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

December 13, 2024 updated by: Muhammad Naveed Babur, Superior University
This study will examine on Refractive Amblyopia patients, whose amblyopia started due to longstanding uncorrected refractive errors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Jhang, Punjab, Pakistan
        • LRBT primary eyecare centre 18 Hazari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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.
Experimental: Exp Group
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular single vision
Time Frame: 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."
12 Months
Visual Acuity
Time Frame: 12 months
it will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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