent

Queensland University of Technology

Optometry and Vision Sciences 2014

Light Exposure and Eye Growth in

ChildhoodScott Read, Michael Collins & Steve Vincent

Investigative Ophthalmology and Visual Science 2015

• 18 month prospective longitudinal study

• 101 children ages 10 to 15

• 41 myopes (SE -2.39 +- 1.51 D.)

• 60 non-myopic (SE +0.35 +- 0.31 D.)

• Actiwatch 2 devices to measure ambient light

exposure and physical activity.

• Worn for two - 14 day periods every six months.

• Axial length measurements every 6 months.

Average Axial Eye Growth…

18 Months

L

Low Daily Light Exposure

Moderate Daily Light Exposure

High Daily Light Exposure

Average Daily Bright

Light

Exposure (>1000 lux)

• Low Daily Light

• 56 min/day

• Moderate Daily Light

• 90 min/day

• High Daily Light

127 min/day

Light Exposure and Physical Activity in Myopic and Emmetropic Children

Scott Read, Michal Collins, Stephen VincentQueensland Institute of TechnologyOptometry and Vision Sciences 2014

No significant differences were found between the average daily physical activity

levels of myopes vs emmetropes.

Myopia Control


• Luminance


Chromatic Signal

• Diet

Optical Defocus



Myopic

Defocus

Hyperopic

Defocus

Myopia or hyperopia can be induced in chicks

and reversed by manipulation of the

chromaticity of ambient light

• Baby chicks were raised in…

red light…..(90% red and 10% green)

blue light… (85% blue and 15% green)

• 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.

WS Foulds, VA Barathi, CD Luu

Singapore Eye Research, IOVS January 2014

.

Childs Corrected

Myopic Eye

Image

Shell

1.25 D.

Hyperopic

Defocus

Relative stimulation of different cones

Red / Green

Grow ???

Blue / Green

Stop ???

Myopic

Defocus

Myopia Control


• Luminance


Chromatic Signal

• Diet

Optical Defocus



Myopic

Defocus

Hyperopic

Defocus

The High Prevalence of Myopia is New.

What has changed in the past 30 years?

Metabolic Syndrome EpidemicMetabolic syndrome is not a disease in itself.

Instead, it's a group of risk factors:

–High blood pressure

–High blood sugar

–Unhealthy cholesterol

levels

–Abnormal fat levels

Diet

Processed foods

Added sugars

Refined grains

The Metabolic “Perfect Storm”

• Spikes in glucose leads to spikes in insulin

in the blood (choroid).

• More insulin in the blood the stronger

signal to growth receptors in the sclera.

• Suppressed outdoor light and excess

insulin lead to a “perfect storm” for a

growing eye.

• i.e. China since the cultural revolution -

<5% myopia to 90%.

Myopia Control


• Luminance


Chromatic Signal

• Diet

Optical Defocus



Myopic

Defocus

Hyperopic

Defocus

Emmetropic Children

Have Myopic Defocus

Myopic

Defocus

.

Childs Corrected

Myopic Eye

Image

Shell

1.25 D.

Hyperopic

Defocus

Prescribing Single Vision Lenses

• Childhoodrefractive errorsare diagnosed atan earlier age:– School Screening

– Optometricadvertising

• We correct thechild’s centralvision HOWEVERspectacle lensesincrease peripheralhyperopicdefocus.

Myopic

Defocus

Over the past 30 years billions of people worldwide have seen dramatic changes

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

System, is the SIGNAL for

the Eye to Grow?

Reduction ExperimentsFDM does NOT require the visual signal to leave the eye.

Axial eye growth continues

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 ???

The fovea DOES NOTplay the dominate role in refractive development.

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

Earl Smith OD PhD

University of Houston

A functioning fovea is not essential for

normal axial development.

Conclusions, Smith et.al.

#1

An Intact Fovea Is Not Essential for

Normal Axial Eye Growth

Smith et. al. Univ of Houston

An intact periphery is essential for

normal axial development.

Conclusions Smith et.al.

