Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

NCT04310241 | Recruiting

• 1 other identifier: 12-915
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amblyopia; Strabismus

Outcome Measures

Primary Outcomes (7)

• Visual Functions

  contrast sensitivity

  0-3 years depending on duration of treatment

• Visual Functions

  visual acuity

  0-3 years depending on duration of treatment

• Visual functions

  vernier acuity

  0-3 years depending on duration of treatment

• Visual functions

  grating acuity

  0-3 years depending on duration of treatment

• Visual functions

  binocular functions- stereopsis, inter-ocular functions

  0-3 years depending on duration of treatment

• Visual functions

  eye movement measurements

  0-3 years depending on duration of treatment

• Visual functions

  reading- reading speeds, eye movement measurements

  0-3 years depending on duration of treatment

Study Arms (2)

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.

Amblyopia

Clinical diagnosis of amblyopia

Behavioral: Patching therapy, Glasses

Interventions

Patching therapy, Glasses BEHAVIORAL

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

Also known as: Strabismus surgery

Amblyopia

Eligibility Criteria

• Age: 6 Months - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

children with diagnosis of strabismus and/or amblyopia

You may qualify if:

• History of amblyopia or presence of amblyogenic risk factors.

You may not qualify if:

• History of neurologic disorders

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 16213398 BACKGROUND

• 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.

  PMID: 26930079 RESULT

• 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.

  PMID: 28698242 RESULT

MeSH Terms

Conditions

Amblyopia; Strabismus

Interventions

Eyeglasses

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; Ocular Motility Disorders; Cranial Nerve Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Fatema Ghasia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Baynes, MSN

CONTACT

216-444-2566; baynesk@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 17, 2020
• Study Start: February 21, 2020
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: The de-identified research data will be shared with colleagues and will be published after peer-review.

Locations

US (1)