2018 pedig amblyopia v1

Amblyopia
Treatment Studies
Pediatric Eye Disease Investigator Group
2002-2018
(Based on Publications as of September 2018)
Alvina Pauline D. Santiago, MD
September 2018
#PEDIG (c) APSantiago 2018

http://pedig.jaeb.org/Studies.aspx
http://www.abcd-vision.org/amblyopia/ats-pedig.html
#PEDIG(c) APSantiago 2018
http://talleyeyecare.com

Amblyopia Definition
Gunter K von Noorden
• Unilateral or bilateral decrease in
VA
• caused by pattern vision
deprivation (lack of adequate
vision stimulation) or abnormal
binocular interaction
• no cause can be detected by
physical examination
• reversible by therapeutic
measures
http://www.ascrs.org
vonNoorden GK. Amblyopia. A Multidisciplinary Approach.
Proctor Lecture. IOVS; 1985; 26: 1704-16
#PEDIG
(c) APSantiago 2018

Definition of Terms: PEDIG
•Amblyopia
• Mild: 20/25 to < 20/40
• Moderate: 20/40 to 20/100 ATS-1, -8, -9
20/40 to 20/80 ATS-2B, -4, 10
• Severe: 20/100 to 20/400 ATS-2A

Amblyopia Treatment Study-1 (ATS-01)
Atropine vs part-time patch, moderate amblyopia
I. Arch Ophthalmol 2002: 120(3) 268-278
II. Arch Ophthalmol 2002: 120 (3) 281-287
III. Arch Ophthalmol 2003: 121 (11): 1625-32
IV. Arch Ophthalmol 2005: 123 (2): 149-157
V. J AAPOS 2005: 9 (6): 542-545
VI. Arch Ophthalmol 2008: 1039-1044
VII. JAMA Ophthalmol. 2014 July ; 132(7): 799–805
VIII. Arch Ophthalmol 2002: 120(3) 268-278

 3-7 years
 >/= 3 lines 79%P, 74%A
 Atropine better acceptability
 Strabismic=anisometropic amblyopia
 2 yr follow-up, after 6 months treatment,
both 2 lines behind
 Same rates of deterioration &
improvement
 New strabismus resolved with cessation
of treatment (18%P, 16%A)

10 & 15 years follow-up
• improvement maintained
• residual amblyopia common
http://www.ibeta.com
Arch Ophthalmol 2008: 1039-1044;
JAMA Ophthalmol. 2014 July ; 132(7): 799–805
http://logopond.com/

(6h vs full; 2h vs 6h)
• I. Ophthalmology 2003: 110(11) 2075-2087
• II. Arch Ophthalmol 2003: 121 (5) 603-611
• III. J AAPOS 2004: 8(5): 420-428
https://upload.wikimedia.org
https://www.hosteurope.de https://blog.logos.com

Amblyopia Treatment Study-2A (ATS-2A)
Patch 6 hrs vs full time, severe amblyopia
• Full time: all waking hrs minus 1 hour off
• Severe amblyopia: 20/100-20/400
• Age 3-7 years
• After 4 months
• 4.8 lines in 6 hrs group; vs 4.7 in full time
http://oceansignal.com
Ophthalmology 2003: 110(11) 2075-2087

Amblyopia Treatment Study-2B (ATS-2B)
Patch 2 hrs (minimal time) vs 6 hrs (part time) for Moderate amblyopia
• moderate: 20/40-20/80
• ages 3-7 years
• At 4 months: 2.4 lines in both groups with 1 hr of
near visual activity
https://www.hosteurope.de
https://upload.wikimedia.org
Arch Ophthalmol 2003: 121 (5) 603-611
#PEDIG
(c) APSantiago 2018

Amblyopia Treatment Study-2C (ATS-2C)
Recurrence after cessation of patching / Atropine
• younger than age 8
• 3 months of amblyopia treatment
• Recurrence same
• 24% of patched patients;
• 21% of atropinized
• 1/4 experience recurrence within
1st year of cessation
• RCT for weaning vs. no-weaning
J AAPOS 2004: 8(5): 420-428