#2

Hemiretinal Form Deprivation: Evidence for

Local Control of Eye Growth and Refractive

Development in Infant Monkeys

Earl L. Smith et al.

Investigative Ophthalmology & Visual Sciences

Vol50 No. 11 November 2009

Study Control

Eye Eye

No FDM

FDM Left Eye

Control Control

Eye Eye

Study

EyeControl

Eye

Peripheral retinal receptors take in visual

information and provide the signal for the eye

to grow (or to stop growing) in a

regionally selective fashion.

The vision-dependent mechanisms that regulate eye

growth are located IN THE EYE.

Study Control

Eye Eye

Myopic

Defocus

Myopic

Defocus

Orthokeratoloy

Multifocal SCL

Myopic

Defocus

Spectacle Lenses

The Delivery of

Myopia Control OpticsOptical 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)

The Optics of

Orthokeratology

How Does It Work ???

Minus Power Lens…Made of Epithelium

The Epithelium and OK Squeeze Film ForceThe 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

Wing

Cells

Basal

Cells

Thickness: 50 um

Water Content: 75%

Ref. Index: 1.382

Surface

Cells

Mid-Peripheral Central Cornea Mid-Peripheral

Jennifer Choo OD PhD, Patrick Caroline, Dustin Harlin et.al.

ControlControl

37.49 38.5934.75

73.07

Central Epithelium

Mid-Peripheral Epithelium

<3 microns

Apical Thinning

Epithelial Cell Compression

Compression

Normal

Reverse Geometry GP

10 minutes of Lens Wear

Intercellular Fluid TransferGap Junctions:

Small protein channels that permit cell contents

to move from one cell to another.

Central Epithelium

Mid-peripheral Epithelium

#1 Geographic Tissue Changes

#2 Mid-Peripheral Cornea

8 Hours 2 Weeks

Normal Cat Epithelium

Control

Right Eye Left Eye

Methods: Jennifer Choo et.al.

15 Two-year old cats

Randomly fitted with myopic OK and Alignment

fitting GP lens

Same diameter: 12.3 mm

Same thickness: 0.16 mm

OK Lens Design Alignment Design

MethodsOvernight (16 hr) lens wear for all animals

Histological analysis of corneas (5 regions)

1 day, 1 week, 2 weeks, 4 weeks after

starting lens wear

Slit Lamp Examination

Corneal Topography

To confirm appropriate corneal changes

Ortho K Eye Alignment Eye

Average Corneal Change -4.50 D.

Progressive Epithelial ChangesJennifer Choo OD PhD

Control

1 Day

4 Week

1 Week

OK Eye Alignment Eye

1 2 3 4 5 1 2 3 4 5

1

23

4

5

Jennifer Choo OD PhD

#1 Epithelial Cell Retention?

14 Days Post CRT

• Alterations in cell apoptosis

• Decreased cell sloughing

• Increased cell mitosis

Axial Display Tangential Display

Increasing (+)

Power Over the Pupil

#2 Peripheral Cell Migration?

OK… How It Works• Cellular compression with

intercellular fluid transfer

• Increased cell mitosis

• Increased cell retention

• Localized stromal remodeling ?

• Multifactoral

-4.00 D. Change

75 microns

50 microns

Change in Elevation = -14 microns 75 microns

50 microns -14 microns

Pre-Fitting Corneal Shape

Post Fitting Corneal Shape

Scanning Electron Microscopy

Average Human Hair

“75 microns thick”

14

microns

1000 X

-4.00 D. Correction

Right Eye

Dispensing Visit

Right Eye

2 Week Visit

Rx: -4.00 D..

-1.00 D.

-7.00 D.

5.0 mm

Rule #1In OK

The

distant

optical

zone is

only

1 to 2 mm

in

diameter

-4.25 D.

+4.00 D. +4.00 D..

Post -4.75 LASIK

-4.75 D.

5.0 mm Pupil

-4.75 D

Post OK -5.00 D.

5.0 mm Pupil

-5.00 D

5.0 mm Pupil

-4.75 D..

