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Clinical Trials/NCT04310241
NCT04310241
Recruiting
Not Applicable

Oculomotor Disorders: Experimental and Clinical Study

The Cleveland Clinic1 site in 1 country150 target enrollmentFebruary 21, 2020

Overview

Phase
Not Applicable
Intervention
Patching therapy, Glasses
Conditions
Amblyopia
Sponsor
The Cleveland Clinic
Enrollment
150
Locations
1
Primary Endpoint
Visual Functions
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.

Detailed Description

To examine the response of therapy on visual functions in amblyopic and strabismic participants. The following visual functions will be measured prior to treatment. Eye movements, contrast sensitivity, grating acuity, visual acuity, vernier acuity, binocular visual functions, reading and visual scanning will be measured. The testing will comprise of one or more of the above paradigms depending on participant's cooperation and understanding as majority of the study participants will be children. The above measurements will be repeated during amblyopia therapy ( which comprises of glasses, patching and/or atropine eye drops) and at the completion of treatment. For participants with strabismus requiring strabismus surgery the measurements will be repeated after strabismus surgery.

Registry
clinicaltrials.gov
Start Date
February 21, 2020
End Date
March 12, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatema Ghasia

Associate Staff

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria

  • History of neurologic disorders

Arms & Interventions

Amblyopia

Clinical diagnosis of amblyopia

Intervention: Patching therapy, Glasses

Control subjects

Subjects who state they have no eye or neurologic problems or disease other than perhaps wearing glasses or contact lenses and upon review of medical history.

Outcomes

Primary Outcomes

Visual Functions

Time Frame: 0-3 years depending on duration of treatment

contrast sensitivity

Visual functions

Time Frame: 0-3 years depending on duration of treatment

vernier acuity

Study Sites (1)

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