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

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: Terminated
• Conditions: Exotropia
• Intervention / Treatment: Procedure: Patching; Procedure: Prism Adaptation

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Queen's University
• India
  • Hyderabad, India
    • LV Prasad Eye Institute
• Israel
  • Central
    • Rishon LeZion, Central, Israel
      • Shamir Medical Center
• Italy
  • Milan, Italy
    • University of Milan
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard University
  • New York
    • Buffalo, New York, United States, 14209
      • Ross Eye Institute
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Actual): September 18, 2024
• Study Completion (Actual): September 18, 2024

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): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• 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
• product manufactured in and exported from the U.S.: No