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Amblyopia Treatment
Studies
Pediatric Eye Disease Investigator Group
2002-2016
(Publications as of September 13, 2016)
Alvina Pauline D. Santiago, MD
September 2016
http://pedig.jaeb.org/Studies.aspx
http://www.abcd-vision.org/amblyopia/ats-pedig.html
AP Santiago MD 2016
http://talleyeyecare.com
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
AP Santiago MD 2016
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch, moderate
amblyopia
  I. Arch Ophthalmol 2002: 120(3)
268-278
  VA 20/40-20/100
  3 or more lines:
  Atropine (74%) & Patching
(79%)
  Atropine & patching similar for
age 3-7 yr
  Atropine better acceptability
AP Santiago MD 2016
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch,
moderate amblyopia
  II. Arch Ophthalmol 2002:
120 (3) 281-287
  Clinical profile of moderate
amblyopia subjects
  moderate amblyopia
20/40-20/100
  7 yrs and below
  Same effect for strabismic
and anisometropic amblyopia
AP Santiago MD 2016
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch, moderate
amblyopia
  III. Arch Ophthalmol 2003: 121
(11): 1625-32
  Impact of patching vs atropine
  Both well tolerated by child and
family
  Atropine more favorable
AP Santiago MD 2016
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch,
moderate amblyopia
  IV. Arch Ophthalmol 2005: 123
(2): 149-157
  2 yr follow up after 6 month of
patching or atropine
  Similar results in both groups
  Amblyopic eye still 2 lines worse
than sound eye
AP Santiago MD 2015
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch,
moderate amblyopia
  V. J AAPOS 2005: 9 (6): 542-545
  Effect of amblyopia tx on ocular alignment
  Same rates of deterioration or improvement
in both groups
  New strabismus by 2 yrs: most resolved after
cessation of treatment
  18% in patching: 2 greater than 8PD
  16% in atropine: 3 greater than 8PD
AP Santiago MD 2015
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch,
moderate amblyopia
  VI. Arch Ophthalmol 2008:
1039-1044
  10 year follow up
  improvement of amblyopia
maintained
  Outcome similar for both
groups
  residual amblyopia common
  treatment initiated at age
3-7 years
AP Santiago MD 2015
http://www.ibeta.com
Amblyopia Treatment
Study-1 (ATS-1)
Atropine vs part-time patch,
moderate amblyopia
  VII. JAMA Ophthalmol.
2014 July ; 132(7): 799–805
  15 year follow up
  improvement of amblyopia
maintained
  Outcome similar for both
groups
  Mild residual amblyopia
common
  treatment initiated at age
3-7 years
AP Santiago MD 2015
http://logopond.com/
Amblyopia Treatment Study-2 (ATS-2)
(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
AP Santiago MD 2015
https://www.hosteurope.de
https://upload.wikimedia.org
https://blog.logos.com
Amblyopia Treatment Study-2A (ATS-2A)
Patch 6 hrs vs full time, severe amblyopia
  I. Ophthalmology 2003: 110(11) 2075-2087
  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
AP Santiago MD 2015
http://oceansignal.com
http://oceansignal.com
Amblyopia Treatment Study-2B (ATS-2B)
Patch 2 hrs (minimal time) vs 6 hrs (part time)
for Moderate amblyopia
  II. Arch Ophthalmol 2003: 121 (5) 603-611
  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
AP Santiago MD 2015
https://www.hosteurope.de
https://upload.wikimedia.org
http://oceansignal.com
Amblyopia Treatment
Study-2C (ATS-2C)
Recurrence after cessation of
patching / Atropine
  III. J AAPOS 2004: 8(5): 420-428
  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
AP Santiago MD 2015
Amblyopia Treatment Study-3 (ATS-3)
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
AP Santiago MD 2015
http://cdn4.teen.com
http://cdn4.teen.com
Amblyopia Treatment Study-3 (ATS-3)
7 to < 18: spectacles vs atropine/patch
  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
AP Santiago MD 2015
http://cdn4.teen.com
Amblyopia Treatment Study-3 (ATS-3)
7 to < 18: spectacles vs atropine/patch
  Responders: improved by >/= 10 letters / 2
lines
  Amblyopia improves with Rx 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 (if it will
stay)
AP Santiago MD 2015
http://cdn4.teen.com
Amblyopia Treatment Study-4 (ATS-4)
Atropine weekend vs daily; moderate amblyopia
  Ophthalmology 2004: 111:
2076-2085
  20/40-20/80
  ages 3-7 years
  Similar results with weekend
atropine vs daily atropine
  2.3 lines in both groups
AP Santiago MD 2015
https://thejobshop.files.wordpress.com
Amblyopia Treatment Study-5 (ATS-5)
3 to < 7, spectacles alone vs patch 2 hrs + spectacles
  Ophthalmology 2006: 113 (6) 895-903.
