Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

Not Applicable

Terminated

• Conditions: Exotropia
• Interventions: Procedure: Patching; Procedure: Prism Adaptation

• Registration Number: NCT05242510
• Lead Sponsor: University of Rochester

Brief Summary

This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-02-04
• Study First Posted: 2022-02-16
• Study Start: 2024-08-27
• Primary Completion: 2024-09-18
• Study Completion: 2024-09-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
• No prior strabismus surgery
• Able to cooperate with testing (by examiner determination)
• Neurologically normal except for strabismus (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
• Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better)
• Under 18 years of age. There is no lower age limit as long as the subject can cooperate for the required testing.
• No diagnosis of dissociated vertical deviation

Exclusion Criteria

• No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
• Prior strabismus surgery
• Unable to cooperate with testing (by examiner determination)
• Diagnosed with a neurological disorder (ADHD and autism spectrum are not exclusion criteria as long as the subject can cooperate for necessary testing)
• Best-corrected visual acuity in either eye worse than 20/40
• 18 years of age or older
• Diagnosed with dissociated vertical deviation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patching	Patching	-
Prism Adaptation	Prism Adaptation	-

Primary Outcome Measures

Name	Time	Method
Percent of participants reclassified as divergence excess exotropia	2 weeks	Percentage of patients with distance and near exotropia measurements within 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.
Percent of participants reclassified as simulated divergence excess exotropia	2 weeks	Percentage of patients with distance and near exotropia measurements differing by more than 2.5 prism diopters on alternate prism and cover testing after 24 hours of patching or 7-14 days of fresnel prism use.

Trial Locations

Locations (9)

Ross Eye Institute; 🇺🇸 Buffalo, New York, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Harvard University; 🇺🇸 Boston, Massachusetts, United States

Queen's University; 🇨🇦 Kingston, Ontario, Canada

LV Prasad Eye Institute; 🇮🇳 Hyderabad, India

Shamir Medical Center; 🇮🇱 Rishon LeZion, Central, Israel

University of Milan; 🇮🇹 Milan, Italy