5.0 mm Pupil

-5.00 D.

LASIK

Ortho-K

5.0 mm

Rule #1In OK

The

distant

optical

zone is

only

1 to 2 mm

in

diameter

Rule #2The amount

of plus

power in the

periphery

equals the

amount of

minus

power

corrected

-4.25 D.

+4.00 D. +4.00 D..

Foveal Orthok Effect: -1.00 D.

-1.00

-0.75

+0.75 Add


-2.00

-0.50

+1.50 Add


-3.00

0.00

+3.00 Add


-4.00

-0.75

+3.25 Add


-5.00

-1.50

+3.50 Add


-8.00

0.00

+8.00 Add


-10.00

0.00

+10.00 Add


-3.00

0.00

+3.00 Add


-3.00

-0.75

+2.25 Add


-3.00

-1.50

+1.50 Add

If Plus (Myopic Defocus) is the

Mechanism for Myopia Control

Myopic

DefocusMyopia Control Design Adult Ortho-K Design

5.4 mm 6.8 mm

+2.36 D

+-0.62 D.

+3.55 D

+-1.35 D.

+0.76 D

+-0.65 D.

+3.04 D

+-1.03 D.

5.4 OZ N = 7 6.8 OZ N = 7

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

Study #1

5 year follow-up Study # 2

5 year follow-up

165 Subjects 330 Eyes

Spherical 6.0 mm OZ, in

a 5 curve lens design


Aspheric 5.4 mm OZ, in


Propensity Score AnalysisMatch eyes with similar baseline characteristics

Age, axial length, spherical equivalent power, keratometry, eccentricity,

corneal diameter pupil size and central corneal thickness

191 Eyes 191 Eyes

1.55

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

AsianMyopes

<-2.00 -3 -4 -5 -6 -7

5 Y

ea

r A

xia

l L

en

gth

Ch

an

ge F

rom

BL

CLEERE Spectacle Study Data

-4.50 D or -0.90 D. per year

6.0 mm OZ

0.00

Spherical 6.0 mm OZ Lens Design

1.55

1.665

1.325

0.883

0.615

0.482

0.255

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

AsianMyopes

<-2.00 -3 -4 -5 -6 -7

5 Y

ea

r A

xia

l L

en

gth

Ch

an

ge F

rom

BL


Study #1 Spherical 6.0 OZ Design

Myopia Control Studies with Ortho-K

Average 48.8 %

Good Myopia Control N = 112Small changes in axial elongation

Study #1

5 year follow-up




Propensity Analysis

191 Eyes

Poor Myopia Control N = 79Large changes in axial elongation

Chow Study 5 year Axial Length

6.0 mm OZ

N = 191 eyes

191 Eyes

• 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)

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:

191 Eyes

• 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)

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:

