A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

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 in spherical equivalent (SE)
• •* 1.50 D difference in astigmatism between corresponding meridians in the two eyes
• •* Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
• •* Criteria for strabismus are met (see above)
• •* 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
• •3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
• •4. Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:
• •1. Full correction of anisometropia
• •2. Full correction of astigmatism with the same axis found by the cycloplegic refraction
• •3. Full correction of any myopia
• •4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
• •5. At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:
• •* VA in the amblyopic eye 20/40 to 20/200 inclusive.
• •* Age-normal VA in the fellow eye:40,41
• •* 3 years: 0.4 logMAR (20/50) or better
• •* 4 years: 0.3 logMAR (20/40) or better
• •* 5-6 years: 0.2 logMAR (20/32) or better
• •* 7-12 years: 0.12 logMAR (78 letters) or better
• •* Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).
• •6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
• •7. Parent understands the protocol and is willing to accept randomization.
• •8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
• •9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.