2. PEDIG
• Pediatric Eye Disease Investigator Group: (PEDIG) is a
collaborative network dedicated to facilitating
multicenter clinical research in strabismus, amblyopia
and other eye disorders that affect children.
• The network, which was formed in 1997, is funded by
the National Eye Institute (NEI)
3. In the ATS,
mild to moderate amblyopia VA in the
amblyopic eye of 6/24 or better;
severe amblyopia is VA in the amblyopic
eye of 6/60 to 6/120.
4. Amblyopia Treatment Study ATS 1
• A randomized trial of atropine versus patching for
treatment of moderate amblyopia in children
vs
5. • OBJECTIVES To compare patching and atropine
as treatments for moderate amblyopia in 3 to <7
years old
• STUDY DESIGN 419 childre <7 years with
amblyopia and VA in the range of 6/12 to 6/60 were
assigned to receive either patching or atropine
• MAIN OUTCOME MEASURE: VA in the amblyopic eye
and sound eye after 6 months.
6. RESULTS: 1.VA improved in both groups 3.16 lines in
patching and 2.84 lines in atropine group (mean diff 0.24
lines)
2.VA >6/9 and/or improved by more than 3
lines in 79% in patching and 74% in atropine group
CONCLUSION
CONCLUSION:
=
7. • Study was continued further and VA in the amblyopic
eye and sound eye after 2 years was measured
• RX was at the discretion of the investigator
RESULTS VA improved in both groups: 3.7 lines in
occlusion group
CONCLUSIONS: Atropine or patching for 6 months
followed by best clinical care until 2 years produced
similar improvement of moderate amblyopia. BUT, on
average the amblyopic eye acuity was still
approximately 2 lines worse than the sound eye.
8. Amblyopia Treatment Study ATS 2A,2B
ATS 2A
OBJECTIVE: To compare full-time patching (all hours) to 6 hours
of patching per day, as prescribed treatments for severe
amblyopia in children younger than 7 years
FULL TIME
VS
PART TIME
9. PARTICIPANTS: 175 children <7 years with amblyopia in the range of 6/60
to 6/120
MAIN OUTCOME MEASURE: VA in the amblyopic eye after 4 months
RESULTS : improvement in the amblyopic eye VA from baseline to 4
months averaged 4.8 lines in the 6-hour group and 4.7 lines in the full-
time group
CONCLUSION:
=
FULL TIME PART TIME
10. ATS 2B
OBJECTIVE: To compare 2 hours vs 6 hours of daily patching as
treatments for moderate amblyopia in <7 years
2 HRS VS 6 HRS
11. PARTICIPANTS: 189 children <7 years with amblyopia in the range of
6/12 to 6/24 assigned To 2 hrs or 6 hrs of daily patching
MAIN OUTCOME MEASURE: VA in the amblyopic eye after 4 months.
RESULTS: The improvement in the visual acuity of the amblyopic eye from
baseline to 4 months averaged 2.40 lines in each group
CONCLUSION:
2 HRS = 6 HRS
12. AMBLYOPIA TREATMENT STUDY ATS 3
• OBJECTIVE: To evaluate the effectiveness of treatment of
amblyopia in children aged 7 to 17 years.
• MAIN OUTCOME MEASURE: VA in the amblyopic eye after 6
months
13. • PARTICIPANTS: 507 patients with amblyopic eye visual acuity ranging
from 6/12 to 6/120
Control Group:
• Optical correction only
Active Treatment Group:
•Optical correction
•Patching 2-6 hours daily
•At least 1 hour of near activities daily during patching
•Atropine 1% one drop daily (pts <13 yrs only)
+
14. ATS 3 RESULTS
MODERATE AMBLYOPIA SEVERE AMBLYOPIA
7-13 YRS 13-17 YRS 7-13 YRS 13-17 YRS
36%achieved
6/7.5 or better
combined
group with 14%
with optical
correction
alone
14% achieved
6/7.5 or better
with optical
correction/occlu
sion compared
with 11% with
optical
correction alone
14% achieved
6/7.5 or better
with optical
correction/occlu
sion compared
with 11% with
optical
correction alone
14% achieved
6/12 or better
with optical
correction/oc
clusion
compared
with 0% with
optical
correction
alone
15. CONCLUSIONS
• Amblyopia improves with optical correction alone
in about one fourth of patients aged 7 to 17 years,
• For patients aged 7 to 12 years, prescribing 2 to 6
hours per day of patching with near visual
activities and atropine can improve visual acuity
even if the amblyopia has been previously treated.
• For patients 13 to 17 years, prescribing patching 2
to 6 hours per day with near visual activities may
improve visual acuity when amblyopia has not
been previously treated
17. PARTICIPANTS: 168 CHILDREN <7 years with amblyopia
in the range of 6/12 to 6/24 associated with
strabismus, anisometropia, or both
MAIN OUTCOME MEASURE: VA in the amblyopic eye
after 4 months.
