Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

Exotropia Clinical Trial

— DESDEE  

Official title:

Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242510
• Other study ID #: STUDY00006849
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2024
• Source: University of Rochester
• Contact: Matthew D Gearinger, MD
• Phone: 585 273-3937
• Email: matthew_gearinger[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Exotropia

Intervention

Procedure:
• Patching
The subject will occlude the non-dominant eye for 24 hours.
• 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.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario
India	LV Prasad Eye Institute	Hyderabad
Israel	Shamir Medical Center	Rishon LeZion	Central
Italy	University of Milan	Milan
United States	Harvard University	Boston	Massachusetts
United States	Ross Eye Institute	Buffalo	New York
United States	University of California Los Angeles	Los Angeles	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Countries where clinical trial is conducted

United States,  Canada,  India,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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