  amblyopia improved with Rx by >/= 2
lines in 77%
  amblyopia resolved in 27% with Rx
alone
  3 line improvement average
  Lessen the burden of amblyopia therapy
AP Santiago MD 2015
http://cdn4.teen.com
Amblyopia Treatment
Study-5 (ATS-5)
3 to <7, spectacles alone,
then patch 2 hrs vs spectacles
Ophthalmology 2006: 113 (6) 904-912.
•  Strabismic and anisometropic amblyopia
•  20/40-20/400
•  2 hrs (1 hr near activity) + specs vs. specs alone
AP Santiago MD 2015
Amblyopia Treatment Study-5 (ATS-5)
spectacles alone, then patch 2 hrs vs spectacles
  Ophthalmology 2006: 113 (6)
904-912.
  5 wks: 1.1 lines treated; 0.5
lines specs
  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
AP Santiago MD 2015
https://t2.ftcdn.net
✚http://cdn4.teen.com
Amblyopia Treatment Study-6 (ATS-6)
3 to <7, patch 2 hrs with near vs far activities after spectacles
  J AAPOS 2005: 9: 129-136
  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)
AP Santiago MD 2015
http://www.adventuresetup.com
http://glacialblog.com
Amblyopia Treatment
Study-6 (ATS-6)
3 to <7, patch 2 hrs with near vs far
activities after spectacles
(VA 20/40 to 20/400)
AP Santiago MD 2015
  Ophthalmology 2008; 115: 2071-78
  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
Amblyopia Treatment Study-6 (ATS-6)
3 to <7, patch 2 hrs with near vs far activities after spectacles
(VA 20/40 to 20/400)
AP Santiago MD 2015
  Ophthalmology 2008; 115: 2071-78
  3.6 lines improvement in severe amblyopic group
  Near activities do 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
Amblyopia Treatment Study-7 (ATS-7)
Bilateral refractive amblyopia; specs x 1 yr
(Response to treatment of previously untreated presumed bilateral
refractive amblyopia)
  Am J Ophthalmol 2007: 144: 487-496
  20/40-20/400
  less than 10 years
Hypermetropia >/= 4.0D;
astigmatism >/= 2.0D
  Eyeglasses alone improves binocular
VA to 20/25 or better within 1 year
AP Santiago MD 2015
http://cdn4.teen.com
Amblyopia Treatment Study-8 (ATS-8)
3 to <7, atropine vs Atropine plus plano lens to sound eye
  Arch Ophthalmol 2009;127(1):
22-30
  Moderate amblyopia .
20/40-20/100
  Weekend atropine plus plano
lens = atropine alone
AP Santiago MD 2015
http://dissurat.net
Amblyopia Treatment Study-9 (ATS-9)
(7 to <13, ATS-1: weekend atropine vs. patch 2hours
  Arch Ophthalmol. 2008;126(12):
1634-1642
  Age 7-12; moderate amblyopia
20/40-20/100
  Treatment with atropine or patching led to
similar degrees of improvement among 7-
to 12-year-olds with moderate amblyopia.
About 1 in 5 achieved visual acuity of
20/25 or better in the amblyopic eye.
  Atropine and patching achieve similar
results among older children with
unilateral amblyopia
AP Santiago MD 2015
http://dissurat.net
https://t2.ftcdn.net
Amblyopia Treatment Study-10 (ATS-10)
Bangerter filters vs. patching
  Ophthalmology 2010;117:998-1004. |
  moderate amblyopia 20/40-20/80; 3-<10y.
  At 24 wks, 1.9 lines improvement with Bangerter, vs.2.3 lines
in patching group
  Because the average difference in visual acuity improvement
between Bangerter filters and patching was less than half a
line, and there was lower burden of treatment on the child
and family, Bangerter filter treatment is a reasonable option
to consider for initial treatment of moderate amblyopia.
AP Santiago MD 2015
ATS 11: A randomized trial to evaluate combined
patching-atropine treatment for residual amblyopia
  Evaluate effectiveness of treatment of residual
amblyopia in 3-10y
  VA 20/32 to 20/63 (mild residual amblyopia)
  RCT: intensive treatment vs. rapid weaning plus glasses
  Intensive: (42 hrs weekly dose plus daily atropine)
Pediatric Eye Disease Investigator Group. Randomized trial to evaluate combined patching and atropine for residual amblyopia.
Arch Ophthalmol 2011;129(7):960-2.
AP Santiago MD 2015
http://www.clipartbest.com
ATS 11: A randomized trial to evaluate combined
patching-atropine treatment for residual amblyopia
  Intensive final push of combined treatment with patching
and daily atropine did not produce a better visual acuity
outcome after 10 weeks
  Compared with a control group in whom treatment was
gradually discontinued
AP Santiago MD 2015
http://www.clipartbest.com
ATS 11: A randomized trial to evaluate combined
patching-atropine treatment for residual amblyopia
  The study was stopped on recommendation of
the data and safety monitoring committee
  slow recruitment
  conditional power analysis indicating that the
study was unlikely to find a statistically
significant benefit
AP Santiago MD 2015
ATS 12: A randomized trial comparing patching with
active vision therapy to patching with control vision
therapy as treatment for amblyopia in children
7 to < 13 years old
  Lyon DW, Hopkins K, Chu RH et al. Feasibility of a
clinical trial of vision therapy for treatment of
amblyopia. Optom Vis Sci 2013; 90(5): 475-481.
  16 week vision therapy feasible
  Standardizing approach to vision therapy not successful
AP Santiago MD 2015http://alderwoodvisiontherapy.com
ATS 13: An Observational Study of Optical
Correction for Strabismic Amblyopia in
Children 3 to < 7 years old
  Optical Treatment of Strabismic and Combined Strabismic
Anisometropic Amblyopia. Ophthalmology 2012; 119:
150-158. Epub 2011 Sep 29.
  VA after 18 weeks improved mean of 2.6 lines
  75% >/= 2 line, 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
for this group
AP Santiago MD 2015
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
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.
AP Santiago MD 2015
https://encrypted-tbn1.gstatic.com
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
  At the time of enrollment, subjects
were required to have been treated
with at least 2 hours per day of daily
patching
  And stable visual acuity
  defined as less than 5 letters or one
logMAR line of improvement since a
previous visit at least 8 weeks earlier.
AP Santiago MD 2015
https://www.hosteurope.de
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
  Intervention:
  continuing 2 hours of daily patching
  addition of levodopa in one of two doses
randomly assigned with equal probability
(0.51 or 0.76 mg/kg/tid, referred to as
lower dose and higher dose, respectively).
AP Santiago MD 2015
https://www.hosteurope.de✚
LEVODOPA
+
CARBIDOPA
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
  Intervention:
  The study medication was administered for 8 weeks with
one additional week for tapering of treatment.
  Levodopa was prepared in capsules combined with
carbidopa 0.17 mg/kg/tid.
Carbidopa was combined with levodopa to reduce side-
effects associated with levodopa alone.
AP Santiago MD 2015
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
  The mean improvement in amblyopic eye in 9-
week primary outcome visit was
  +4 (±4) letters in the 16 subjects in the lower dose
group and
  +6 (±6) letters in the 17 subjects in the higher dose
group
AP Santiago MD 2015
ATS 14: A Pilot Study to evaluate levodopa as
treatment for residual amblyopia in 8-17 years old
  An improvement of 10 or more letters noted in 2 (13%)
in low dose, and 5 (29%) in high dose group at 9 wks
  Fellow eye improved 1 letter in high dose and zero letter
is low dose group
  Justification: Small sample, experience with drug,
promising result
AP Santiago MD 2015
ATS 15: Increasing patching for amblyopia study
from 2 hours 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
AP Santiago MD 2015
  David K. Wallace, MD, MPH1; Elizabeth
L. Lazar, MSPH2; Earl R. Crouch III, MD3; Darren
L. Hoover, MD4; Raymond T. Kraker, MSPH2; Susanna
M. Tamkins, OD;
for the Pediatric Eye Disease Investigator Group. Time
course and predictors of amblyopia improvement with 2
hours of daily patching. JAMA Ophthalmol. 2015;133(5):
606-609. doi:10.1001/jamaophthalmol.2015.6.
