Binocular Dig Rush Game Treatment for Amblyopia

Active Clinical Trials // Feb 12 2018

Binocular Dig Rush Game Treatment for Amblyopia (PEDIG ATS20 Protocol)

Sponsor: National Eye Institute (NEI)

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 with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.

Study Design:

Subjects will be randomly assigned with equal probability to either:

  • Binocular treatment group: binocular computer game play prescribed 1 hour per day 5 days a week (treatment time can be split into shorter sessions totaling 1 hour each day) with spectacles, if needed
  • Continued spectacle correction, if needed

Inclusion Criteria:

Major eligibility criteria include:

  • Age 4 to <13 years
  • Amblyopia associated with anisometropia, strabismus (<5Δ at near measured by SPCT), or both
  • No amblyopia treatment (atropine, patching, Bangerter, vision therapy, binocular therapy) in the past 2 weeks
  • Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart)
  • VA in the amblyopic eye 20/40 to 20/200
  • VA in the fellow eye 20/25 or better
  • Interocular difference ≥3 logMAR lines (ATS-HOTV) or (>15 letters ( E-ETDRS)
  • No myopia greater than -6.00D spherical equivalent in either eye
  • Demonstrate in-office ability to play the Dig Rush game under binocular conditions (with red-green glasses) on at least level 3, including ability to see red “diggers” and blue “gold carts” at 20% contrast in the non-amblyopic eye

Duration: 8 or 16 weeks depending on what treatment group originally assigned to by computer system

  • 8 weeks for subjects originally assigned to binocular game play
  • 8 or 16 weeks for subjects originally assigned to continued spectacle-wear (if applicable), subjects will be offered the binocular game play after 8 weeks if they choose to take part

 

For more information, contact Angie Adler 608-265-7557