ok customized - optometric education consultants · 2019‐06‐14 10 final design of 3mod: 7...
TRANSCRIPT
2019‐06‐14
1
ÉTUDE DE L’ADDITION PÉRIPHÉRIQUE OPTIMALE DANS UNE LENTILLE MULTIFOCALE POUR CONTRÔLE DE MYOPIE
Simon-Pier Falardeau, Guillaume Landry-Proulx
Langis Michaud, Rémy Marcotte Collard, Patrick Simard
École d’optométrie Université de Montréal
ORTHO‐K: MYOPIA CONTROL IS NOT MYOPIA CORRECTION
Dr Langis Michaud O.D. M.Sc. FAAO (Dipl) FSLS FBCLA FEAOO
Professor
Dr Daniel Brazeau O.D. FAAO
Clinical Instructor
École d’optométrie Université de Montréal
Dr Michaud: Honorarium or reserach fund received
Bausch & Lomb
Cooper Vision
VIT- NAturalEyes
Synergeyes
Co-owner USPTO 62/590,388 Medical device for axial length and myopia management
Dr Brazeau: Nothing to disclose
Disclosure
EPIDEMIC MYOPIA ? REALLY ?
?
2019‐06‐14
2
According to Oxford dictionary epidemic means A widespread occurrence of an infectious disease in a community at a particular time.
Most likely not applicable to myopia…. BUT…. It means also …
1.1 A sudden, widespread occurrence of an undesirable phenomenon
- This is myopia
Is myopia epidemic ?
X 2 prevalencein 20 years…
sudden if referred to
human hx scaleAsia
Europe North
America
RetinaldetachmentGlaucoma
At riskcataract sx
How Bad is the Myopia Epidemic?
Doing nothing is doing something
Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050.
Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. Review.
2019‐06‐14
3
How would you define myopia ?
1. Simple refractive error easily correctable
2.A significant risk factor for legal blindness
3.A loss of emmetropization process
Understanding myopia
Emmetropization• The bulk of emmetropization occurs in early
childhood and is largely complete by age 6.
• Therefore, refractive errors that exist at this age can be considered failures of emmetropization.
• The commonest refractive error at age 6 is hyperopia with both anisometropia and myopia being far less common at this age.
• Therefore if you have a myopic spherical equivalent in a child 6 and under, you have a very high likelihood and predictability factor that the child will be myopic in the future.
IOVS/IMI WHITE PAPERS
2019‐06‐14
4
Where does myopia come from ?
GENETICS
MYOPIA
EPIGENETICS
30% 70%
The real myopia-suspect
Less time spent outdoors (<60-90 min / day)
One or two myopic parents
Binocular vision disorders(Esophoria, Accom lag, High AC/A)
Jones et al 2007, Read et al 2014, Xiong et al 2017, Gwiazda et al 2005.
Near esophoria
Accommodative lag
Higher AC/A ratios
Greater variability in accommodative responses
Myopia = inaccurate BV behaviour
Bennett et al 1989, Bullimore et al 1992, Rosenfield et al 1994, Drobe et al 1995, Gwiazda et al 1995,Abbott et al 1998, Gwiazda et al 1999, Mutti et al 2000, Rosenfield et al 2002, Vera-Diaz et al 2002, Chen et al 2003, Wolffsohn et al 2003, Nakatsuka et al 2005, Allen et al 2006, Pandian et al 2006, Harb et al 2006, Mutti et al 2006, Ciuffreda et al 2008, Vasudevan et al 2008, Lin et al 2012
2019‐06‐14
5
WHY SHOULD WE BOTHER ?
Because there is no ‘safe’ level of myopia
MYOPIA - Increased risk
Glaucoma Cataract RetinalDetachment
MyopicMaculopathy
< -3.00 1.65 2.1 3.1 2.2
-3.00 to -6.00 2.46 3.1 9.0 9.7
> -6.00 3.5 5.5 21.5 40.6
What to expect ?
A child should become emmetropic between 6-8 years oldSooner: predictive of future myopia
After myopia onsetNatural progression: -0,50D /year ; AL: 0.2mm /year Increased in Asian, female, youger subjects
-1D @ 8 y.o. will become -5.00 @ 16 y.o.