7 to < 18: spectacles vs atropine/patch
• Arch Ophthalmol 2005: 123: 437-477 (Control)
• Am J Ophthalmol 2004: 137: 581-583 (10-18yrs)
• Arch Ophthalmol 2007: 125: 655-659
http://cdn4.teen.com

• ages 7-17 years
• 20/40-20/400
• Given optimal optical
correction then randomized
• Tx: glasses, patch plus near
activity, atropine
• No Tx: glasses alone
Arch Ophthalmol 2005: 123: 437-477 (Control)
Am J Ophthalmol 2004: 137: 581-583 (10-18yrs)
Arch Ophthalmol 2007: 125: 655-659

• Responders: improved > 10 letters / 2 lines
• Improves with glasses alone in 25%
• Most patients left with residual VA deficit
• Ages 7-12: tx improved amblyopia even if previously
treated
• Ages 13-17: tx improved if no previous tx for
amblyopia
• Unknown: if treatment results robust http://cdn4.teen.com
Arch Ophthalmol 2005: 123: 437-477 (Control)
Am J Ophthalmol 2004: 137: 581-583 (10-18yrs)
Arch Ophthalmol 2007: 125: 655-659

Atropine weekend vs daily; moderate amblyopia
• 20/40-20/80
• ages 3-7 years
• Similar results with
weekend atropine vs daily
atropine
• 2.3 lines in both groups
https://thejobshop.files.wordpress.com
Ophthalmology 2004: 111: 2076-2085

3 to < 7y, spectacles alone
• amblyopia improved with glasses by
> 2 lines in 77%
• amblyopia resolved in 27% with
glasses alone
• 3 line improvement average
• Lessen the burden of amblyopia
therapy
Ophthalmology 2006: 113 (6) 895-903.

spectacles first then patch 2 hrs vs spectacles, 20/40-20/400
o Strabismic &anisometropic amblyopia
o 2 hrs (1 hr near activity) + specs vs. specs alone
• At 5 wks: 1.1 lines improvement for treated; 0.5 lines for
specs alone
• Any visit average: 2.2 lines treated; 1.1 lines specs
• After glasses, 2 hrs patching (with 1 hr near activity)
improves moderate to severe amblyopia
https://t2.ftcdn.net
✚

3 to <7, patch 2 hrs with near vs far activities after spectacles
• Pilot: 4 wks: suggestion of
greater improvement in
amblyopic eye with near
activities prescribed
• 2.6 lines near; 1.6 lines far (p=0.07)
http://www.adventuresetup.com
http://glacialblog.com
J AAPOS 2005: 9: 129-136

(VA 20/40 to 20/400)
• At 8 wks: improvement in
amblyopic eye
• Distance activity: 2.6 lines
• Near activity: 2.5 lines 2.6 lines
near; 1.6 lines far (p=0.07)
• Similar for both groups, even at 2,
5, 17 wks.
http://s7.photobucket.com
Ophthalmology 2008; 115: 2071-78

(VA 20/40 to 20/400)
• 3.6 lines improvement in severe amblyopic
group
• Adding near activities did not improve VA
outcome in anisometropic, strabismic,
combined amblyopia with 2 hrs of daily
patching
• Severe amblyopia can respond even to 2 hrs of
daily patching
http://www.getbettergradesnow.com
Ophthalmology 2008; 115: 2071-78

Bilateral refractive amblyopia 20/40-20/400; specs x 1 yr
(Response to treatment of previously untreated presumed
bilateral refractive amblyopia)
• less than 10 years old
• Hypermetropia > 4.0D;
• astigmatism > 2.0D
• Eyeglasses alone improves
binocular VA to 20/25 or better
within 1 year
Am J Ophthalmol 2007: 144: 487-496

• Age 7-12; moderate amblyopia
20/40-20/100
• similar degrees of improvement
• About 1 in 5 achieved VA of 20/25 or
better in the amblyopic eye.
• Atropine and patching achieved
similar results among older children
with unilateral amblyopia
(7 to <13, ATS-1: weekend atropine vs. patch 2hours
http://dissurat.net
https://t2.ftcdn.net
Arch Ophthalmol. 2008;126(12):1634-1642

