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

Primary Purpose

Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Patching
Prism Adaptation
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exotropia

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Los Angeles
  • Harvard University
  • Ross Eye Institute
  • University of Rochester Medical CenterRecruiting
  • University of Pittsburgh
  • Queen's University
  • LV Prasad Eye Institute
  • Shamir Medical Center
  • University of Milan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patching

Prism Adaptation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2022
Last Updated
October 18, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05242510
Brief Title
Evaluation of Exotropia After Patching the Eye or After Prism Adaptation
Acronym
DESDEE
Official Title
Divergence Excess/Simulated Divergence Excess Exotropia (DESDEE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exotropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patching
Arm Type
Experimental
Arm Title
Prism Adaptation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Patching
Intervention Description
The subject will occlude the non-dominant eye for 24 hours.
Intervention Type
Procedure
Intervention Name(s)
Prism Adaptation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of participants reclassified as divergence excess exotropia
Description
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.
Time Frame
2 weeks
Title
Percent of participants reclassified as simulated divergence excess exotropia
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew D Gearinger, MD
Phone
585 273-3937
Email
matthew_gearinger@urmc.rochester.edu
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Pineles
Email
pineles@jsei.ucla.edu
First Name & Middle Initial & Last Name & Degree
Federico Velez
Email
fgvucla@gmail.com
Facility Name
Harvard University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Dagi
Email
linda.dagi@childrens.harvard.edu
Facility Name
Ross Eye Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Arnoldi
Email
kylea@buffalo.edu
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Gearinger
Phone
585-275-8944
Email
matthew_gearinger@urmc.rochester.edu
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Philblad
Email
matthew.pihlblad2@chp.edu
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ning Strube
Email
yiningstrube@gmail.com
Facility Name
LV Prasad Eye Institute
City
Hyderabad
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesh Kekunnaya
Email
rameshak@lvpei.org
Facility Name
Shamir Medical Center
City
Rishon LeZion
State/Province
Central
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair Morad
Email
yair.morad@gmail.com
Facility Name
University of Milan
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Nucci
Email
paolo.nucci@unimi.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

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