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