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

NCT ID: NCT06739798

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Amblyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Exp Group

Group Type EXPERIMENTAL

Exp Group

Intervention Type DIAGNOSTIC_TEST

Binocular Spectacle prescription are therapeutic tools used to correct refractive errors in visually impaired patients. They improve Visual acuity as well as other visual functions in Amblyopic and visual impairment patients. They stimulate weaker eye to generate visual impulse and stimulate visual cortex to improve stereopsis and fusion.

Control Group

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type DIAGNOSTIC_TEST

Patching therapy is a gold standard tool used world wide to correct visual acuity in amblyopic patients. This tool is used by occluding stronger eye with a patch or bandage or fogging lens and stimulating amblyopic eye to generate visual stimulus to motivate visual cortex.

Interventions

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Exp Group

Binocular Spectacle prescription are therapeutic tools used to correct refractive errors in visually impaired patients. They improve Visual acuity as well as other visual functions in Amblyopic and visual impairment patients. They stimulate weaker eye to generate visual impulse and stimulate visual cortex to improve stereopsis and fusion.

Intervention Type DIAGNOSTIC_TEST

Control Group

Patching therapy is a gold standard tool used world wide to correct visual acuity in amblyopic patients. This tool is used by occluding stronger eye with a patch or bandage or fogging lens and stimulating amblyopic eye to generate visual stimulus to motivate visual cortex.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LRBT primary eyecare centre 18 Hazari

Jhang, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSRSW/Batch-Fall22/755

Identifier Type: -

Identifier Source: org_study_id