Trial Outcomes & Findings for Combined Patching-Atropine for Residual Amblyopia (NCT NCT00506675)
NCT ID: NCT00506675
Last Updated: 2016-07-13
Results Overview
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
55 participants
Primary outcome timeframe
10 Weeks
Results posted on
2016-07-13
Participant Flow
Between October 2007 and March 2009, 27 subjects were randomized to the intensive group and 28 randomized to the weaning group.
Eligible subjects were aged 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.
Participant milestones
| Measure |
Intensive
6 hours daily patching combined with daily atropine
|
Weaning
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Patching-Atropine for Residual Amblyopia
Baseline characteristics by cohort
| Measure |
Intensive
n=27 Participants
6 hours daily patching combined with daily atropine
|
Weaning
n=28 Participants
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.9 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
6.9 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Age, Customized
3 to < 7 years
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
7 to < 10 years
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Cause of Amblyopia
Strabismus
|
10 participants
n=5 Participants
|
16 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Cause of Amblyopia
Anisometropia
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Cause of Amblyopia
Strabismus and Anisometropia
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Current Treatment for Amblyopia at Enrollment
Patching
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Current Treatment for Amblyopia at Enrollment
Atropine
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/63 (0.54 to 0.46 logMAR)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/50 (0.44 to 0.36 logMAR)
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/40 (0.34 to 0.26 logMAR)
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Distance Visual Acuity in Amblyopic Eye
20/32 (0.24 to 0.16 logMAR)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/32 (0.24 to 0.16 logMAR)
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/25 (0.14 to 0.06 logMAR)
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/20 (0.04 to -0.04 logMAR)
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Distance Visual Acuity in Fellow Eye
20/16 (-0.06 to -0.14 logMAR)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
< 0.00D
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
0 to < +1.00 D
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+1.00 to < +2.00D
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+2.00 to < +3.00D
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
+3.00 to < +4.00D
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Refractive Error in Amblyopic Eye (spherical equivalent/diopters)
greater than or equal to +4.00D
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
< 0.00D
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
0 to < +1.00D
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
+1.00 to < +2.00D
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
+2.00 to < +3.00D
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
+3.00 to < +4.00D
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Refractive Error in Fellow Eye
greater than or equal to +4.00D
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Mean (SD) Intereye Acuity Difference
|
0.33 logMAR
STANDARD_DEVIATION 0.11 • n=5 Participants
|
0.31 logMAR
STANDARD_DEVIATION 0.10 • n=7 Participants
|
0.32 logMAR
STANDARD_DEVIATION 0.11 • n=5 Participants
|
|
Mean (SD) Distance Visual Acuity in Fellow Eye
|
0.02 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.03 logMAR
STANDARD_DEVIATION 0.10 • n=7 Participants
|
0.03 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Mean (SD) Spherical Equivalent Refractive Error in Amblyopic Eye
|
5.39 diopters
STANDARD_DEVIATION 2.33 • n=5 Participants
|
4.24 diopters
STANDARD_DEVIATION 2.15 • n=7 Participants
|
4.81 diopters
STANDARD_DEVIATION 2.29 • n=5 Participants
|
|
Mean (SD) Spherical Equivalent Refractive Error in Fellow Eye
|
3.46 diopters
STANDARD_DEVIATION 2.38 • n=5 Participants
|
3.29 diopters
STANDARD_DEVIATION 1.90 • n=7 Participants
|
3.37 diopters
STANDARD_DEVIATION 2.13 • n=5 Participants
|
|
Mean (SD) Distance Visual Acuity in Amblyopic Eye
|
0.35 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.34 logMAR
STANDARD_DEVIATION 0.08 • n=7 Participants
|
0.35 logMAR
STANDARD_DEVIATION 0.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 WeeksVisual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Outcome measures
| Measure |
Intensive
n=27 Participants
6 hours daily patching combined with daily atropine
|
Weaning
n=28 Participants
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/125 (0.84 to 0.76 logMAR)
|
0 participants
|
1 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/100 (0.74 to 0.66 logMAR)
|
0 participants
|
0 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/80 (0.64 to 0.56 logMAR)
|
1 participants
|
1 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/63 (0.54 to 0.46 logMAR)
|
1 participants
|
4 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/50 (0.44 to 0.36 logMAR)
|
4 participants
|
0 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/40 (0.34 to 0.26 logMAR)
|
13 participants
|
9 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/32 (0.24 to 0.16 logMAR)
|
7 participants
|
7 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/25 (0.14 to 0.06 logMAR)
|
1 participants
|
3 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/20 (0.04 to -0.04 logMAR)
|
0 participants
|
2 participants
|
|
Distribution of Amblyopic Eye Visual Acuity at 10 Weeks
20/16 (-0.16 to -0.24 logMAR)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 10 WeeksVisual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equivalents for analyses (lower logMAR value is better than higher logMAR).
Outcome measures
| Measure |
Intensive
n=27 Participants
6 hours daily patching combined with daily atropine
|
Weaning
n=28 Participants
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
Mean (SD) Distribution of Visual Acuity at 10 Weeks
|
0.30 logMAR
Standard Deviation 0.10
|
0.29 logMAR
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: baseline to 10 WeeksChange in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Outcome measures
| Measure |
Intensive
n=27 Participants
6 hours daily patching combined with daily atropine
|
Weaning
n=28 Participants
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
greater than or equal to 3 lines
|
0 Participants
|
1 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
2 to < 3 lines worse
|
1 Participants
|
0 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
1 to < 2 lines worse
|
2 Participants
|
4 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
Within 1 logMAR line
|
12 Participants
|
8 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
1 to < 2 lines better
|
9 Participants
|
8 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
2 to < 3 lines better
|
3 Participants
|
5 Participants
|
|
Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks
greater than or equal to 3 lines better
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: baseline to 10 WeeksChange in logMAR from baseline to 10 weeks was calculated, with positive difference indicating improvement. Note one logMAR line = 5 letters or one Snellen line equivalent.
Outcome measures
| Measure |
Intensive
n=27 Participants
6 hours daily patching combined with daily atropine
|
Weaning
n=28 Participants
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam
|
0.056 logMAR
Standard Deviation 0.096
|
0.053 logMAR
Standard Deviation 0.150
|
Adverse Events
Intensive
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Weaning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intensive
n=27 participants at risk
6 hours daily patching combined with daily atropine
|
Weaning
n=28 participants at risk
For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
|
|---|---|---|
|
General disorders
Light sensitivity
|
22.2%
6/27 • Number of events 6 • 10 weeks
|
0.00%
0/28 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place