Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

NCT05242510 | Terminated

• 1 other identifier: STUDY00006849
• Study Type: interventional
• Target: 1
• Locations: 5 countries
• Sites: 9

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.

Conditions

Exotropia

Outcome Measures

Primary Outcomes (2)

• Percent of participants reclassified as divergence excess exotropia

  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.

  2 weeks

• Percent of participants reclassified as simulated divergence excess exotropia

  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.

  2 weeks

Study Arms (2)

Patching

EXPERIMENTAL

Procedure: Patching

Prism Adaptation

EXPERIMENTAL

Procedure: Prism Adaptation

Interventions

Patching PROCEDURE

The subject will occlude the non-dominant eye for 24 hours.

Patching

Prism Adaptation PROCEDURE

The subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion.

Prism Adaptation

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)
• Best-corrected visual acuity in either eye worse than 20/40
• years of age or older
• Diagnosed with dissociated vertical deviation

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (9)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Harvard University

Boston, Massachusetts, 02115, United States

Location

Ross Eye Institute

Buffalo, New York, 14209, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Queen's University

Kingston, Ontario, Canada

Location

LV Prasad Eye Institute

Hyderabad, India

Location

Shamir Medical Center

Rishon LeZiyyon, Central District, Israel

Location

University of Milan

Milan, Italy

Location

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 16, 2022
• Study Start: August 27, 2024
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); IL (1); IN (1); CA (1); IT (1)