AP Santiago MD 2015
ATS 15: Increasing patching for amblyopia study
from 2 hours to 6 hours
(3 to <8, 20/50 to 20/400)
ATS 16: Augmenting atropine treatment for
amblyopia with plano lens to sound eye
3 to <8, 20/50 to 20/400
  Objective:
evaluate the effectiveness of adding a plano lens to weekend
atropine in patients with amblyopia still present after visual
acuity has stabilized with initial treatment.
  Children ages 3 to <8 years with visual acuity of 20/50 to
20/400 in the amblyopic eye will be enrolled in a run-in
phase with weekend atropine until no improvement,
  followed by randomization of eligible patients to weekend
atropine treatment with a plano lens over the sound eye
versus without a plano lens over the sound eye.
AP Santiago MD 2015
  Objective:
evaluate the effectiveness of adding a plano lens to weekend
atropine in patients with amblyopia still present after visual
acuity has stabilized with initial treatment.
  Children ages 3 to <8 years with visual acuity of 20/50 to
20/400 in the amblyopic eye will be enrolled in a run-in phase
with weekend atropine until no improvement,
  followed by randomization of eligible patients to weekend
atropine treatment with a plano lens over the sound eye versus
without a plano lens over the sound eye.
AP Santiago MD 2015
J AAPOS 2015;19:42-48
ATS 16: Augmenting atropine treatment for
amblyopia with plano lens to sound eye
3 to <8, 20/50 to 20/400
  Results:
atropine + plano lens = atropine only
  1.1 vs 0.6, not statistically significant
  Conclusion:
  Small benefit to adding plano lens
  Larger study recommended
AP Santiago MD 2015
J AAPOS 2015;19:42-48
ATS 16: Augmenting atropine treatment for
amblyopia with plano lens to sound eye
3 to <8, 20/50 to 20/400
Amblyopia Treatment Study-17 (ATS-17)
Levodopa for Residual Amblyopia
Ophthalmology. 2015 May;122(5):874-819
  Objective: efficacy and short term safety of levopopa as
adjunctive treatment to amblyopia
  139 children 7-12 years old
Strabismic &/or anisometropic amblyopia
  Residual 20/50-20/400 with patching
AP Santiago MD 2015
Amblyopia Treatment Study-17 (ATS-17)
Levodopa for Residual Amblyopia
  Intervention: 16 weeks while patching 2h/d
  oral levodopa (oral levodopa 0.76 mg/kg with carbidopa 0.17
mg/kg ) vs placebo TID
  Results: at 18 weeks
  Levodopa = placebo (5.2 vs 3.8 letters=not statistically
significant)
  No adverse effect from levodopa
AP Santiago MD 2015
What more PEDIG?
http://www.imore.com
http://www.geek.com
http://www.cclonline.com/
http://icons.iconarchive.com AP Santiago MD 2015
Amblyopia Treatment Study-18 (ATS-18)
Binocular Computer Activities for Treatment of Amblyopia
REVIEW of LITERATURE
  Li J, Thompson B, Deng D, Chan LY, Yu M, Hess RF. Dichoptic training enables the adult 1080
amblyopic brain to learn. Curr Biol 2013;23:R308-9. 1081
  Hess RF, Thompson B, Black JM, et al. An iPod treatment of amblyopia: an updated 1082 binocular
approach. Optometry 2012;83:87-94. 1083
  To L, Thompson B, Blum JR, Maehara G, Hess RF, Cooperstock JR. A game platform for 1084
treatment of amblyopia. IEEE Trans Neural Syst Rehabil Eng 2011;19:280-9. 1085
  Li SL, Jost RM, Morale SE, et al. A binocular iPad treatment for amblyopic children. Eye (2014) 28,
1246–1253; doi:10.1038/eye.2014.165; published online 25 July 2014.
  Li SL, Jost RM, Morale SE, et al. Binocular iPad Treatment of Amblyopia for Lasting Improvement of
Visual Acuity. JAMA Ophthalmol. 2015;133(4):479-480. doi:10.1001/jamaophthalmol.2014.5515.
  Birch EE, Li S, Jost RM, et al. Binocular iPad treatment for amblyopia in preschool 1088 children. J
AAPOS 2014 AAPOS. 1089
AP Santiago MD 2015
Amblyopia Treatment Study-18 (ATS-18)
Binocular Computer Activities for Treatment of Amblyopia
Ended May 2, 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.
