Phase 3
Completed N=73
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
Source: ClinicalTrials.gov NCT00944710 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Distribution of 10-week Amblyopic-Eye Visual Acuity — 0; 1; 2; 0 participants
Summary
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but 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 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. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of 10-week Amblyopic-Eye Visual Acuity |
0; 1; 2; 0; 1; 2 | — |
| PRIMARY Mean 10-week Amblyopic-Eye Visual Acuity |
0.42; 0.37 | 0.12 |
| PRIMARY Distribution of the Change in Amblyopic-Eye Visual Acuity |
0; 0; 1; 2; 4; 3 | — |
| PRIMARY Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization |
0.6; 1.1 | — |
| SECONDARY Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization |
4; 6 | — |
| 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 |
8; 9 | 0.33 |
| SECONDARY Spectacle Compliance at 10 Weeks by Treatment Group |
39; 30; 1; 1; 0; 1 | — |
| SECONDARY Average Spectacle Compliance by Treatment Group |
39; 30; 1; 2; 0; 0 | — |
| SECONDARY Atropine Compliance at 10 Weeks by Treatment Group |
38; 31; 2; 2; 0; 0 | — |
| SECONDARY Average Atropine Compliance by Treatment Group |
39; 29; 1; 4; 0; 0 | — |
| SECONDARY Distribution of Interocular Difference at 12-week Exam |
3; 2; 2; 2; 6; 8 | — |
| SECONDARY Mean Interocular Difference at 12-week Exam |
4.3; 3.3 | — |
| SECONDARY Distribution of 12-week Fellow-Eye Visual Acuity |
1; 0; 0; 4; 10; 7 | — |
| SECONDARY Mean Fellow-Eye Visual Acuity at 12-week Exam |
0.01; 0.02 | — |
| SECONDARY Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization |
1; 0; 0; 0; 1; 2 | — |
| SECONDARY Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization |
0.4; 0.3 | 0.55 |
| SECONDARY Distribution of Baseline Characteristics at the 10-week Outcome |
21; 19; 18; 14; 32; 29 | — |
| SECONDARY Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome |
0.51; 0.46; 0.45; 0.51; 0.50; 0.49 | — |
| SECONDARY Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics |
0.2; 1.2; 1.0; 1.1; 0.5; 1.1 | — |
| SECONDARY Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit |
0; 1; 2; 0; 1; 0 | — |
| SECONDARY Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit |
0.40; 0.29 | — |
| SECONDARY Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit |
0; 0; 1; 1; 4; 3 | — |
| SECONDARY Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit |
0.8; 1.9 | — |
| 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 Outcome Visit |
11; 20 | — |
| SECONDARY Distribution of Randot Preschool Stereoacuity Score at 12 Weeks |
4; 2; 7; 10; 14; 12 | 0.23 |
| SECONDARY Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia |
0; 0; 1; 1; 2; 2 | 0.66 |
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 atropine 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 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 atropine can be initiated simultaneously).
- Hypermetropia and spectacle correction in sound eye of +1.50 D or more
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.
- Compliance with weekend atropine treatment based on investigator judgment.
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 allergy to atropine or other cycloplegic drugs
- Down Syndrome present
Data sourced from ClinicalTrials.gov (NCT00944710). 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. Informational only — not medical advice.