Comparison of Binocular Spectacle Prescription Versus Patching Therapy in Refractive Amblyopia Patients

Not Applicable

Active, not recruiting

• Conditions: Amblyopia

• Registration Number: NCT06739798
• Lead Sponsor: Superior University

Brief Summary

This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.

Detailed Description

There will be a comparison of two treatment methods i.e. Patching and Binocular Spectacle Prescription used to cure amblyopia patients. In binocular spectacle correction, we will slightly blur the good eye and fully correct the amblyopic eye so that binocular functions stimulate and improve after the treatment. Literature suggests that Patching improve monocular functions but there is no significant improvement in binocular functions.

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Anisometropic amblyopia
• Anisometropia > 1.00 D( difference between eyes in SE)
• Astigmatism >1.50 D
• VA in amblyopic eye 20/40 -20/200(6/12-6/60) or less than 20/200
• VA in the better eye or fellow eye 20/30 (6/9) or better

Exclusion Criteria

• Strabismic amblyopia
• Deprivation amblyopia
• Isoametropic amblyopia
• History of ocular trauma, IOL implant
• Media opacity
• Any ocular/retinal pathology
• Optic nerve pathology
• Ptosis
• Any gaze control abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Binocular single vision	12 Months	it will be measured by Worth 4 Dot test in which patient will see four lights ( two green, one red and one white light) with red and green glasses and both eyes will see at once.; stereopsis: it will be measured grossly by seeing the fly picture at the card and fine stereopsis will be measured by different pictures available on the card. it will be assessed by wearing polarising glasses during test and see the 3D pictures."
Visual Acuity	12 months	it will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.

Trial Locations

Locations (1)

LRBT primary eyecare centre 18 Hazari; 🇵🇰 Jhang, Punjab, Pakistan