Phase 3
N=73
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT00944710 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Distribution of 10-week Amblyopic-Eye Visual Acuity — 0; 1; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atropine (Drug); Plano lens (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Oct 2013
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 |
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.
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.