2019‐06‐14
6
GOALS: WHAT ARE THE TARGETS
Odds ratio of visual impairment by age 60
Prevalence of visual impairment by age 75
24-26mm 1 (reference) 4%
26-28mm 2 x risk 25%
28-30mm 11 x risk 27%
30mm + 25 x risk 90%
Undercorrection : form deprivation
Near work
Lightning
Tablets /Ipads : chromatic aberrations
High order aberrations
RISK FACTORS FOR PROGRESSION
Earl Smith. Vision By Design 2018
Defining the right strategy
2019‐06‐14
7
Contact Lens Spectrum, Volume: 31 , Issue: March 2016, page(s): 36-42
Defining a Strategy for Myopia ControlA systematic approach can help practitioners more effectively implement myopia control into practice.By Langis Michaud, OD, MSC, FAAO (Dipl), FSLS, FBCLA; Patrick Simard, OD, MBA, MSC, FAAO; & Rémy Marcotte-Collard, ODAny eyecare practitioner who has not been living on another planet for the last few years should by now be aware that myopia is no longer considered a benign refractive error that can be compensated for with regular glasses or contact lenses. In reality, thanks to the tremendous legacy of the late Prof. Brien Holden, we are now aware that myopia has become epidemic and sight-threatening.
Contact Lens Spectrum, Volume: 32 , Issue: September 2017, page(s): 20-26
Working on the 3 pillars of myopia control
Basic Principles
BinocularVision
Environmentalconditions
Optical Blur
OPTICAL 1. Contact lenses as soon as possible 2. Prescribe spectacles (progressive / bifocals) if the child is not suitable
for contact lenses.3. Consider adding low dose atropine if optical correction (CL’s or
spectacles) does not provide sufficient myopia control
CONTROL OF THE BLUR
2019‐06‐14
8
The Montreal approach
Myopia Control Strategy defined :
- age /willingness to wear lenses
- how aggressive should we be
- diopters (low vs high myopes)
- ocular parameters
- asphericity vs K
- pupil size
- risk of infections /compliance
- CUSTOMIZATION CUSTOMIZATION
Customizedorthokeratologydesign allowssmaller pupils to befitted
Adjunct therapy with
Atropine 0,025% since
LAMP Study update
Customized
orthokeratology provide
highest rate of control
2019‐06‐14
9
Need to customize lens designs for every patient Myopia correction is not myopia control
Key elements Lens diameter: larger for myopia control Larger + zone Lens covers 90-95% corneal diameter
Central zoneNo touch : 5-10 um Distance zone vs + zone: adjust for the pupil size A smaller treatment zone is habitually required
Spherical vs toric BC
OK for refractive correction vs myopiacontrol
Return zone Determines the hydraulic tension under the lens ; CENTRATIONHigher to generate more + power Toric peripheral curves Any astigmatism > 1.50 IF limbus to limbus If elevation difference between 2 principal meridians > 30 um.
Utility of a second reservoir Centration evaluation Increased pressure in the first reservoir
Landing zone A better « seal-off » helps to generate more + Higher angle (1 step) is required in most cases
OK for refractive vs myopia control
DRL lens
2019‐06‐14
10
Final Design of 3MOD: 7 curves
Value (mm) Value (microns)Width r0 2,7 TLT Apex 15Width r1 0,3 TLT End of OZ Flat VariableWidth r2 0,3 TLT End of r1 Flat 75Width r3 0,7 TLT End of r2 Flat 15Width r4 0,5 TLT End of r3 Flat 0Width r5 0,5 TLT End of r4 Flat 0Width r6 0,3 TLT End of r5 Flat 15
Peripheral Edge Flat 100
Flat e correction -0,05Steep e correction -0,05
SphericDesign
Toric Design
Example on a spherical cornea
Example on a spherical cornea
2019‐06‐14
11
SphericDesign
Toric Design
Example on a toric cornea (-2,00 D astigmatism)
Is this working ?
