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NCT Number: NCT04310241

Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Ocular Motility Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Strabismus Vision Disorders

Age range

6 month–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

To examine the response of therapy on visual functions in amblyopic and strabismic participants.

The following visual functions will be measured prior to treatment. Eye movements, contrast sensitivity, grating acuity, visual acuity, vernier acuity, binocular visual functions, reading and visual scanning will be measured. The testing will comprise of one or more of the above paradigms depending on participant's cooperation and understanding as majority of the study participants will be children. The above measurements will be repeated during amblyopia therapy ( which comprises of glasses, patching and/or atropine eye drops) and at the completion of treatment. For participants with strabismus requiring strabismus surgery the measurements will be repeated after strabismus surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of amblyopia or presence of amblyogenic risk factors.

Exclusion criteria

  • History of neurologic disorders

Treatment and study plan

Patching therapy, Glasses

Behavioral

Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.

Other names: Strabismus surgery

Primary outcomes

  1. Visual Functions

    Time frame: 0-3 years depending on duration of treatment

    contrast sensitivity

  2. Visual Functions

    Time frame: 0-3 years depending on duration of treatment

    visual acuity

  3. Visual functions

    Time frame: 0-3 years depending on duration of treatment

    vernier acuity

  4. Visual functions

    Time frame: 0-3 years depending on duration of treatment

    grating acuity

  5. Visual functions

    Time frame: 0-3 years depending on duration of treatment

    binocular functions- stereopsis, inter-ocular functions

  6. Visual functions

    Time frame: 0-3 years depending on duration of treatment

    eye movement measurements

  7. Visual functions

    Time frame: 0-3 years depending on duration of treatment

    reading- reading speeds, eye movement measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Kimberly Baynes, MSN

CONTACT

[email protected]

216-444-2566

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Oculomotor Disorders: Experimental and Clinical Study

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2020
Registry last updated
Mar 4, 2026

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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