Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Recruiting

• Conditions: Amblyopia; Strabismus
• Interventions: Behavioral: Patching therapy, Glasses

• Registration Number: NCT04310241
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2020-02-21
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-03-12
• Study Completion: 2025-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria

• History of neurologic disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amblyopia	Patching therapy, Glasses	Clinical diagnosis of amblyopia

Primary Outcome Measures

Name	Time	Method
Visual functions	0-3 years depending on duration of treatment	reading- reading speeds, eye movement measurements
Visual Functions	0-3 years depending on duration of treatment	visual acuity

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States