RESULTS: The VA of the amblyopic eye at study
completion was either (1) at least 6/7.5 or (2) better
than or equal to that of the sound eye in 39 children
(47%) in the daily group and 45 children (53%) in the
weekend group
19. AMBLYOPIA TREATMENT STUDY ATS 5
OBJECTIVE To evaluate the effectiveness of refractive correction alone
for the treatment of untreated anisometropic amblyopia in children 3 to
<7 years old.
20. PARTICIPANTS: 84 children 3 to <7 years old with
untreated anisometropic amblyopia ranging from
6/12 to 6/75
METHODS: Optimal refractive correction was
provided, and visual acuity (VA) at baseline and at 5-
week intervals until VA stabilized or amblyopia
resolved
MAIN OUTCOME MEASURE: Maximum improvement
in BCVA in the amblyopic eye and proportion of
children whose amblyopia resolved (interocular
difference of < or =1 line) with refractive correction
alone.
21. RESULTS: Amblyopia improved with optical
correction by > or =2 lines in 77% and resolved in
27%. Improvement took up to 30 weeks for
stabilization criteria to be met
CONCLUSION: Refractive correction alone
improves VA in many cases and results in
resolution of amblyopia in at least one third of 3-
to <7-year-old children with untreated
anisometropic amblyopia
22. AMBLYOPIA TREATMENT STUDY ATS 5(2)
OBJECTIVE 2 hours of daily patching (combined with 1 hour of concurrent near
visual activities) VS control group of spectacle wear alone for treatment of
moderate to severe amblyopia in children 3 to 7 years old.
VS
23. PARTICIPANTS: 180 children 3 to 7 years old with BCVA amblyopic-eye
(VA) of 6/12 to 6/120 associated with strabismus, anisometropia, or
both who had worn optimal refractive correction for at least 16 weeks
or for 2 consecutive visits without improvement
INTERVENTION: Randomization either to 2 hours of daily patching with 1
hour of near visual activities or to spectacles alone
METHODS: visual acuity (VA) was measured at baseline and at 5-week
intervals until VA stabilized or amblyopia resolved
MAIN OUTCOME MEASURE: Best-corrected VA in the amblyopic eye
after 5 weeks
RESULTS: Improvement in VA of the amblyopic eye from baseline to 5
weeks averaged 1.1 lines in the patching group and 0.5 lines in the
spectacles alone
24. • CONCLUSION: After a period of treatment with spectacles, 2 hours
of daily patching combined with 1 hour of near visual activities
modestly improves moderate to severe amblyopia in children 3 to 7
years old.
>>
25. AMBLYOPIA TREATMENT STUDY ATS 6
OBJECTIVE To determine whether performing near activities while
patching for amblyopia enhances improvement in visual acuity.
?????????
26. PARTICIPANTS: 425 children,3 to <7 yrs, with amblyopia (6/12-6/120)
that was caused by anisometropia, strabismus, or both, and that
persisted after treatment with spectacles
METHODS: 2 hours of patching per day with near activities or 2 hours of
patching per day with distance activities. Study visits were scheduled at
2, 5, 8, and 17 weeks.
MAIN OUTCOME MEASURE: Masked assessment of VA at 8 weeks
RESULTS: At 8 weeks, improvement in amblyopic eye visual acuity
averaged 2.6 lines in the distance activities group and 2.5 lines in the
near activities group
CONCLUSION: Performing common near activities does not improve VA
when treating anisometropic, strabismic, or combined amblyopia with 2
hrs of daily patching.
Children with severe amblyopia may respond to 2 hours of daily
patching
27. AMBLYOPIA TREATMENT STUDY ATS 7
OBJECTIVE To determine the amount and time course of binocular
visual acuity improvement during treatment of bilateral refractive
amblyopia in 3 - <10 years of age
METHODS: 113 children with previously untreated bilateral
refractive amblyopia were provided with optimal spectacle
correction. Bilateral refractive amblyopia was defined as 6/12 to
6/120 best-corrected binocular visual acuity in the presence of 4.00 D
or more of hypermetropia , 2.00 D or more of astigmatism, or both
in each eye. Best-corrected binocular and monocular visual acuities
were measured at baseline and at five, 13, 26, and 52 weeks
28. MAIN OUTCOME MEASURE: The primary study
outcome was binocular acuity at one year
RESULTS: Binocular VA improved on average 3.9
lines, At 1 year, 74% had binocular VA of 6/7.5 or
better
CONCLUSION: Treatment of bilateral refractive
amblyopia with spectacle correction improves
binocular visual acuity in children three to less
than 10 years of age, with most improving to 6/7.5
or better within one year
29. AMBLYOPIA TREATMENT STUDY ATS 8
OBJECTIVE To compare weekend atropine sulfate use augmented
by a plano lens for the sound eye with weekend atropine use alone
for moderate amblyopia in children aged 3 years to younger than 7
years.
VS +
30. PARTICIPANTS: 180 children with moderate amblyopia
(visual acuities of 6/12-6/30) were randomized to weekend
atropine use augmented by a plano lens or weekend
atropine use alone.
