Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

NCT ID: NCT04310241

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2027-03-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amblyopia Strabismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control subjects

Subjects who state they have no eye or neurologic problems or disease other than perhaps wearing glasses or contact lenses and upon review of medical history.

No interventions assigned to this group

Amblyopia

Clinical diagnosis of amblyopia

Patching therapy, Glasses

Intervention Type BEHAVIORAL

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

Interventions

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Patching therapy, Glasses

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Strabismus surgery

Eligibility Criteria

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Inclusion Criteria

* History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria

* History of neurologic disorders
Minimum Eligible Age

6 Months

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Fatema Ghasia

Associate Staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatema Ghasia, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kimberly Baynes, MSN

Role: CONTACT

216-444-2566

Facility Contacts

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Fatema Ghasia, MD

Role: primary

216 318 7809

Kimberly Baynes

Role: backup

2164442566

References

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Shaikh AG, Otero-Millan J, Kumar P, Ghasia FF. Abnormal Fixational Eye Movements in Amblyopia. PLoS One. 2016 Mar 1;11(3):e0149953. doi: 10.1371/journal.pone.0149953. eCollection 2016.

Reference Type BACKGROUND
PMID: 26930079 (View on PubMed)

Ghasia FF, Otero-Millan J, Shaikh AG. Abnormal fixational eye movements in strabismus. Br J Ophthalmol. 2018 Feb;102(2):253-259. doi: 10.1136/bjophthalmol-2017-310346. Epub 2017 Jul 11.

Reference Type BACKGROUND
PMID: 28698242 (View on PubMed)

Chatzistefanou KI, Theodossiadis GP, Damanakis AG, Ladas ID, Moschos MN, Chimonidou E. Contrast sensitivity in amblyopia: the fellow eye of untreated and successfully treated amblyopes. J AAPOS. 2005 Oct;9(5):468-74. doi: 10.1016/j.jaapos.2005.05.002.

Reference Type BACKGROUND
PMID: 16213398 (View on PubMed)

Other Identifiers

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12-915

Identifier Type: -

Identifier Source: org_study_id

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