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Recruiting NCT04310241

Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Observational Amblyopia Strabismus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patching therapy, Glasses.
Who it may be relevant to
Registry conditions: Amblyopia, Strabismus. Basic parameters: 6 months — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Oculomotor Disorders: Experimental and Clinical Study

Overview

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.

Interventions

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

Primary outcome measures

  • Visual Functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual Functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual functions [Time frame: 0-3 years depending on duration of treatment]
  • Visual functions [Time frame: 0-3 years depending on duration of treatment]

Eligibility criteria

Inclusion criteria

  • History of amblyopia or presence of amblyogenic risk factors.

Exclusion criteria

  • History of neurologic disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

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. PMID 16213398
  • 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
  • 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

Identifiers

NCT: NCT04310241 · 12-915

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