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

Both the amblyopia and CI studies will follow the same basic approach. Each study will last 12 weeks, and participants will return for follow-up visits at Weeks 4, 8, and 12. Patients will receive full visual exams to establish baseline data upon enrollment, and again at Week 12 to record post-treatment data. During the interim visits (Weeks 4 and 8), patients' visual function will be assessed by a study optometrist, and any changes to the iCare configuration will be addressed as needed. As iCare is a home-based therapy, participants must have access to a personal computer and the Internet. For patients without access, the research team will provide loaner computers and/or pre-paid Verizon wireless mobile hotspots for Internet connectivity.

The proposed clinical studies will use the provider-as-investigator model that involves a minimum of 10 study sites and approximately 100 participants (see statistical power analysis below). With this approach, the research team will recruit optometry and vision therapy clinics and practices from around the country to support study execution under the training, guidance, and supervision of the iCare team. UND will serve as the coordinating center, enrolling, training, and overseeing the study sites and providing Institutional Review Board (IRB) governance.

The proposed effort is a Continuing Renewal application, with commercialization of the iCare product as its ultimate goal. By putting the iCare system directly in the hands of practicing optometrists and vision therapists, the research team can solicit feedback on features, commercialization models, and patient experiences. This will help ensure rapid transition of the test system to commercial adoption at the conclusion of the research effort.

A total of 10 centers from across the country have already provided letters of support indicating strong interest in participating (see letters of support herein). This demonstrates the breadth of outreach that has been conducted within the provider community as well as the high level of enthusiasm that exists for the iCare solution. Providers want access to this technology. Although all investigator-providers will be highly credentialed, qualified, and experienced vision therapy practitioners, not all will be experienced researchers. To ensure protection of human subjects, integrity of data, and reliability of results, the UND-Barron Associates team will: provide rigorously-complete step-by-step checklists for all procedures; conduct webinar-based training on detailed protocols; and promulgate specific instructions on data protection, patient safety, and research ethics. All investigator-providers will complete Collaborative Institutional Training Initiative (CITI) training and be registered with the UND IRB. During interactive online video training sessions, iCare team members will provide detailed instructions regarding study protocols to investigator-providers, including consent administration, inclusion/exclusion criteria, and assessments. Barron Associates, Inc. will provide thorough instructions on installation and use of the iCare system, the Provider Dashboard web app, and the parental-support web app. These will also be documented in printed manuals and online "how-to" videos. Each training webinar is expected to last 4 hours, with one-on-one "just-in-time" training available at any time. Follow-up teleconferences with the investigator-providers during study execution will reinforce patient protections and protocol adherence, as well as solicit recommendations on feature enhancements and integration of iCare into provider workflows.

The amblyopia and convergence insufficiency branches of the study will run concurrently at the participating study sites. Study details specific to each are described below.