NCT02223650

A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Intermittent Exotropia

Interventions

Type	Name	Description
DEVICE	Overminus treatment	2.50D overminus spectacles
DEVICE	Non-overminus treatment	spectacles without overminus or no spectacles

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-08-22
• Last updated: 2017-05-19
• Results posted: 2016-12-20

Locations

2 sites across 1 country: United States