CompletedNot Applicable

Binocular Dig Rush Game Treatment for Amblyopia

United States, Canada320 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 range

4 Years – 12 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

4 Years – 12 Years

Sex

ALL

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.

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