Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children
Completed · Phase 3
Conditions studied: Amblyopia
In brief
This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to \< 10 years. Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity. The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes. The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model. Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.
Key facts
- Study ID
- NCT00525174
- Run by
- Jaeb Center for Health Research
- People needed
- 186
- Starts
- 2007-11-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2016-07-13
Who can join
Age: 3 and older, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 3 to < 10 years
- Amblyopia associated with strabismus, anisometropia, or both
- No ocular cause apparent for reduced visual acuity
- Visual acuity 20/40 to 20/80 (71 to 54 letters inclusive) in amblyopic eye
- Visual acuity 20/40 or better (>= 69 letters) in sound eye
- Interocular difference >= 3 logMAR lines (>= 15 letters)
- No amblyopia treatment other than spectacles in last 6 months
- Any treatment more than 6 months prior to enrollment is acceptable
- Currently wearing spectacles
- Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual acuity documented to be stable
- No myopia > -6.00 D spherical equivalent in either eye
- Cycloplegic refraction within 6 months prior to enrollment
- Ocular examination within 6 months prior to enrollment
You may not qualify if…
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- Known skin reactions to patch or bandage adhesives
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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