-1.00 Rx Change

Foveal Orthok Effect: -1.00D

-1.00

-0.25

+0.75 Add

-4.00 Rx Change

Foveal Orthok Effect: -4.00D

-4.00

-0.75

+3.25 Add

Comparison of Rx Changes

+0.75 Add

+3.25 Add

-1.00 Rx

Change

-4.00 Rx

Change

Orthok Tear Layer Profile

-1.00 Rx

Change

-4.00 Rx

Change Good Myopia ControlSmall changes in axial elongation

Study #1

5 year follow-up Study # 2

5 year follow-up





Aspheric 5.4 mm OZ, in


Propensity Score Analysis

191 Eyes 191 Eyes

Poor Myopia ControlLarge changes in axial elongation

5.4 mm OZ

Aspherical 5.4 mm OZ Lens Design

5 um

0.00Spherical 6.0 mm OZ Lens Design

5 um

Aspherical 5.4 mm OZ Lens Design

1.55

0.525

0.419

0.336 0.331

0.438

0.23

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

AsianMyopes

<-2.00 -3 -4 -5 -6 -7

5 Y

ea

r A

xia

l L

en

gth

Ch

an

ge F

rom

BL


Study #2 Aspheric 5.4 OZ Design

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

AsianMyopes

<-2.00 -3 -4 -5 -6 -7

5 Y

ea

r A

xia

l L

en

gth

Ch

an

ge F

rom

BL


Study #1 Spherical 6.0 OZ Design

Study #2 Aspheric 5.4 OZ Design

Chow Study 5 year Axial Length

5.4 mm OZ

N = 191 eyes

Animal Study’s to

Human Application

Graded Competing Regional Myopic and

Hyperopic Defocus Produces Summated

Emmetropization Set Points in ChicksDennis Y. Tse and Chi-ho To IOVS 2011

Center for Myopia Research, School of Optometry, Hong Kong

Polytechnic University

Investigated the axial

response of the eye

when a specific

proportion of the retina

was exposed to myopic

defocus while the

remainder was exposed

to (competing)

hyperopic defocus.

“As the proportion of retinal area receiving myopic

defocus increased…the degree of myopic eye

growth was reduced”. RESULTS:

Correction Ratio VCD

-8.90 D 0/100 +592

-2.40 D 25/75 +230

+1.60 D 33/67 -105

+5.90 D 40/60 -253

+7.60 D 50/50 -447

+10.40 D 100/0 -515

Myopic Defocus Hyperopic Defocus

Myopic

Defocus

Hyperopic

Defocus

Axial Eye Growth and Refractive Error Development

Can be Modified By Exposing the Peripheral Retina

to Relative Myopic and Hyperopic Defocus

1. Plano, Center Distance 1.5 OZ (+5.00 D. Add)

2. Plano, Center Distance 3.0 OZ (+5.00 D. Add)

3. Plano, Center Distance 3.0 OZ (-5.00 D. Add)

4. Total correction +5.00 D.

5. Total correction -5.00 D.

Benavente-Perez, A, Nour, A., Troilo, D.

SUNY College of Optometry

Investagative Ophthalmology , September 2014

30

Primates

5

1

4

3

2

Results and Conclusions

“Eye growth and refractive state can be manipulated by altering

peripheral retinal defocus.”

“Imposing peripheral MINUS produces axial myopia”.

“Imposing peripheral PLUS produces axial hyperopia”.

“The effects are smaller than using single vision CL’s that impose full

field defocus. This supports the use of multifocal CL’s as an effective

treatment for myopia control”.

Vitreous

Chamber

DepthRefraction

Minus

Plus

1

32

45

Longer

Shorter

34

21

5

Myopia Control Design Adult Ortho-K Design

Axial Power Display

-5.00 D. Change

Munnerlyn FormulaDepth of the Treatment Zone Equals

Optical Zone Diameter ² X Refractive Error

3

Treatment Zone Diameter = 5.0 mm

OZ Squared 5.0 x 5.0 = 25

Times the Refractive Error = -5.00 D.

125

Divided by 3 = 42

Tissue Change = 42 microns

Munnerlyn FormulaDepth of the Treatment Zone Equals

Optical Zone Diameter ² X Refractive Error

3

Treatment Zone Diameter = 2.0 mm

OZ Squared 2.0 x 2.0 = 4.0

Times the Refractive Error = -5.00 D.

20

Divided by 3 = 7

Tissue Change = 7 microns

Munnerlyn’s Formula -5.00D.Treatment Amount of

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

6.0 mm 60 microns

Dedicated Myopia Control Design

6.5mm OZ

5.5mm OZ

Anterior Aspheric Lens Diameter10.5 to 11.0mm

Back Surface Toric…















• 19.5 % were highly myopic

> -6.00 D.

CFDA Approved Myopia

Control in China

• Overnight orthokeratology

is approved in children for

Myopia Control from…..

-0.50 D to -5.00 D.

• Soft contact lenses

(multifocal SCL’s) can not

be fitted to children or

young adults under the

age of 18.

Therefore, GP multifocal lenses design have

found a place in the Chinese culture.

