Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old

Completed

Conditions studied: Amblyopia

In brief

This study will evaluate the effectiveness of refractive correction alone for the treatment of previously untreated strabismic or combined-mechanism amblyopia in children 3 to \<7 years old with visual acuity of 20/40 to 20/400

Key facts

Study ID

NCT00669539

Run by

Jaeb Center for Health Research

People needed

156

Starts

2008-05-01

Expected to finish

2010-12-01

Last updated by the study team

2016-07-13

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 3 to <7 years old
• Able to perform visual acuity testing using the ATS single-surround HOTV protocol
• Amblyopia associated with strabismus (comitant or incomitant) with or without anisometropia
• At least one of the following criteria must be met:
• Heterotropia at distance and/or near fixation on examination (without spectacles)
• History of strabismus surgery (or botulinum toxin extraocular muscle injection)
• Documented history of strabismus that is no longer present (and which in the judgment of the investigator is the cause of amblyopia)
• Visual acuity measured in each eye according to the protocol procedures that meet the following criteria:
• Amblyopic eye 20/40 to 20/400 inclusive
• Sound eye >=20/40
• Inter-eye acuity difference >= 3 logMAR lines (i.e., amblyopic eye acuity at least 3 logMAR lines worse than sound eye acuity)
• No previous spectacle correction
• Refractive error meeting at least 1 of the following criteria: >= 1.00D of astigmatism in the amblyopic eye, >= 1.00D spherical equivalent anisometropia, or >= +2.00D spherical equivalent hyperopia in either eye.
• Investigator wishes to prescribe spectacles to correct refractive error
• Nystagmus per se does not exclude the patient if the above visual acuity criteria are met
• Ocular examination within 2 months prior to enrollment
• Cycloplegic refraction within 2 months prior to enrollment
• No myopia = -0.25D spherical equivalent)
• Parent understands protocol and is willing to accept treatment
• Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff
• Relocation outside of area of an active ATS site within next 6 months not anticipated

You may not qualify if…

• Prior amblyopia treatment
• Current vision therapy or orthoptics
• Ocular cause for reduced visual acuity
• Prior intraocular or refractive surgery
• Strabismus surgery planned in the 9 weeks following the Baseline Visit

Where it is running

• Southern California College of Optometry — Fullerton, California, United States

Full record on ClinicalTrials.gov

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