CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 169 enrolled
Drug / intervention
Eye Patch +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00945100
NCT00945100Phase 3Completed
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Increasing Patching for Amblyopia in Children 3 to < 8 Years Old

Jaeb Center for Health Research·interventional·Posted Jul 23, 2009·Updated Jul 13, 2016

In Brief

A Phase 3 clinical trial evaluating Eye Patch for Amblyopia. Completed, enrolled 169 participants across 2 sites.

Detailed Summary

This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and 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 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week). The primary objective is to determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmblyopia
CountriesUnited States
CollaboratorsNational Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 23, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.9 years ago

Interventions

Eye Patchdevice

42 hours patching per week (averaging 6 hours patching daily)

Eye Patchdevice

2 hours patching daily