N/A
Completed N=146
Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old
Source: ClinicalTrials.gov NCT00669539 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
May 2012
Primary outcomePrimary: Mean Amblyopic Eye Visual Acuity Improvement With Spectacles — 2.3; 3.2 logMAR units
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 visual acuity of 20/40 to 20/400
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Amblyopic Eye Visual Acuity Improvement With Spectacles |
2.3; 3.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 3 to =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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00669539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.