AMBLYOPIA TREATMENT STUDY (ATS20)

Clinical Trials // Ongoing // Pediatrics // Yasmin Bradfield // Feb 12 2018

Binocular Dig Rush Game Treatment for Amblyopia 

  • Sponsor: Jaeb Center for Health Research
  • Principal Investigator: Yasmin Bradfield, MD
  • Study Coordinator: Angie Adler

Study objective:

To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction versus spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Study design:

The study will comprise two groups: amblyopia treatment using a special iPad game vs. continued glasses wear. The glasses group will be offered to play the iPad game after they complete 8 weeks of continued glasses wear. The study duration is up to 16 weeks and involves a voluntary questionnaire.

Inclusion criteria:

  • Age 4 to <13 years
  • Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
  • No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
  • 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
  • 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:
    • VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
    • VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)
    • Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)
    • 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.)

Exclusion criteria:

  • Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment)
  • Myopia greater than -6.00D spherical equivalent in either eye
  • Previous intraocular or refractive surgery
  • 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

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov