CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 419 enrolled
Drug / intervention
Atropine +1 moredrug
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/NCT00000170
NCT00000170Phase 3Completed

Amblyopia Treatment Study: Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia

Jaeb Center for Health Research·interventional·Posted Sep 24, 1999·Updated Mar 6, 2014

In Brief

A Phase 3 clinical trial evaluating Atropine and Eye Patch for Amblyopia. Completed, enrolled 419 participants across 1 site.

Detailed Summary

* To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy * To develop more precise estimates of the success rates of amblyopia treatment * To identify factors that may be associated with successful treatment of amblyopia * To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients * Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. * Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmblyopia
CountriesUnited States

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartApr 1, 1999
Primary CompletionNov 1, 2001
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 26.8 years ago

Interventions

Atropinedrug

Atropine

Eye Patchdevice

Patching