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

Exclusion Criteria:

- • Amblyopic eye has myopia worse than -3.00D spherical equivalent.

- Previous amblyopia treatment within 6 months.

- Prior intraocular or refractive surgery

- Known skin reactions to patch or bandage adhesives

- Systemic diseases that may cause reduced vision such as Down syndrome.