A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to <13 Years Old
Jaeb Center for Health Research
Summary
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.
Description
At an enrollment visit, distance VA will be measured in trial frames with or without cycloplegia based on a cycloplegic refraction performed within 30 days. If still apparently eligible, children will be prescribed spectacles and will then return for a spectacle baseline visit, where they will wear their new spectacles for the first time for at least 10 minutes (but no more than 24 hours) and will be tested in those new spectacles to confirm final eligibility prior to randomization. Participants not found to be eligible in their new spectacles will end study participation. Participants eligib…
Eligibility
- Age range
- 3–13 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 3 to \<13 years at the time of randomization 2. Amblyopia associated with anisometropia, strabismus, or both o Criteria for strabismic amblyopia: At least one of the following must be met: * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction) * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia) * Criteria for anisometropia: At least one of the following criteria must be met: * 1.00 D difference between eyes…
Interventions
- OtherPatching
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
- OtherGlasses
Eye Glasses are created and worn by patient to improve vision
Locations (68)
- UAB Pediatric Eye Care; Birmingham Health CareBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Midwestern University Eye InstituteGlendale, Arizona
- Arizonia Pediatric Eye SpecialistsPhoenix, Arizona
- University of ArizonaTucson, Arizona
- Univ. of California- BerkeleyBerkeley, California