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OpenTrials
Active, Not Recruiting

NCT Number: NCT06739798

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LRBT primary eyecare centre 18 Hazari

Jhang, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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."

  2. Visual Acuity

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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