Phase 3
N=240
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT00315302 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Visual Acuity Mean Score in the Amblyopic Eye — 0.23; 0.22; 0.54; 0.50 logMAR units — p=0.21
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 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity Mean Score in the Amblyopic Eye |
0.23; 0.22; 0.54; 0.50 | 0.21 |
| PRIMARY Visual Acuity Distribution in the Amblyopic Eye |
0; 0; 0; 1; 0; 0 | .03 sig |
| PRIMARY Mean Change in Visual Acuity in the Amblyopic Eye |
2.4; 2.8; 4.5; 5.1 | — |
| PRIMARY Distribution of Change in Visual Acuity in the Amblyopic Eye |
0; 1; 0; 0; 0; 0 | 0.39 |
| SECONDARY Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia |
3; 4; 40; 41; 7; 10 | 0.39 |
| SECONDARY Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only |
0; 0; 7; 9; 2; 3 | 0.90 |
| SECONDARY Mean Change in Visual Acuity in the Sound Eye |
0.4; 0.0; 0.10; 0.15 | — |
| SECONDARY Distribution of Change in Visual Acuity in the Sound Eye |
1; 1; 0; 0; 0; 1 | 0.003 sig |
| SECONDARY Visual Acuity Distribution in the Sound Eye |
1; 1; 0; 1; 0; 3 | — |
Summary
The purpose of the study is:
* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.
* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.
Eligibility Criteria
Inclusion Criteria
- Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Exclusion Criteria
- Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
- No myopia in amblyopic eye
Data sourced from ClinicalTrials.gov (NCT00315302). 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.