Efficacy of Intermittent Occlusion Therapy Glasses for Amblyopia

Inclusion Criteria

• •1. Age 3 to \< 8 years
• •2. Amblyopia associated with strabismus, anisometropia, or both
• •3. Visual acuity, measured in each eye without cycloplegia within 7 days prior to enrollment using the ATS single-surround HOTV letter protocol as follows:
• •* Visual acuity in the amblyopic eye between 20/100 and 20/400 inclusive
• •* Visual acuity in the sound eye 20/32 or better
• •4. Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction within 6 months:
• •* Requirements for spectacle correction:
• •* For patients meeting criteria for only strabismus i. Hypermetropia if corrected must not be undercorrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes. Otherwise, spectacle correction is at investigator discretion.
• •* For patients meeting criteria for anisometropia or combined-mechanism i. Spherical equivalent must be within 0.50 D of fully correcting the anisometropia ii. Hypermetropia must not be undercorrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes iii. Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism iv. Cylinder axis in the spectacle lenses in both eyes must be within 6 degrees of the axis of the cycloplegic refraction
• •5. Wearing optimal spectacle correction for a minimum of 4 weeks at the time of enrollment.
• •6. Gestational age \> 34 weeks and birth weight \> 1500 grams
• •7. Parent willing to accept randomization
• •8. Parent willing to be contacted and has access to phone
• •9. Parent does not anticipate relocation outside area of active study site