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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06739798
Enrollment
32
Registered
2024-12-18
Start date
2024-04-01
Completion date
2025-03-30
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

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.

Interventions

DIAGNOSTIC_TESTExp 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.

DIAGNOSTIC_TESTControl 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.

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Binocular single vision12 Monthsit 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 Acuity12 monthsit will be assessed monocularly by logMAR visual acuity chart at 4 meter distance.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026