Clinical Trial: Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Clinical Trial of Observation Versus Controlled Intermittent Alternate Occlusion (CIAO) Therapy for Intermittent Exotropia

Brief Summary: To determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old.

Detailed Summary:

Intermittent exotropia (IXT) is the most common form of childhood-onset exotropia with an incidence of 32.1 per 100,000 in children. Before surgery, many cases of IXT are treated using non-surgical interventions, such as part-time alternate occlusion. However, the "alternating" occlusion with traditional patches is usually out of control. The investigators are uncertain about the amount of "alternating" in patching treatment.

Here, the investigators introduce controlled intermittent alternating occlusion (CIAO) therapy, which is provided by a new electronic device, -liquid crystal glasses. This study is to determine the effectiveness of alternate occlusion therapy for the treatment of IXT among patients aged 3 to < 11 years old. Children with IXT will be randomized into either an observation group or a CIAO therapy group.

Sponsor: Indiana University School of Medicine

Current Primary Outcome: Change in Composite measure of IXT control score and IXT deviation [ Time Frame: 12 weeks; 24 weeks ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: April 14, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: March 7, 2016
Last Verified: March 2016