Evaluation of Exotropia After Patching the Eye or After Prism Adaptation (DESDEE)

February 9, 2024 updated by: Matthew Gearinger, University of Rochester

Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada
  • India
      • Hyderabad, India
        • Not yet recruiting
        • LV Prasad Eye Institute
        • Contact:
  • Israel
    • Central
      • Rishon LeZion, Central, Israel
  • Italy
      • Milan, Italy
  • United States
    • California
      • Los Angeles, California, United States, 90095
    • Massachusetts
    • New York
      • Buffalo, New York, United States, 14209
        • Not yet recruiting
        • Ross Eye Institute
        • Contact:
      • Rochester, New York, United States, 14642
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patching
Procedure: Patching
The subject will occlude the non-dominant eye for 24 hours.
Experimental: Prism Adaptation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of participants reclassified as divergence excess exotropia
Time Frame: 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.
2 weeks
Percent of participants reclassified as simulated divergence excess exotropia
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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