Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Full-time Bangerter Filters Versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children
Brief Summary: This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to \< 10 years.

Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity.

The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes.

The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model.

Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.


Options:
A: 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
B: Inclusion Criteria:

* Age 7 to 12 years old (inclusive)
* Amblyopia associated with strabismus, anisometropia, or both
* Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
* Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
* Interocular difference \>=15 letters (3 lines)
* Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

* Enrolled into the main study
* Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
* Birth weight \>1500 grams
* No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

* Amblyopia treatment (other than spectacles) in the last 6 months
* Myopia (more than -0.25D spherical equivalent) in either eye
C: 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
D: Inclusion criteria:

* Diagnosis of Anisometropic, Strabismic or Mixed Amblyopia as made by an Orthoptist
* Male or Female
* Aged 4 - 8 years inclusive.
* Participant's parent or guardian is willing and able to give informed consent for participation in the study

Exclusion criteria:

* Stimulus deprivation amblyopia.
* Organic lesions of the eye preventing the establishment of good vision (e.g. media opacities, abnormalities in the fundus or optic nerve).
* Lesions of the brain preventing the establishment of good vision (e.g. cortical visual impairment).
* Patients diagnosed with Photosensitive Epilepsy
* Patients diagnosed with or suspected of having Conjunctivitis
* Loss of suppression at filter 4 or less as measured with the Sbisa Bar
* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
* Inability to comply with the follow up visits required
* Refusal to accept randomisation
* Have participated in a previous study examining I-BiT treatment

Answer: C