Anterior Surface Optics

Distance

Minus

Peripheral

Plus

Peripheral

Plus

Distance

Minus

Peripheral

Plus

Optical InterventionsRigid Contact Lenses

• Orthokeratology


Soft Contact Lenses




Spectacle Lenses

• Bi-focal lenses

• Aspheric optic


The DEFOCUS THEORY…. With (-) Lenses

GREATER (+) Power in the Periphery

.

Myopic

Defocus

Conflicting

Retinal

Signals

Theory

MINUS

PLUS PLUS

MINUS MINUS

PLUS PLUS

“Any Amount

of Plus

Anywhere in

the Eye”Dr. Thomas Aller

Exposing the eye to

conflicting signals…

Myopic defocus (good

stuff) and hyperopic

defocus (bad stuff).

Center Near MF Designs for MC

Cooper Vision Cooper Vision J&J

Pete

Kollbaum

Center Distance Multifocal Soft Lens Designs

MiSight Proclear MF

Biofinity MF

Acuvue Oasys

D D D

Acuvue Oasys for Presbyopia

Distance Powers:

-0.50 to -9.00 D.

Near Powers:

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

0.15

1.361.79

0.210.73

-2.77

-1.73-1.27

-2.76-2.05

-5.70

-4.70-4.27

-5.78-5.10

-8.68

-7.66 -7.19

-8.80-8.42

-10.00

-8.00

-6.00

-4.00

-2.00

0.00

2.00

4.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00

Dio

ptr

ic

Po

we

r

Acuvue Oasys +2.50 MF

plano -3.00 -6.00 -9.00

MAX

ADD1.4 mm

+1.64 D.

+1.50 D.

+1.43 D

+1.49 D.

Average

+1.51 D.

Hemi Chord

+1.50-3.00 +1.50

Cooper Vision Biofinity Multifocal

Distance Powers:

-0.50 to -10.00 D.

Near Powers: +1.00, +1.50,

+2.00, and +2.50 in both D

and N lens designs.

DK = 128 Design 8.6 / 14.0

0.390.68

2.09

2.70

-2.58-2.44

-1.11 -1.01 -1.01

-5.66 -5.52

-4.44-5.00

-7.00

-6.00

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

2.00

3.00

4.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00

Dio

ptr

ic

Po

we

r

CV Biofinity +2.50 MF

plano -3.00 -6.00 -9.00

Hemi Chord

MAX

ADD2.0 mm

+2.31 D.

+1.57 D.

+1.22 D.

Average

+1.70 D.

+1.57 -3.00 +1.57

Cooper

Vision,

MiSightDual Focus

Design

D N D N

-0.54-0.59

0.40

1.42

-0.41

-2.63-2.75

-0.73

-0.74

-2.86

-5.53-5.59

-3.68

-3.65

-5.92

-7.00

-6.00

-5.00

-4.00

-3.00

-2.00

-1.00

0.00

1.00

2.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00

Dio

ptr

ic P

ow

er

Cooper Vision MiSight

-0.50 -3.00 -6.00

MAX

ADD2.0 mm

+1.96 D.

+1.90 D.

+ 1.88 D.

Average

+1.91 D.

+1.90 -3.00 +1.90

Visioneering Technologies, Inc.

NaturalVue 1-Day Multifocal

Extended Depth of Focus Design

-0.08 0.06

1.20

2.39

0.53

-2.92 -2.88

-1.65

-0.32

-2.96

-6.31 -6.22

-5.19

-4.07

-6.71

-9.57-8.92

-8.05

-6.83

-10.21

-12.56 -12.60

-11.33-10.53

-14.20

-16.00

-14.00

-12.00

-10.00

-8.00

-6.00

-4.00

-2.00

0.00

2.00

4.00

0.00 0.50 1.00 1.50 2.00 2.50 3.00

Dio

ptr

ic

Po

we

r

NaturalVue MF

plano -3.00 -6.00 -9.00 -12.00

Hemi Chord

MAXADD

2.75 mm

(5.5 mm)

+2.47 D.

+2.60 D.

+2.24 D.

+2.74 D.

+2.03 D.

Average

+2.41 D.