To evaluate the efficacy of customized OK lens design on a population of myopic patients 1st outcome: axial length elongation over time 2nd outcome: myopia progression over time To analyze induced corneal shape
variations based on differential tangential maps
Cohort of RGP Designer (3MOD)
2019‐06‐14
12
1. Treatment zone parameters were determinedbased on corneal curvatures, eccentricity andpupil
2. Total diameter and toricity of the alignmentcurve are designed to promote perfectcentration of the lens
3. The first reservoir volume is adjusted togenerate 75- 90 microns to enhance peripheralnet power
Objectives using our template
Control group: data from regular orthokeratology andsoft multifocals from non-customized patients seen inMTL were analyzed at 12 months (2012-2017)
Customized OK group: charts from newly fits (May 2017-December 2018) using RGP Designer software wereanalysed and compared to control
Exclusion criteria: previous optical myopia controlstrategy
Initial biometry was compare with 1 month post-treatment with Lenstar
Retrospective analysis
Characteristics of 3MOD Cohort
Number of charts available in RGP Designer software
500
Number of qualified charts 256
Starting year2017 622018 194
AverageStandard Deviation
Age at beginning (years) 11,7 ±2,4
60%
40%
Gender
Female Male
56%25%
1%18%
Ethnicity
Asians Caucasians Hispanics Others/Unknown
# Subjects %At least one Myopic Parent 139 54,3%
Less than 11 years old 95 38,9%
2019‐06‐14
13
Initial characteritics of 3MOD Cohort
96% with far exophoria: 86% with near exophoria
Mean Accommodative Lag at 40 cm: 0,73 ± 0,35 D
Mean AC/A ratio: 3,3 ± 1,8
Mean Photopic pupil size 5,65 ± 0,79 mm: Scotopic pupil size: 6,76 ± 0,59 mm
Ocular Parameters at Baseline OD OS
Axial Length (mm) 25,058 ±0,824 25,048 ±0,876Spherical Equivalent (D) -3,61 ±1,31 -3,61 ±1,38
Sim K Flat (D) 42,97 ±1,39 42,95 ±1,38Sim K Steep (D) 44,19 ±1,50 44,24 ±1,58Eccentricity Flat 0,63 ±0,10 0,63 ±0,11
Eccentricity Steep 0,47 ±0,16 0,47 ±0,15
Summary of RGP Designer Template attributes
RGP OD Average SD Minimun MaximunDefect to reduce (D) -3,20 ±0,96 -5,50 -0,50Compression Factor (D) 0,78 ±0,19 0,00 1,75Lens Power (D) 0,71 ±0,38 -2,25 2,25Total Diameter (mm) 10,65 ±0,18 10,0 11,40Toric back optic zone astigmatism (D)
-1,94 ±0,82 -1,00 -3,50
Back Optic Zone Eccentricity Value
1,00 ±1,41 0,00 2,00
Flat OD Averag
eSD
Minimun
Maximun
TLT Apex 12,5 ±24,7 -5 30TLT End of OZ
Flat 38,9 ±32,5 15,9 102,4
TLT End of r1 Flat 63,1 ±22,2 2 90TLT End of r2 Flat 13,3 ±5,2 0 60TLT End of r3 Flat 2,1 ±5,7 0 20TLT End of r4 Flat 14,5 ±5,0 0 45TLT End of r5 Flat 7,3 ±6,0 2 30TLT End of r6 Flat 14,6 ±3,1 2 25Peripheral Edge
96 6 ±12 7 50 130
65% Toric Design
12% Aspheric
BOZ
7% Toric BOZ
Comparative tangential topography analysisdone at 3 months
MARCOTTE-COLLARD, R., SIMARD, P. & MICHAUD, L. 2018. Analysis of Two Orthokeratology Lens Designs and Comparison of Their Optical Effects on the Cornea. Eye Contact Lens.
