Phase 3
N=169
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT00945100 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Distribution of 10-week Amblyopic Eye Visual Acuity — 1; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Eye Patch (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of 10-week Amblyopic Eye Visual Acuity |
1; 0; 0; 0; 3; 3 | — |
| PRIMARY Mean 10-week Amblyopic Eye Visual Acuity |
0.38; 0.33 | 0.002 sig |
| PRIMARY Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization |
1; 0; 3; 2; 13; 7 | — |
| PRIMARY Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization |
0.5; 1.2 | — |
| SECONDARY Compliance With Prescribed Patching by Treatment Group at 10 Weeks |
66; 59; 10; 14; 0; 5 | — |
| SECONDARY Average Compliance With Prescribed Patching by Treatment Group |
65; 60; 11; 15; 1; 4 | — |
| SECONDARY Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization |
15; 33 | 0.003 sig |
| SECONDARY Treatment Group Comparison of 10-week Interocular Difference |
3.7; 3.2 | 0.01 sig |
| SECONDARY Distribution of Baseline Characteristics at the 10-week Outcome |
43; 41; 39; 41; 56; 63 | — |
| SECONDARY Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome |
0.44; 0.45; 0.41; 0.44; 0.42; 0.45 | — |
| SECONDARY Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics |
0.4; 1.4; 0.7; 0.9; 0.5; 1.2 | 0.04 sig |
| SECONDARY Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity |
1; 0; 0; 0; 2; 2 | — |
| SECONDARY Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity |
0.33; 0.30 | — |
| SECONDARY Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye |
1; 0; 3; 2; 12; 6 | — |
| SECONDARY Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity |
0.9; 1.5 | — |
| SECONDARY Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit |
32; 42 | — |
| SECONDARY Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Mean Best Fellow Eye Visual Acuity at 10-week Outcome |
0.00; 0.00 | — |
| SECONDARY Distribution of Best Fellow Eye Visual Acuity at Final Visit |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Mean Best Fellow Eye Visual Acuity at Final Visit |
-0.01; 0.00 | — |
| SECONDARY Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks |
1; 1; 0; 0; 14; 16 | >0.99 |
| SECONDARY Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks |
-0.10; -0.02 | — |
| SECONDARY Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit |
2; 0; 1; 0; 11; 16 | 0.12 |
| SECONDARY Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit |
-0.04; 0.02 | — |
| SECONDARY Distribution of Randot Preschool Stereoacuity Scores at Randomization |
10; 7; 39; 47; 10; 8 | — |
| SECONDARY Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks |
8; 7; 33; 44; 13; 10 | — |
| SECONDARY Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization |
2; 2; 62; 59; 5; 7 | 0.28 |
| SECONDARY Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia |
3; 3; 15; 17; 7; 3 | — |
| SECONDARY Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia |
3; 2; 11; 17; 7; 4 | — |
| SECONDARY Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia |
0; 2; 32; 22; 3; 4 | 0.45 |
Summary
This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. 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 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Eligibility Criteria
Inclusion Criteria
Major Eligibility Criteria for Run-in Phase
- Age 3 to 3 logMAR lines
- Amblyopia treatment within the past 6 months subject to the following stipulations:
- No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
- No simultaneous treatment with patching and atropine
- No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
- Maximum level of treatment within the past 6 months:
- Patching: up to 2 hours daily
- Atropine: up to once daily
- Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.
Eligibility Criteria for Randomization:
- Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
- Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.
Exclusion Criteria
- Currently using vision therapy or orthoptics
- Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
- Prior intraocular or refractive surgery
- Known skin reaction to patch or bandage adhesives
Data sourced from ClinicalTrials.gov (NCT00945100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.