Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children

UCI Specialty Area: Eye Care

Principal Investigator: Donny Won Suh

Official Title: Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children

A Study On:

Eye - Ophthalmologic

Study Description

Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies.

The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Eligibility

Inclusion Criteria - Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:

Age 3 to < 9 years
IXT meeting all of the following criteria:

a. Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia)

b. Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments)

c. Distance exodeviation between 15∆ and 50∆ by PACT

d. Near exodeviation between 0∆ and 50∆ by PACT

e. Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded)

Age-normal visual acuity in both eyes:

a. 3 years: 20/50 or better (>=63 letters)

b. 4 years: 20/40 or better (>=68 letters)

c. 5-6 years: 20/32 or better (>=73 letters)

d. 7-<9 years: 20/25 or better (>=78 letters)

Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥7 years old.
Cycloplegic refraction within the last 7 months.
Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months

Other Protocol defined inclusion/ exclusion criteria may apply.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
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immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

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