Status:
COMPLETED
Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-6 years
Brief Summary
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 visua...
Detailed Description
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 visua...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00669539
Start Date
May 1 2008
End Date
December 1 2010
Last Update
July 13 2016
Active Locations (1)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831-1699