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:

* 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
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:

* 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:

* Age \< 7 years
* Able to measure surrounded single optotype visual acuity using the ATS single-surround HOTV protocol (this will in effect exclude all patients \<2 years old and many \<3 years old)
* Amblyopia associated with strabismus, anisometropia, or both
* If anisometropia is present (as per protocol definition), refractive error corrected with spectacles for a minimum of 4 weeks
* Visual acuity in the amblyopic eye \< 20/40 and \>20/80
* Visual acuity in the sound eye \> 20/40 and inter-eye acuity difference \>3 logMAR lines

Exclusion Criteria:

* Amblyopia treatment (other than spectacles) in the past month and no more than one month of amblyopia treatment in the past 6 months
* Myopia more than a spherical equivalent of -6.00 D in the amblyopic eye
* Myopia more than a spherical equivalent of -0.50 D in the sound eye

Answer: C