CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 611 enrolled
Drug / intervention
occlusion treatmentdevice
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/NCT01032330
NCT01032330N/ACompleted

A Randomized Clinical Trial of Observation Versus Occlusion Therapy for Intermittent Exotropia

Jaeb Center for Health Research·interventional·Posted Dec 15, 2009·Updated May 19, 2020

In Brief

A clinical study evaluating occlusion treatment for Exotropia. Completed, enrolled 611 participants across 2 sites.

Detailed Summary

The present study is being conducted to assess the natural history of intermittent exotropia and to establish the effectiveness of occlusion in its treatment. Study Objectives: * To determine the effectiveness of occlusion for the treatment of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest * To determine the natural history of intermittent exotropia among patients aged 3 to \< 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.5 years ago

Interventions

occlusion treatmentdevice

Patients randomized to the occlusion treatment group will receive occlusion (patching) for 3 hours per day for at least 3 months. Choice of which eye to occlude, or whether to alternate daily, is at investigator's discretion.