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Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

NCT05242510 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-04-04

No results posted yet for this study

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

Interventions

PROCEDURE

Patching

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

PROCEDURE

Prism Adaptation

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2024-09-18
Completion
2024-09-18

Countries

  • United States
  • Canada
  • India
  • Israel
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05242510 on ClinicalTrials.gov