Please select the eligibility criteria that correspond to the clinical trial below.
Title: Binocular Dig Rush Game Treatment for Amblyopia
Brief Summary: To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.


Options:
A: Inclusion Criteria:

1. Age 4 to \<13 years
2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)

   1. Criteria for strabismic amblyopia: At least one of the following must be met:

      * Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
   2. Criteria for anisometropia: At least one of the following criteria must be met:

      * ≥1.00 D difference between eyes in spherical equivalent
      * ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
   3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:

      * Criteria for strabismus are met (see above)
      * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
3. No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
4. Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):

   * Hypermetropia of 2.50 D or more by spherical equivalent (SE)
   * Myopia of amblyopic eye of 0.50D or more SE
   * Astigmatism of 1.00D or more
   * Anisometropia of more than 0.50D SE

   NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
   1. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

      * SE must be within 0.50D of fully correcting the anisometropia.
      * SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
      * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
      * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D.
      * Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
   2. Spectacle correction meeting the above criteria must be worn:

      * For at least 16 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
      * For determining VA stability (non-improvement):

        * The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
        * The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
        * Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children \< 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:

   1. VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
   2. VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)
   3. Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)
6. Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation \>5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)
7. Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%.
8. Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol.
9. Parent understands the protocol and is willing to accept randomization.
10. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
11. Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.

Exclusion Criteria:

1. Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
2. Myopia greater than -6.00D spherical equivalent in either eye.
3. Previous intraocular or refractive surgery.
4. Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA criteria are met).
6. No Down syndrome or cerebral palsy
7. No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
8. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)
B: 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
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:

1. Age 5 to \<17 years
2. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)

   1. Criteria for strabismus: At least one of the following must be met:

      * Presence of a heterotropia on examination at distance or near fixation (with or without spectacles)
      * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
   2. Criteria for anisometropia: At least one of the following criteria must be met:

      * ≥0.50 diopter (D) difference between eyes in spherical equivalent
      * ≥1.50 D difference between eyes in astigmatism in any meridian
   3. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:

      * Criteria for strabismus are met (see above)
      * ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference between eyes in astigmatism in any meridian
      * Note: the spherical equivalent requirement differs from that in the definition for refractive/anisometropic amblyopia
3. No amblyopia treatment in the past 2 weeks (patching, atropine, Bangerter, vision therapy)
4. Refractive correction (spectacles or contact lenses, if applicable) must meet the following criteria at enrollment and be based on a cycloplegic refraction that is not more than 7 months old.

   1. Requirements for Correction of Refractive Error:

      1. For subjects meeting criteria for strabismic (only) amblyopia (see 2.2.1 #2 above):

         • Hypermetropia, if corrected, must not be under-corrected by more than +1.50 D spherical equivalent, and the reduction in plus sphere must be symmetric in the two eyes.
      2. For subjects meeting criteria for anisometropic or combined-mechanism amblyopia (see 2.2.1 #2 above):

         * Spherical equivalent must be within 0.50 D of fully correcting the anisometropia
         * Hypermetropia must not be under-corrected by more than +1.50 D spherical equivalent, and reduction in plus must be symmetric in the two eyes
         * Cylinder power in both eyes must be within 0.50 D of fully correcting the astigmatism
         * Cylinder axis for both eyes must be within 6 degrees of the axis of the cycloplegic refraction when cylinder power is ≥1.00 D
   2. Refractive corrections meeting the above criteria must be worn for either:

      * 16 weeks or more or
      * Until visual acuity in amblyopic eye is stable (defined as 2 consecutive visual acuity measurements by the same testing method at least 4 weeks apart with \<1 line change (\<5 letters if E-ETDRS))
   3. Monocular or binocular contact lens wear is allowed provided the contact lenses meet the above refractive requirements at the corneal plane. The same form of correction must be worn throughout the entire study during study procedures (i.e., no changing between contacts and spectacles while patching or while game-playing or study testing). Safety glasses are not required for subjects wearing contact lenses, but investigators are encouraged to suggest safety glasses be worn over contact lenses.
5. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) within 7 days prior to randomization using the Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children \< 7 years and the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:

   1. Visual acuity in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters if E-ETDRS)
   2. Visual acuity in the fellow eye 20/25 or better (≥ 78 letters if E-ETDRS)
   3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters if E-ETDRS) (i.e., amblyopic-eye acuity at least 3 logMAR lines worse than fellow-eye acuity)
6. Heterotropia or heterophoria with a total near deviation of ≤ 10∆ (measured by PACT).
7. Ability to align the nonius cross on the binocular game system (angles of ocular deviation \>10∆ would require the nonius cross to be adjusted to such an extent that playing of the game would be compromised).
8. Subject is able to play Hess Falling Blocks game on the study iPad® (on easy setting) under binocular conditions (with red-green glasses), as demonstrated by scoring at least 1 line in the office.
9. Investigator is willing to prescribe computer game play or patching per protocol.
10. Parent understands the protocol and is willing to accept randomization.
11. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
12. Relocation outside of area of an active Pediatric Eye Disease Investigator Group (PEDIG) site for this study within the next 16 weeks is not anticipated.

Exclusion Criteria:

A subject is excluded for any of the following reasons:

1. Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
2. Myopia greater than -6.00 D spherical equivalent in either eye.
3. Previous intraocular or refractive surgery.
4. Any treatment for amblyopia (patching, atropine, Bangerter filter, or vision therapy) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks immediately prior to enrollment.
5. Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above visual acuity criteria are met).
6. No Down syndrome or cerebral palsy
7. No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
8. Heterotropia or heterophoria with a total ocular deviation \>10∆ (phoria plus tropia \>10∆) at near (measured by PACT).

Answer: A