Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Occlusion Treatment of Amblyopia Study (ROTAS): Trial of Maximal Vs Substantial Doses of Occlusion to Evaluate Visual Outcome for Children With Amblyopia
Brief Summary: Amblyopia ('lazy eye') is the commonest visual disorder of childhood and is caused by an interruption to visual development. Occlusion of the better eye by patching is the mainstay of treatment, so forcing use, of the affected eye. We have little understanding of how much treatment is required for improvement, so occlusion may continue for many months. This is both demanding for the child and family as a whole. Treatment outcome is frequently unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment the child actually receives or how much is required.

To overcome this, we have designed an instrument that permits us to measure occlusion: an occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child actually receives. Recently we have observed that 75% of improvement induced by occlusion occurs in the first four weeks of treatment. In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - i.e. treatment will be more efficient, more effective, and more 'family-friendly'. The study hypothesis is that 12 hours/day of patching is more effective than 6 hours/day.


Options:
A: Inclusion Criteria:

* Age 3 to \< 10 years
* Amblyopia associated with strabismus, anisometropia, or both
* No ocular cause apparent for reduced visual acuity
* Visual acuity 20/40 to 20/80 (71 to 54 letters inclusive) in amblyopic eye
* Visual acuity 20/40 or better (\>= 69 letters) in sound eye
* Interocular difference \>= 3 logMAR lines (\>= 15 letters)
* No amblyopia treatment other than spectacles in last 6 months

  \*Any treatment more than 6 months prior to enrollment is acceptable
* Currently wearing spectacles
* Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual acuity documented to be stable
* No myopia \> -6.00 D spherical equivalent in either eye
* Cycloplegic refraction within 6 months prior to enrollment
* Ocular examination within 6 months prior to enrollment

Exclusion Criteria:

* Current vision therapy or orthoptics
* Ocular cause for reduced visual acuity
* Prior intraocular or refractive surgery
* Known skin reactions to patch or bandage adhesives
B: 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)
C: Inclusion Criteria:

* 3 to 8 years of age;
* Presence of anisometropia and/or strabismus;
* inter-ocular acuity difference of at least 0.1 logMAR
* parental consent

Exclusion Criteria:

* history of previous occlusion therapy
* ocular pathology
* learning difficulties
D: 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

Answer: C