Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Oculomotor Disorders: Experimental and Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Strabismus; Amblyopia
• Intervention / Treatment: Behavioral: Patching therapy, Glasses

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Kimberly Baynes, MSN; Phone Number: 216-444-2566; Email: baynesk@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Fatema Ghasia, MD; Phone Number: 216-318-7809
      • Contact: Kimberly Baynes; Phone Number: 2164442566; Email: baynesk@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children with diagnosis of strabismus and/or amblyopia

Description

Inclusion Criteria:

• History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria:

• History of neurologic disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.; Other Names: Strabismus surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Fatema Ghasia, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2020
• Primary Completion (ANTICIPATED): March 12, 2023
• Study Completion (ANTICIPATED): March 12, 2023

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (ACTUAL): March 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Ocular Motility Disorders; Vision Disorders; Strabismus; Amblyopia
• Other Study ID Numbers: 12-915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research publications require inclusion of de-identified data in the manuscript. We will also be presenting the data at local, national and international conferences.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: The de-identified research data will be shared with colleagues and will be published after peer-review.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No