Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Amblyopia Clinical Trial

Official title:

Oculomotor Disorders: Experimental and Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310241
• Other study ID #: 12-915
• Status: Recruiting
• Start date: February 21, 2020
• Est. completion date: March 12, 2025

Study information

• Verified date: June 2024
• Source: The Cleveland Clinic
• Contact: Kimberly Baynes, MSN
• Phone: 216-444-2566
• Email: baynesk[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 12, 2025
• Est. primary completion date: March 12, 2025
• Gender: All
• Age group: 6 Months to 90 Years

Eligibility

Inclusion Criteria:

• History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria:

• History of neurologic disorders

Related Conditions & MeSH terms

• Amblyopia
• Strabismus

Intervention

Behavioral:
• Patching therapy, Glasses
Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Functions	contrast sensitivity	0-3 years depending on duration of treatment
Primary	Visual Functions	visual acuity	0-3 years depending on duration of treatment
Primary	Visual functions	vernier acuity	0-3 years depending on duration of treatment
Primary	Visual functions	grating acuity	0-3 years depending on duration of treatment
Primary	Visual functions	binocular functions- stereopsis, inter-ocular functions	0-3 years depending on duration of treatment
Primary	Visual functions	eye movement measurements	0-3 years depending on duration of treatment
Primary	Visual functions	reading- reading speeds, eye movement measurements	0-3 years depending on duration of treatment