AP Santiago MD 2015
Lessons learned from PEDIG Studies
1.  Atropine = patching
2.  6 hours = full time
3.  2 = 6 hours
4.  Amblyopia improves with glasses alone.
5.  Add patching after glasses given time to work.
AP Santiago MD 2015
Lessons learned from PEDIG Studies
6.  Spectacles and patching even for 13-17.
7.  Daily = weekly
8.  Near = Far
9.  Severe amblyopia can improve even with 2 h of patching
10.  Bangerter filter = patching
AP Santiago MD 2015
Lessons learned from PEDIG Studies
11.  Intensive final push with atropine and patch not effective.
12.  Levodopa promising but same as placebo.
13.  6h >2h: Increasing 2 to 6 hours can improve amblyopia
(if plateau with 2 hours reached).
14.  Plano lenses don’t work.
AP Santiago MD 2015
Every closed eye is not sleeping, and every
open eye is not seeing.
-- Bill Cosby

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2016 Amblyopia PEDIG Studies

  • 1. Amblyopia Treatment Studies Pediatric Eye Disease Investigator Group 2002-2016 (Publications as of September 13, 2016) Alvina Pauline D. Santiago, MD September 2016
  • 3. 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 AP Santiago MD 2016
  • 4. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   I. Arch Ophthalmol 2002: 120(3) 268-278   VA 20/40-20/100   3 or more lines:   Atropine (74%) & Patching (79%)   Atropine & patching similar for age 3-7 yr   Atropine better acceptability AP Santiago MD 2016
  • 5. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   II. Arch Ophthalmol 2002: 120 (3) 281-287   Clinical profile of moderate amblyopia subjects   moderate amblyopia 20/40-20/100   7 yrs and below   Same effect for strabismic and anisometropic amblyopia AP Santiago MD 2016
  • 6. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   III. Arch Ophthalmol 2003: 121 (11): 1625-32   Impact of patching vs atropine   Both well tolerated by child and family   Atropine more favorable AP Santiago MD 2016
  • 7. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   IV. Arch Ophthalmol 2005: 123 (2): 149-157   2 yr follow up after 6 month of patching or atropine   Similar results in both groups   Amblyopic eye still 2 lines worse than sound eye AP Santiago MD 2015
  • 8. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   V. J AAPOS 2005: 9 (6): 542-545   Effect of amblyopia tx on ocular alignment   Same rates of deterioration or improvement in both groups   New strabismus by 2 yrs: most resolved after cessation of treatment   18% in patching: 2 greater than 8PD   16% in atropine: 3 greater than 8PD AP Santiago MD 2015
  • 9. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   VI. Arch Ophthalmol 2008: 1039-1044   10 year follow up   improvement of amblyopia maintained   Outcome similar for both groups   residual amblyopia common   treatment initiated at age 3-7 years AP Santiago MD 2015 http://www.ibeta.com
  • 10. Amblyopia Treatment Study-1 (ATS-1) Atropine vs part-time patch, moderate amblyopia   VII. JAMA Ophthalmol. 2014 July ; 132(7): 799–805   15 year follow up   improvement of amblyopia maintained   Outcome similar for both groups   Mild residual amblyopia common   treatment initiated at age 3-7 years AP Santiago MD 2015 http://logopond.com/
  • 11. Amblyopia Treatment Study-2 (ATS-2) (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 AP Santiago MD 2015 https://www.hosteurope.de https://upload.wikimedia.org https://blog.logos.com
  • 12. Amblyopia Treatment Study-2A (ATS-2A) Patch 6 hrs vs full time, severe amblyopia   I. Ophthalmology 2003: 110(11) 2075-2087   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 AP Santiago MD 2015 http://oceansignal.com http://oceansignal.com
  • 13. Amblyopia Treatment Study-2B (ATS-2B) Patch 2 hrs (minimal time) vs 6 hrs (part time) for Moderate amblyopia   II. Arch Ophthalmol 2003: 121 (5) 603-611   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 AP Santiago MD 2015 https://www.hosteurope.de https://upload.wikimedia.org http://oceansignal.com
  • 14. Amblyopia Treatment Study-2C (ATS-2C) Recurrence after cessation of patching / Atropine   III. J AAPOS 2004: 8(5): 420-428   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 AP Santiago MD 2015