Bangerter filters vs. patching
• moderate amblyopia 20/40-20/80; 3-<10y.
• At 24 wks, 1.9 lines improvement with Bangerter,
vs.2.3 lines in patching group
• Average difference in vision improvement between
Bangerter filters and patching was less than half a
line
• ower burden of treatment on the child and family,
Bangerter filter treatment is a reasonable option
to consider for initial treatment of moderate
amblyopia.
Ophthalmology 2010;117:998-1004. |
#PEDIG (c) APSantiago 2018 23

ATS 13: An Observational Study of Optical
Correction for Strabismic & Combined
Strabismic Anisometropic Amblyopia in
Children 3 to < 7 years old
• VA after 18 weeks improved mean of 2.6 lines
• 75% > 2 lines, 54% > 3 lines
• Resolution of amblyopia in 32%
• Greater in Strabismic Amblyopia alone
(3.2 vs 2.3 lines)
• VA improved regardless of whether alignment
better
• Optical treatment alone results in clinically meaningful
improvement;
• may consider as primary sole initial treatment
Ophthalmology 2012; 119: 150-158. Epub 2011 Sep 29.

ATS 15: Increasing patching for amblyopia study
from 2 to 6 hours
(3 to <8, 20/50 to 20/400)
• When amblyopic eye VA stops improving with 2 hours of
daily patching, increasing the daily patching dosage to 6
hours results in more improvement in VA after 10 weeks
compared with continuing 2 hours daily.
Pediatric Eye Disease Investigator Group. A randomized trial of increasing patching for amblyopia.
Ophthalmology 2013 Nov;120(11):2270-7. Epub 2013 Jun 4

Amblyopia Treatment Study-17 (ATS-
17)
Levodopa for Residual Amblyopia
• 7-12y, 20/50 to 20/400 with patching
• 139 children 7-12 years old
• Strabismic &/or anisometropic amblyopia
• Pilot showed improvement at 4 weeks
• But study at 18 weeks: placebo = levodopa
Ophthalmology. 2015 May;122(5):874-819
Repka MX, Kraker RT, Beck RW, et. al., Pediatric Eye Disease Investigator Group. Pilot study of levodopa dose as treatment for
residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol 2010;128(9):1215-7.

What more PEDIG?
http://www.imore.com
http://www.geek.com
http://www.cclonline.com/
http://icons.iconarchive.com

Binocular Computer Studies for Amblyopia
Ended May 2016
• To compare the effectiveness of 1 hour/day of binocular
game play 7 days per week (minimum of 4 days per week)
with 2 hours/day of patching 7 days per week, in children 5
to <13 years of age (younger cohort), as a non-inferiority
study.
• To compare the effectiveness of 1 hour/day of binocular
game play 7 days per week (minimum of 4 days per week)
with 2 hours/day of patching 7 days per week, in children
13 to <17 years of age (older cohort), as a superiority study.

Binocular iPAD game vs patching (5-12)
• Non inferiority RCT
• 16 wk trial
• iPAD improved 1.05 lines vs patching 1.35 lines
• primary noninferiority analysis was indeterminate
• a post hoc analysis suggested that VA improvement with iPad not as
good as with 2 hours of prescribed daily patching.
Holmes et al … PEDIG. Effect of a binocular iPad game versus part-time
patching in children aged 5 to 12 with amblyopia: a randomized clinical
trial. JAMA Ophthalmol 2016;134(12)

Binocular iPAD game vs patching (13 to <17)
• Amblyopia 20/40 to 20/200
• 16 wks of iPAD 1 h game or patching 2h/day
• 3.5 letters in iPAD group vs. 6.5 letters in patching group
• Even in the iPAD group, only 13% of patients completed >75% of
prescribed treatment
• PATCHING still better, iPAD possibly worse
• Compliance vs lack of treatment effect?
Manh VM, Holmes JM, Lazar EL, et al and Pediatric Eye Disease Investigator Group. A
Randomized Trial Of A Binocular iPad Game Versus Part-Time Patching In Children 13
To 16 Years Of Age With Amblyopia. Am J Ophthalmol 2018;186:104-15.

