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

NCT06739798 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/755
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amblyopia

Outcome Measures

Primary Outcomes (2)

• Binocular single vision

  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

  it will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.

  12 months

Study Arms (2)

Exp Group

EXPERIMENTAL

Diagnostic Test: Exp Group

Control Group

ACTIVE COMPARATOR

Diagnostic Test: Control Group

Interventions

Exp Group 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.

Exp Group

Control Group 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.

Control Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

LRBT primary eyecare centre 18 Hazari

Jhang, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)