  • 15. Amblyopia Treatment Study-3 (ATS-3) 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 AP Santiago MD 2015 http://cdn4.teen.com http://cdn4.teen.com
  • 16. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch   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 AP Santiago MD 2015 http://cdn4.teen.com
  • 17. Amblyopia Treatment Study-3 (ATS-3) 7 to < 18: spectacles vs atropine/patch   Responders: improved by >/= 10 letters / 2 lines   Amblyopia improves with Rx 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 (if it will stay) AP Santiago MD 2015 http://cdn4.teen.com
  • 18. Amblyopia Treatment Study-4 (ATS-4) Atropine weekend vs daily; moderate amblyopia   Ophthalmology 2004: 111: 2076-2085   20/40-20/80   ages 3-7 years   Similar results with weekend atropine vs daily atropine   2.3 lines in both groups AP Santiago MD 2015 https://thejobshop.files.wordpress.com
  • 19. Amblyopia Treatment Study-5 (ATS-5) 3 to < 7, spectacles alone vs patch 2 hrs + spectacles   Ophthalmology 2006: 113 (6) 895-903.   amblyopia improved with Rx by >/= 2 lines in 77%   amblyopia resolved in 27% with Rx alone   3 line improvement average   Lessen the burden of amblyopia therapy AP Santiago MD 2015 http://cdn4.teen.com
  • 20. Amblyopia Treatment Study-5 (ATS-5) 3 to <7, spectacles alone, then patch 2 hrs vs spectacles Ophthalmology 2006: 113 (6) 904-912. •  Strabismic and anisometropic amblyopia •  20/40-20/400 •  2 hrs (1 hr near activity) + specs vs. specs alone AP Santiago MD 2015
  • 21. Amblyopia Treatment Study-5 (ATS-5) spectacles alone, then patch 2 hrs vs spectacles   Ophthalmology 2006: 113 (6) 904-912.   5 wks: 1.1 lines treated; 0.5 lines specs   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 AP Santiago MD 2015 https://t2.ftcdn.net ✚http://cdn4.teen.com
  • 22. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles   J AAPOS 2005: 9: 129-136   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) AP Santiago MD 2015 http://www.adventuresetup.com http://glacialblog.com
  • 23. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles (VA 20/40 to 20/400) AP Santiago MD 2015   Ophthalmology 2008; 115: 2071-78   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
  • 24. Amblyopia Treatment Study-6 (ATS-6) 3 to <7, patch 2 hrs with near vs far activities after spectacles (VA 20/40 to 20/400) AP Santiago MD 2015   Ophthalmology 2008; 115: 2071-78   3.6 lines improvement in severe amblyopic group   Near activities do 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
  • 25. Amblyopia Treatment Study-7 (ATS-7) Bilateral refractive amblyopia; specs x 1 yr (Response to treatment of previously untreated presumed bilateral refractive amblyopia)   Am J Ophthalmol 2007: 144: 487-496   20/40-20/400   less than 10 years Hypermetropia >/= 4.0D; astigmatism >/= 2.0D   Eyeglasses alone improves binocular VA to 20/25 or better within 1 year AP Santiago MD 2015 http://cdn4.teen.com
  • 26. Amblyopia Treatment Study-8 (ATS-8) 3 to <7, atropine vs Atropine plus plano lens to sound eye   Arch Ophthalmol 2009;127(1): 22-30   Moderate amblyopia . 20/40-20/100   Weekend atropine plus plano lens = atropine alone AP Santiago MD 2015 http://dissurat.net
  • 27. Amblyopia Treatment Study-9 (ATS-9) (7 to <13, ATS-1: weekend atropine vs. patch 2hours   Arch Ophthalmol. 2008;126(12): 1634-1642   Age 7-12; moderate amblyopia 20/40-20/100   Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye.   Atropine and patching achieve similar results among older children with unilateral amblyopia AP Santiago MD 2015 http://dissurat.net https://t2.ftcdn.net
  • 28. Amblyopia Treatment Study-10 (ATS-10) Bangerter filters vs. patching   Ophthalmology 2010;117:998-1004. |   moderate amblyopia 20/40-20/80; 3-<10y.   At 24 wks, 1.9 lines improvement with Bangerter, vs.2.3 lines in patching group   Because the average difference in visual acuity improvement between Bangerter filters and patching was less than half a line, and there was lower burden of treatment on the child and family, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia. AP Santiago MD 2015
