CompletedNot Applicable

A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming

United States92 participantsStarted 2019-05-07

Plain-language summary

The research team will execute two concurrent studies within a common framework. The first will compare iCare to standard of care occlusion therapy (patching) for amblyopia in patients ages 4 to 18 (inclusive). The second will compare iCare to a standard of care for home-based CI therapy (pencil pushups) for convergence insufficiency patients ages 8 to 18 (inclusive). In the context of this study, the term iCare refers to either the amblyopia or CI video game module as appropriate for the respective study group.

Who can participate

Age range

4 Years – 18 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 (Amblyopia Arms): * Age 4 to 18 (inclusive); * Diagnosis of amblyopia associated with anisometropia; * No amblyopia treatment (atropine, patching, vision therapy) in the past two weeks; * Spectacles (if required) worn for at least 16 weeks, or demonstrated stability of visual acuity (\< 0.1 logMAR change by the same testing method measured on two exams at least four weeks apart); * Visual acuity in the amblyopic eye of 20/40 or worse; * Visual acuity in the fellow eye of 20/25 or better; * Interocular difference ≥ 0.3 logMAR (3 logMAR chart lines); * No myopia greater than -6.00D spherical equivalent in either eye; * Demonstrate in-office ability to play the iCare training game under binocular condition Exclusion Criteria (Amblyopia Arms): * Prism in the refractive correction at time of enrollment; * Previous intraocular or refractive surgery; * Any treatment for amblyopia in the past two weeks; * Down syndrome or cerebral palsy or other severe developmental delay that would interfere with treatment or evaluation; * Heterotropia or heterophoria with a total ocular deviation \> 10∆ at near. Inclusion Criteria (CI Arms): * Best-corrected visual acuity of ≥ 20/25 in each eye at distance and near; * Exophoria at near at least 4∆ greater than at distance; * Reduced positive fusional convergence at near (\< 20∆ or fails Sheard's criterion that the PFV measures less than twice the magnitude of the near phoria); * Near point of convergence of ≥ 6 cm break; * C…

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

Visual Acuity

Timeframe: Pre- to post-intervention change in best-corrected vision (delta-logMAR) at 12 weeks

Positive Fusional Vergence (PFV) Base-Out Breakpoint (BOB)

Timeframe: Pre- to post-intervention change in BOB (delta-BOB) at 12 weeks

Trial details

NCT IDNCT03066063

SponsorBarron Associates, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

Results submitted2023-09-01

View on ClinicalTrials.gov More Amblyopia trials