NCT05462821

Full-Time Occlusion Therapy for Intermittent Exotropia in Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Detailed 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).

Conditions

• Intermittent Exotropia

Interventions

Type	Name	Description
DEVICE	Eye Patch	adhesive patch to cover eye

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-07-18
• Last updated: 2025-12-02
• Results posted: 2025-12-02

Locations

25 sites across 1 country: United States