  • 29. ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia   Evaluate effectiveness of treatment of residual amblyopia in 3-10y   VA 20/32 to 20/63 (mild residual amblyopia)   RCT: intensive treatment vs. rapid weaning plus glasses   Intensive: (42 hrs weekly dose plus daily atropine) Pediatric Eye Disease Investigator Group. Randomized trial to evaluate combined patching and atropine for residual amblyopia. Arch Ophthalmol 2011;129(7):960-2. AP Santiago MD 2015
  • 30. http://www.clipartbest.com ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia   Intensive final push of combined treatment with patching and daily atropine did not produce a better visual acuity outcome after 10 weeks   Compared with a control group in whom treatment was gradually discontinued AP Santiago MD 2015
  • 31. http://www.clipartbest.com ATS 11: A randomized trial to evaluate combined patching-atropine treatment for residual amblyopia   The study was stopped on recommendation of the data and safety monitoring committee   slow recruitment   conditional power analysis indicating that the study was unlikely to find a statistically significant benefit AP Santiago MD 2015
  • 32. ATS 12: A randomized trial comparing patching with active vision therapy to patching with control vision therapy as treatment for amblyopia in children 7 to < 13 years old   Lyon DW, Hopkins K, Chu RH et al. Feasibility of a clinical trial of vision therapy for treatment of amblyopia. Optom Vis Sci 2013; 90(5): 475-481.   16 week vision therapy feasible   Standardizing approach to vision therapy not successful AP Santiago MD 2015http://alderwoodvisiontherapy.com
  • 33. ATS 13: An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to < 7 years old   Optical Treatment of Strabismic and Combined Strabismic Anisometropic Amblyopia. Ophthalmology 2012; 119: 150-158. Epub 2011 Sep 29.   VA after 18 weeks improved mean of 2.6 lines   75% >/= 2 line, 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 for this group AP Santiago MD 2015
  • 34. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old 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. AP Santiago MD 2015 https://encrypted-tbn1.gstatic.com
  • 35. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old   At the time of enrollment, subjects were required to have been treated with at least 2 hours per day of daily patching   And stable visual acuity   defined as less than 5 letters or one logMAR line of improvement since a previous visit at least 8 weeks earlier. AP Santiago MD 2015 https://www.hosteurope.de
  • 36. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old   Intervention:   continuing 2 hours of daily patching   addition of levodopa in one of two doses randomly assigned with equal probability (0.51 or 0.76 mg/kg/tid, referred to as lower dose and higher dose, respectively). AP Santiago MD 2015 https://www.hosteurope.de✚ LEVODOPA + CARBIDOPA
  • 37. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old   Intervention:   The study medication was administered for 8 weeks with one additional week for tapering of treatment.   Levodopa was prepared in capsules combined with carbidopa 0.17 mg/kg/tid. Carbidopa was combined with levodopa to reduce side- effects associated with levodopa alone. AP Santiago MD 2015
  • 38. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old   The mean improvement in amblyopic eye in 9- week primary outcome visit was   +4 (±4) letters in the 16 subjects in the lower dose group and   +6 (±6) letters in the 17 subjects in the higher dose group AP Santiago MD 2015
  • 39. ATS 14: A Pilot Study to evaluate levodopa as treatment for residual amblyopia in 8-17 years old   An improvement of 10 or more letters noted in 2 (13%) in low dose, and 5 (29%) in high dose group at 9 wks   Fellow eye improved 1 letter in high dose and zero letter is low dose group   Justification: Small sample, experience with drug, promising result AP Santiago MD 2015
  • 40. ATS 15: Increasing patching for amblyopia study from 2 hours 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 AP Santiago MD 2015
