Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: The objectives of the Spectacle Phase are:

* In previously untreated pure anisometropic patients (i.e. patients who have not used spectacles in the last year and who do not have strabismus), to determine

  1. the incidence of resolution of amblyopia with spectacle correction alone and
  2. the time course of visual acuity improvement with spectacle correction alone.
* In all other patients, to achieve maximal improvement with spectacle correction prior to entering the randomized trial.

The objectives of the Randomized Trial are:

* To determine whether 5 weeks of patching treatment (2 hours of patching per day of the sound eye combined with at least one concurrent hour of near activities), compared with a control group (using spectacle correction only), improves visual acuity in patients with moderate to severe amblyopia (20/40 to 20/400).
* To determine the maximal improvement and time course of improvement with this patching treatment regimen.


Options:
A: Inclusion Criteria:

* Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
* Visual acuity in the amblyopic eye must be between 20/40 and 20/100
* Visual acuity in the sound eye or 20/40 or better
* At least 3 lines of acuity difference between the two eyes

Exclusion Criteria:

* More than two months of amblyopia therapy in the past two years
* Myopia (more than -0.50 D)
B: Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Prior amblyopia treatment other than spectacles in the past month.
* More than one month of amblyopia treatment in the past 6 months.
C: Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment
* No myopia in amblyopic eye
D: Inclusion Criteria:

* Age 3 to \<7 years
* Able to perform visual acuity using the ATS single-surround HOTV protocol
* Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both
* Visual acuity in the amblyopic eye 20/40 to 20/400 inclusive
* Visual acuity in the sound eye \>20/40
* Inter-eye acuity difference \>3 logMAR lines
* Cycloplegic refraction and ocular examination within 2 months prior to enrollment

Exclusion Criteria:

* No amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
* No current vision therapy or orthoptics
* No ocular cause for reduced visual acuity
* No myopia more than a spherical equivalent of -6.00 D
* No prior intraocular or refractive surgery
* No known skin reactions to patch or bandage adhesives

Answer: D