A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Eligibility Criteria

• 1. Age 3 to \<13 years at the time of randomization
• 2. Amblyopia associated with anisometropia, strabismus, or both
• * 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.
• 1. Myopia greater than -6.00 D spherical equivalent in either eye.
• 2. Previous intraocular or refractive surgery.
• 3. Planned strabismus surgery in the next 56 weeks.
• 4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
• 5. Previous spectacle or contact lens wear for more than 24 hours.
• 6. Parent and participant willing to forego option of contact lens wear for the duration of the study.
• 7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).
• 8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.
• 9. Known allergy to adhesive patches.
• 10. Known allergy to silicone.