Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children
Completed · Phase 3
Conditions studied: Amblyopia
In brief
The objectives of the Spectacle Phase are: * In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine 1. the incidence of resolution of amblyopia with spectacle correction alone and 2. the time course of visual acuity improvement with spectacle correction alone. * In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial. The objectives of the Randomized Trial are: * To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400). * To determine the maximal improvement and time course of improvement with this patching treatment regimen.
Key facts
- Study ID
- NCT00091923
- Run by
- Jaeb Center for Health Research
- People needed
- 268
- Starts
- 2004-02-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2010-03-24
Who can join
Age: 3 and older, up to 7. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 3 to <7 years
- Able to perform visual acuity using the ATS single-surround HOTV protocol
- Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
- Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
- Visual acuity in the sound eye >20/40
- Inter-eye acuity difference >3 logMAR lines
- Cycloplegic refraction and ocular examination within 2 months prior to enrollment
You may not qualify if…
- No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
- No current vision therapy or orthoptics
- No ocular cause for reduced visual acuity
- No myopia more than a spherical equivalent of -6.00 D
- No prior intraocular or refractive surgery
- No known skin reactions to patch or bandage adhesives
Where it is running
- Southern California College of Optometry — Fullerton, California, United States
- Duke University Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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