Evaluation of Exotropia After Patching the Eye or After P... | NCT05242510

Studies
Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

NCT05242510

Sponsor

University of Rochester

Status

Terminated

Last Update Posted

Apr 4, 2025Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Exotropia

Interventions

Patching
Prism Adaptation

Countries

United States
Canada
India
Israel
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of ability to enroll from other sites

Expanded Access Info

Start Date

Aug 27, 2024Actual

Primary Completion Date

Sep 18, 2024Actual

Completion Date

Sep 18, 2024Actual

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Feb 4, 2022

First Posted Date

Feb 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2025

Last Update Posted Date

Apr 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patching	Experimental		Procedure: Patching
Prism Adaptation	Experimental		Procedure: Prism Adaptation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patching	Procedure	The subject will occlude the non-dominant eye for 24 hours.	Patching

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of California Los Angeles		Los Angeles	California	90095	United States
Harvard University

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005099	Exotropia

Ancestor Terms

ID	Term
D013285	Strabismus
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided