A Phase 3 interventional study of Eye Patch and Near activities in Amblyopia, sponsored by Jaeb Center for Health Research. Completed at 2 sites in United States. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2010-03-24.
Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.
The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.
In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.
This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.
The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.
183 studies on the registry are indexed under Amblyopia; 43 are open to participants now.
This study's enrollment of 425 is above the median of 60 across 133 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 hours of daily patching combined with near visual activities while patching
Device: Eye Patch · Procedure: Near activities
2 hours of daily patching combined with distance visual activities while patching
Device: Eye Patch · Procedure: Distance activities
2 hours daily patching
Also known as: Coverlet, 3M Opticlude, Ortopad®
near visual activities while patching
distance visual activities while patching
Visual acuity
Time frame: 8 weeks
Visual acuity
Time frame: 17 weeks
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jaeb Center for Health Research