2019‐06‐14
14
3,84 3,18 2,953,81 3,11 3,000
0,51
1,52
2,53
3,54
4,5
4 curves design (n=64) 5 curves design (n=64) 6-8 curves design (n=452)Op
tica
l Z
one
mea
nd
iam
eter
(mm
)
Horizontal and Vertical Optical Zone mean with different orthokeratology design
Horizontal Optical Zone (mm) Vertical Optical Zone (mm)
ANOVA with Bonferroni Horizontal P Value Vertical P Value
6-8 curves vs 4 curves design 0,000 0,000
6-8 curves vs 5 curves design 0,027 0,054
4 curves vs 5 curves 0,000 0,000
6,1 5,67 4,736,94 6,13 5,696,81 5,8 4,647,02 6,64 6,560
2
4
6
8
10
12
4 curves design (n=64) 5 curves design (n=64) 6-8 curves design (n=452)Per
iph
era
l N
et P
ower
(Dio
pte
rs)
Quadrant Specific Peripheral Net Power (Diopter) with different orthokeratology design
Temporal Net Power (D) Superior Net Power (D)
Nasal Net Power (D) Inferior Net Power (D)
ANOVA withBonferroni
Temporal Net Power P Value Superior Net Power P
ValueNasal Net Power P Value
Inferior Net Power PValue
6-8 curves vs 4 curves 0,004 0,000 0,000 1,000
6-8 curves vs 5 curves 0,036 0,035 0,008 1,000
4 curves vs 5 curves 1,000 0,361 0,143 1,000
1,7 1,67 1,491,58 1,64 1,391,63 1,66 1,481,58 1,6 1,420
0,5
1
1,5
2
2,5
4 curves design (n=64) 5 curves design (n=64) 6-8 curves design (n=452)Wid
th o
f P
erip
her
al
Net
Pow
er (m
m)
Quadrant Specific Width (mm) of Peripheral Net Power with differentorthokeratology design
Width of Temporal Ring (mm) Width of Superior Ring (mm)
Width of Nasal Ring (mm) Width of Inferior Ring (mm)
ANOVA withBonferroni
Width of Temporal Ring P Value
Width of Superior Ring P Value
Width of Nasal Ring PValue
Width of Inferior Ring PValue
6-8 curves vs 4 curves 0,000 0,004 0,002 0,024
6-8 curves vs 5 curves 0,000 0,000 0,000 0,001
4 curves vs 5 curves 1 000 1 000 1 000 1 000
2019‐06‐14
15
y = 0,9812x + 0,4708R² = 0,9858
22,5
23
23,5
24
24,5
25
25,5
26
26,5
27
27,5
22,5 23 23,5 24 24,5 25 25,5 26 26,5 27 27,5
1 m
on
th A
xial
Le
ng
th
Initial Axial Length (mm)
Initial Axial Lenght compare to 1 month axial lenght post-treatment with Lenstar
Comparative Axial LengthN=190 Average (mm) Standard Deviation (mm)
Initial Axial Length (t=0) 25,092 ±0,8371 month Axial Length (t=1) 25,091 ±0,827
Difference:1 month-0 -0,002 ±0,100
12 months results: Myopia and Axial Length
Myopia OD Myopia OS Average (D) SD (D) Average (D) SD (D)
Customized OrthoK (3MOD) +0,47 ±0,66 +0,49 ±0,65Regular orthoK Montreal Experience -0,30 ±0,41 -0,33 ±0,41Soft Multifocal Montreal Experience -0,42 ±0,49 -0,45 ±0,51
ANOVA with Bonferroni p<0,000 p<0,000
Axial Length OD Axial Length OS Average
(mm)SD (mm)
Average(mm)
SD (mm)
Customized OrthoK (3MOD) 0,008 ±0,226 0,029 ±0,250Regular orthoK Montreal Experience 0,122 ±0,208 0,118 ±0,258Soft Multifocal Montreal Experience 0,150 ±0,156 0,162 ±0,181
ANOVA with Bonferroni p=0,005 P=0,001
Below 10 years oldBetween 10-14
years oldOver 14 years old
Average (mm) SD (mm)Average
(mm)SD
(mm)Average
(mm)SD
(mm)Customized
OrthoK (3MOD)0,139 ±0,197 -0,030 ±0,233 -0,056 ±0,101
Regular OrthoKMontreal
Experience0,222 ±0,200 0,126 ±0,209 0,002 ±0,109
Soft Multifocal Montreal
Experience0,262 ±0,132 0,094 ±0,138 0,100 ±0,101
ANOVA with Bonferroni (3MOD
vs Regular)p=0,251 p<0,000 p=0,244
ANOVA with Bonferroni (3MOD p=0,075 p=0,025 p=0,000
Axial Length by age at the beginning of treatment
2019‐06‐14
16
Higher standard deviation of the topographical analysis data ofthe customized design is showing some control over the cornealshaping compare to regular orthokeratology
Customized OK designs based on pupil size lead to an increaseeffect on axial length progression over 12 months in overall datacompare to regular orthokeratology and soft multifocal contactlens
When starting before 10 years old, customized OK still beats the3 other methods, but kids are evolving more than older patientsHarder to control /Fast progressors
Discussion
Initial axial length measurement is not altered bycorneal molding
All methods of control provide a significantmanagement of myopia in term of public health andrisks of visuals impairment in adulhood butcustomized OK offer the best outcome
Further study on orthokeratology need to describethe cornea after treatment
Take home message - CONCLUSION