  • 41.   David K. Wallace, MD, MPH1; Elizabeth L. Lazar, MSPH2; Earl R. Crouch III, MD3; Darren L. Hoover, MD4; Raymond T. Kraker, MSPH2; Susanna M. Tamkins, OD; for the Pediatric Eye Disease Investigator Group. Time course and predictors of amblyopia improvement with 2 hours of daily patching. JAMA Ophthalmol. 2015;133(5): 606-609. doi:10.1001/jamaophthalmol.2015.6. AP Santiago MD 2015 ATS 15: Increasing patching for amblyopia study from 2 hours to 6 hours (3 to <8, 20/50 to 20/400)
  • 42. ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400   Objective: evaluate the effectiveness of adding a plano lens to weekend atropine in patients with amblyopia still present after visual acuity has stabilized with initial treatment.   Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement,   followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. AP Santiago MD 2015
  • 43.   Objective: evaluate the effectiveness of adding a plano lens to weekend atropine in patients with amblyopia still present after visual acuity has stabilized with initial treatment.   Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement,   followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. AP Santiago MD 2015 J AAPOS 2015;19:42-48 ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400
  • 44.   Results: atropine + plano lens = atropine only   1.1 vs 0.6, not statistically significant   Conclusion:   Small benefit to adding plano lens   Larger study recommended AP Santiago MD 2015 J AAPOS 2015;19:42-48 ATS 16: Augmenting atropine treatment for amblyopia with plano lens to sound eye 3 to <8, 20/50 to 20/400
  • 45. Amblyopia Treatment Study-17 (ATS-17) Levodopa for Residual Amblyopia Ophthalmology. 2015 May;122(5):874-819   Objective: efficacy and short term safety of levopopa as adjunctive treatment to amblyopia   139 children 7-12 years old Strabismic &/or anisometropic amblyopia   Residual 20/50-20/400 with patching AP Santiago MD 2015
  • 46. Amblyopia Treatment Study-17 (ATS-17) Levodopa for Residual Amblyopia   Intervention: 16 weeks while patching 2h/d   oral levodopa (oral levodopa 0.76 mg/kg with carbidopa 0.17 mg/kg ) vs placebo TID   Results: at 18 weeks   Levodopa = placebo (5.2 vs 3.8 letters=not statistically significant)   No adverse effect from levodopa AP Santiago MD 2015
  • 48. Amblyopia Treatment Study-18 (ATS-18) Binocular Computer Activities for Treatment of Amblyopia REVIEW of LITERATURE   Li J, Thompson B, Deng D, Chan LY, Yu M, Hess RF. Dichoptic training enables the adult 1080 amblyopic brain to learn. Curr Biol 2013;23:R308-9. 1081   Hess RF, Thompson B, Black JM, et al. An iPod treatment of amblyopia: an updated 1082 binocular approach. Optometry 2012;83:87-94. 1083   To L, Thompson B, Blum JR, Maehara G, Hess RF, Cooperstock JR. A game platform for 1084 treatment of amblyopia. IEEE Trans Neural Syst Rehabil Eng 2011;19:280-9. 1085   Li SL, Jost RM, Morale SE, et al. A binocular iPad treatment for amblyopic children. Eye (2014) 28, 1246–1253; doi:10.1038/eye.2014.165; published online 25 July 2014.   Li SL, Jost RM, Morale SE, et al. Binocular iPad Treatment of Amblyopia for Lasting Improvement of Visual Acuity. JAMA Ophthalmol. 2015;133(4):479-480. doi:10.1001/jamaophthalmol.2014.5515.   Birch EE, Li S, Jost RM, et al. Binocular iPad treatment for amblyopia in preschool 1088 children. J AAPOS 2014 AAPOS. 1089 AP Santiago MD 2015
  • 49. Amblyopia Treatment Study-18 (ATS-18) Binocular Computer Activities for Treatment of Amblyopia Ended May 2, 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. AP Santiago MD 2015
  • 50. Lessons learned from PEDIG Studies 1.  Atropine = patching 2.  6 hours = full time 3.  2 = 6 hours 4.  Amblyopia improves with glasses alone. 5.  Add patching after glasses given time to work. AP Santiago MD 2015
  • 51. Lessons learned from PEDIG Studies 6.  Spectacles and patching even for 13-17. 7.  Daily = weekly 8.  Near = Far 9.  Severe amblyopia can improve even with 2 h of patching 10.  Bangerter filter = patching AP Santiago MD 2015
  • 52. Lessons learned from PEDIG Studies 11.  Intensive final push with atropine and patch not effective. 12.  Levodopa promising but same as placebo. 13.  6h >2h: Increasing 2 to 6 hours can improve amblyopia (if plateau with 2 hours reached). 14.  Plano lenses don’t work. AP Santiago MD 2015
  • 53. Every closed eye is not sleeping, and every open eye is not seeing. -- Bill Cosby