Clinical trial NCT04310241: Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy
Official title: Oculomotor Disorders: Experimental and Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amblyopia
Strabismus
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with diagnosis of strabismus and/or amblyopia

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.

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.

Eligibility criteria: Inclusion Criteria:

* History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria:

* History of neurologic disorders

Primary outcomes:
measure: Visual Functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual Functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual functions
timeFrame: 0-3 years depending on duration of treatment
measure: Visual functions
timeFrame: 0-3 years depending on duration of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Fatema Ghasia, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.