CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 386 enrolled
Drug / intervention
Overminus treatment +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/NCT02807350
NCT02807350N/ACompleted
CompareCT.gov

A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Jaeb Center for Health Research·interventional·Posted Jun 21, 2016·Updated Jun 3, 2022

In Brief

A clinical study evaluating Overminus treatment and Non-overminus treatment for Intermittent Exotropia. Completed, enrolled 386 participants across 61 sites in 2 countries.

Detailed Summary

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: * The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score. * The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntermittent Exotropia
CountriesCanada, United States
CollaboratorsPediatric Eye Disease Investigator Group, National Eye Institute (NEI)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 21, 2016
Enrollment StartJan 16, 2017
Primary CompletionNov 30, 2020
Study CompletionFeb 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.0 years ago

Interventions

Overminus treatmentdevice

spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere

Non-overminus treatmentdevice

spectacles with full cycloplegic refraction without overminus