Non PEDIG RCTs
https://www.aao.org

Non PEDIG RCTs
https://www.aao.org
• 3-8 y, 20/40 to 20/100
• Glasses x 12 wks, no improvement
• Occluded 50% x 4h vs Patching 2h
• Not inferior to patching
• Alternative for treatment

Excimer Laser Surgery for Anisometropic Amblyopia
• Upcoming
• To compare the efficacy and safety of surgical
treatment (PRK) versus non-surgical treatment
of anisometropic amblyopia in children who
have failed conventional treatment due to non-
compliance or non-response.

Binocular Dig Rush Game for Amblyopia
• Recruiting
• 1 hour/day of binocular game play 5 days per
week plus spectacle correction vs. spectacle
correction only
• for treatment of amblyopia
• children 4 to <13 years of age.
https://www.ophth.wisc.edu/blog/2018/02/12/binocular-dig-
rush-game-treatment-amblyopia/

Recap: Lessons learned from PEDIG
1. Atropine = patching
• 3-7 years old, 20-40 to 20/100
• Anisometropic and strabismic amblyopia
• Long-term follow-up 10y and 15y same
• New strabismus can develop in either by 2
years 16-18%,
• Resolved at cessation of therapy
• Residual amblyopia common
• 7-12y, 20/40 to 20/100
• 1 in 5 achieved > 20/25

2. 6 hours = full time
• 3-7 years old
• Severe amblyopia 20/100-20/400
3. 2 = 6 hours
• 3-7 years old
• Moderate amblyopia 20/40 to 20/80

4. Amblyopia improves with glasses alone.
• 20/40 to 20/400, 7-17y (25%)
• 3 to <7, 20/40 to 20/400
• Resolved in 27%
• Improved in 77%
• Better improvement in strabismic than
combined strabismic and amblyopic
amblyopia
• Less than 10y, 20/40 to 20/400
• Bilateral refractive amblyopia VA > 20/25 in
a year
AP Santiago MD 2017

5. Atropine and/or patching can be added
after glasses.
• Moderate to severe amblyopia 20/40 to
20/400, 7 to <18
6. Add patching after glasses given time to
work.
• Moderate to severe amblyopia: 20/40 to 20/400
• 3 to <7y, 2h patch (1 hr near)
• 7-12 even if previously treated
• 13 to <18 if no previous treatment

7. Daily = weekly atropine
• 3-7 years
• Moderate amblyopia: 20/40 to 20/80
8. Near = Far
• 3-7 years
• moderate to severe amblyopia: 20/40 to
20/400
AP Santiago MD 2017

Lessons learned from PEDIG Studies
9. Severe amblyopia can improve even with 2 h of
patching
• 3-7 years, 20/40 to 20/400
10.Bangerter filter a reasonable option.
• 3 to <10, 20/40 to 20/80
• Not better than patching
• More acceptable
11.Patching 2h/d better than binocular iPAD
• 5-<13, 13 to <17
• 20/40 to 20/200

Lessons learned from PEDIG Studies
12. Intensive final push with atropine and patch not
effective.
13.Levodopa same as placebo.
• 8-17y, already on patching
14.6h >2h: Increasing 2 to 6 hours can improve
amblyopia
• 3 to <8m 20/50 to 20/400
• if plateau with 2 hours reached
15.Plano lenses don’t work.
16.Standardizing vision therapy unsuccessful.

What the future holds
• Laser refractive correction as a viable option for
anisometropic amblyopia
• Others options
• Virtual reality games
• Smart glasses
• Dichoptic movie viewing
AP Santiago MD 2017

Virtual Reality Games for Amblyopia
❖ 0:33 The Oculus Rift
❖ 0.38 – 1:29 How it Works
https://www.youtube.com/watch?v=KumScsJ0xNQ

Amblyopia Glasses
VIDI SMART GLASSES AMBLYZ AMBLYOPIA GLASSES
http://eyepatch.com.au/product/Vidi-Smart-Glasses
https://www.aao.org

Every closed eye is not sleeping, and every open eye is not seeing.
-- Bill Cosby
#PEDIG(c) APSantiago 2018

2018 pedig amblyopia v1

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2018 pedig amblyopia v1