MAIN OUTCOME MEASUREMasked assessment of
amblyopic eye visual acuity at 18 weeks.
RESULTS: Amblyopic eye VA was 6/7.5 or better in 29% of
the atropine only group and in 40% of the atropine plus
plano lens group(P <0.03)
CONCLUSION: : As an initial treatment for moderate
amblyopia, the augmentation of weekend atropine use
with a plano lens does not substantially improve
amblyopic eye visual acuity when compared with weekend
atropine use alone.
31. AMBLYOPIA TREATMENT STUDY ATS 9
OBJECTIVE patching with atropine eyedrops in the treatment of
moderate amblyopia (visual acuity, 6/12-6/30) in children aged 7 to 12
years.
vs
32. PARTICIPANTS: 193 children with amblyopia were assigned to receive
weekend atropine or patching of the sound eye 2 hours per day
MAIN OUTCOME MEASURE VA in the amblyopic eye at 17 weeks.
RESULTS: At 17 weeks, visual acuity had improved from baseline by an
average of 7.6 letters in the atropine group and 8.6 letters in the patching
group.
amblyopic va of 6/7.5 or better in 17% of atropine group and 24%
of patching group
CONCLUSION: : Treatment with atropine or patching led to similar
degrees of improvement among 7- to 12-year-olds with moderate
amblyopia.
33. AMBLYOPIA TREATMENT STUDY ATS 10
OBJECTIVE To determine whether visual acuity improvement with
Bangerter filters is similar to improvement with patching as initial
therapy for children with moderate amblyopia.
34. PARTICIPANTS:186 children, 3 to <10 years old, with moderate
amblyopia (6/12–6/24)
MAIN OUTCOME MEASURE Children were randomly assigned to
receive either daily patching or to use a Bangerter filter on the
spectacle lens in front of the fellow eye. Study visits were scheduled
at 6, 12, 18, and 24 weeks.Visual acuity in amblyopic eyes at 24 weeks.
RESULTS: Similar improvement in VA in both groups
• Amblyopic eye VA of 6/7.5 or better in 36% of Bangerter group and
31% of patching group (P=0.86)
CONCLUSION: : Because the average difference in VA improvement
between Bangerter filters and patching was less than half a line,
Bangerter filter treatment is a reasonable option to consider for initial
treatment of moderate amblyopia.
35. AMBLYOPIA TREATMENT STUDY ATS 11
OBJECTIVE Randomized trial to evaluate combined patching
and atropine for residual amblyopia IN 3 TO <10YR age group
PARTICIPANTS: 55 children,3-<10 with strabismic and/or
anisometropic amblyopia, best-corrected amblyopic eye acuity
of 20/32 to 20/63, interocular acuity difference greater than or
equal to 2 lines, and no improvement in amblyopic eye acuity
between 2 consecutive visits at least 6 weeks apart
36. • Before enrollment, eligible subjects had no improvement
with 6 hours daily patching or daily atropine
• Intensive treatment group had 6 hours of prescribed daily
patching combined with daily atropine; weaning group had
4 weeks of reduced treatment, then stopped
• Amblyopic eye VA improved similarly in both groups, an
average of 0.56 lines in the intensive group
• 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
Intensive final push of combined treatment with patching
and daily atropine did not produce a better visual acuity
outcome after 10 weeks
37. AMBLYOPIA TREATMENT STUDY 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
Nineteen children,with amblyopia (6/12-6/60) were randomly
assigned to receive either 2 hours of daily patching with
active vision therapy or 2 hours of daily patching with
placebo vision therapy.
The study was terminated due to difficulty in recruitment
under the proposed eligibility criteria
38. ATS 13
OBJECTIVE VA improvement in children with strabismic and combined
strabismic-anisometropic amblyopia treated with optical correction
alone
PARTICIPANTS:146 children 3 to <7 years old with previously
untreated strabismic amblyopia or combined-mechanismamblyopia
METHODS Optical treatment was provided as spectacles that were
worn for the first time at the baseline visit. VA measured at baseline
and every 9 weeks thereafter until no further improvement in visual
acuity. Ocular alignment was assessed at each visit.
MAIN OUTCOME MEASURE Visual acuity 18 weeks after baseline.
39. RESULTS: Mean 2.6 lines improvement
75% improved ≥2 lines and 54% improved ≥3 lines
Resolution in 32%
Treatment effect was greater for strabismic amblyopia than
for combined-mechanism amblyopia
CONCLUSION: :Consideration should be given to prescribing
refractive correction as the sole initial treatment for children with
strabismic or combined-mechanism amblyopia before initiating
other therapies.
40. ATS 14A 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 with STABLE
VA
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).
• 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.
41. • RESULTS
• 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
• 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
42. 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.
43. ON GOING TRAILS
• ATS 16: Augmenting atropine treatment for
amblyopia in 3 to <8, 20/50 to 20/400 with plano lens
to sound eye
• ATS 17A: Randomized trial of levodopa as treatment
for residual amblyopia
