CompletedNot Applicable

Binocular Dig Rush Game Treatment for Amblyopia

United States320 participantsStarted 2017-03-02

Plain-language 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.

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 4 to \<13 years
✓. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
✓. Criteria for strabismic amblyopia: At least one of the following must be met:
✓. Criteria for anisometropia: At least one of the following criteria must be met:
✓. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
✓. 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):
✓. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

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.
✕. 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).
✕. No Down syndrome or cerebral palsy
✕. 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.
✕. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)

What they're measuring

Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort

Timeframe: Baseline and 4 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)

Timeframe: 4 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort

Timeframe: Baseline and 8 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)

Timeframe: 8 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort

Timeframe: baseline and 4 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)

Timeframe: 4 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort

Timeframe: Baseline and 8 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)

Timeframe: 8 weeks

Trial details

NCT IDNCT02983552

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-20

Results submitted2020-12-17

View on ClinicalTrials.gov More Amblyopia trials

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 4 to \<13 years
✓. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
✓. Criteria for strabismic amblyopia: At least one of the following must be met:
✓. Criteria for anisometropia: At least one of the following criteria must be met:
✓. Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
✓. 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):
✓. Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

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.
✕. 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).
✕. No Down syndrome or cerebral palsy
✕. 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.
✕. Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)

What they're measuring

Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort

Timeframe: Baseline and 4 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)

Timeframe: 4 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort

Timeframe: Baseline and 8 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)

Timeframe: 8 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort

Timeframe: baseline and 4 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)

Timeframe: 4 weeks

Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort

Timeframe: Baseline and 8 weeks

Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)

Timeframe: 8 weeks