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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia — IXT3  

Intermittent Exotropia Clinical Trial

Official title:
A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Clinical Trial Summary

The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.

Clinical Trial Description

The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to overminus by comparing treatment groups on the following outcomes:

- Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)

- The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)

- Adverse effects, near visual acuity outcomes, and spectacle wear compliance ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02223650
Study type Interventional
Source Jaeb Center for Health Research
Contact
Status Completed
Phase Phase 2/Phase 3
Start date December 2014
Completion date July 2015
View Details
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