+2.60 -3.00 +2.60

NaturalVue -3.00 D.

-3.00 D.

Chord 2.0 mm

+2.50 D. +2.50 D.

Chord of max. add 5.5 mm-4.50 D. -4.50 D.

All Lenses Center Distance -3.00 D.

With Maximum Add Powers

Acuvue Oasys BioFinityMax Add @ 2.8 Max Add @ 4.0 mm

MiSight NaturalVueMax Add @ 4.0 mm Max Add @ 5.5 mm

All Lenses Center Distance -3.00 D.

With Maximum Add Powers

Acuvue Oasys BioFinityMax Add @ 2.8 Max Add @ 4.0 mm

MiSight NaturalVueMax Add @ 4.0 mm Max Add @ 5.5 mm

+1.50 D.

+1.57 D.

+1.90 D.

+2.60 D.

Concentration of Add Power

Physical area of the retina involved

in the peripheral defocus process

Concentric Aspheric Addition Design

NN

DN ND

Concentric Linear Addition Design

N NN

DD

Concentric Constant Addition Design

N NN

DD

N

Art Tung’s OK Soft Lens Design Optical InterventionsRigid Contact Lenses

• Orthokeratology


Soft Contact Lenses




Spectacle Lenses

• Bi-focal lenses

• Aspheric optic


“In conclusion, our

results provide

evidence that

correction of single

vision spectacle lenses

induced absolute

hyperopic defocus on

the retinal periphery of

low and moderate

myopic eyes”

2010

Hyperopic Defocus

Prescribing Single Vision Lenses

• Childhoodrefractive errorsare diagnosed atan earlier age:– School Screening

– Optometricadvertising

• We correct thechild’s centralvision HOWEVERspectacle lensesincrease peripheralhyperopic defocus.

ZeissMyoVision

spectacle

lenses for

myopia control

in children

EssilorMyopilux

spectacle lenses

for myopia

control in

children

3 Myopia Control Designs

• Comprised of a central optical zone for correcting the myopia

and astigmatism.

• Surrounded by multi-segments (micro lenses) of constant

myopic defocus extending to mid-periphery of the lens.

The Hoya DIMS Spectacle Lens

It provides myopic defocus

simultaneously for the wearer at all

viewing distances.

• A randomised double-blinded clinical trial was conducted from August 2014

to July 2017.

• The study comprised 160 Chinese children aged 8 to 13, with myopia from 1

to 5 diopters (D), and astigmatism and anisometropia of 1.50 D. or less

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.

Children wearing the DIMS Spectacle Lenses had 59% less

myopic progression and 60% less axial elongation.

The Study and Results

Atropine and Myopia Control

Atropine Control % Change

Group Group Annual RE

Progression

Yen 0.22 0.91 76%

Shih 0.04 1.06 96%

Chou 0.14 0.60 77%

1%

Atropine

Atom 2 StudyChia, et.al. Ophthalmology 2011

Atropine for the Treatment of Childhood Myopia 400 children ages 6 – 12 with greater than -2.50 D.

Myopia %

ATOM 1 Progression Reduction

Placebo -1.20 D.

Atropine 1% -0.28 D. 77%

ATOM 2

Atropine .5%

(2 x less concentration) -0.30 D. 75%

Atropine .1%


Atropine .01%


Changes in Axial Length and

Spherical Equivalent Over 2 Years

Jeffery Cooper OD

Atom 1 and Atom 2, Axial Length

Ophthalmology 2018

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.

Placebo

0.01%

0.025%

0.05%

Change in

Axial Length

Summary“Is there anything that can be done to

control my child’s increasing myopia???

Optical InterventionsRigid Contact Lenses

• Orthokeratology


Soft Contact Lenses




Spectacle Lenses

• Bi-focal lenses

• Aspheric optic


Curvature versus Elevation · 20.0 mm Chord Low Corneal Astigmatism < 0.75 D High Corneal...

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Transcript of Curvature versus Elevation · 20.0 mm Chord Low Corneal Astigmatism < 0.75 D High Corneal...