Virtual Reality Therapy for Convergence Insufficiency
(iRAPID Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new virtual reality (VR) system called VERVE, designed to improve vision problems following a mild traumatic brain injury (mTBI). The study evaluates the effectiveness of this VR therapy for Veterans with post-traumatic convergence insufficiency (difficulty focusing both eyes together) compared to a control group with normal vision. The trial includes two groups: one receiving the actual treatment and another receiving a sham (fake) treatment to determine if the VR system truly helps. Veterans with ongoing vision issues after a mild brain injury might be suitable candidates for this trial. As an unphased trial, it offers Veterans the chance to explore innovative treatment options for vision issues.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must have been on stable doses of any vision-altering medications for the past 2 months to participate.
What prior data suggests that the VERVE system is safe for use in vergence therapy?
Research has shown that vision therapy, such as the VERVE system being tested, is generally manageable for participants. In earlier studies, about 90% of patients experienced vision improvement after 12 weeks of therapy. This suggests the treatment is effective and safe for many users.
No major reports of serious side effects have emerged. Most participants in these studies did not experience significant negative reactions. This is encouraging for prospective participants, as it indicates a high level of safety for this type of therapy. For those considering participation in this trial, the evidence so far shows that similar treatments have been safe for other participants.12345Why are researchers excited about this trial?
Researchers are excited about the techniques being explored in the iRAPID trial for post-traumatic convergence insufficiency because they focus on innovative therapy methods that could enhance recovery. Unlike current treatments that rely on exercises or prism glasses, these new approaches involve active and sham therapies designed to specifically target binocular control more effectively. The active therapy in particular aims to improve eye coordination and function more quickly and efficiently than traditional methods, potentially offering a faster path to recovery for those with post-injury eye dysfunction.
What evidence suggests that the VERVE system is effective for vergence therapy in post-traumatic convergence insufficiency?
Research shows that the Virtual Eye Rotation Vision Exercises (VERVE) platform, which uses virtual reality and eye tracking, might help with post-traumatic convergence insufficiency (PTCI). In this trial, participants with PTCI will receive either active therapy or sham therapy. Studies indicate that exercises to improve eye coordination can increase brain activity and reduce symptoms like trouble focusing. Previous research on vision therapy has successfully treated convergence insufficiency (CI) in both children and adults, with participants often finding it easier to focus on nearby objects. Overall, evidence suggests that virtual reality eye exercises could be a promising way to help those with PTCI improve their vision.15678
Who Is on the Research Team?
Chang Yaramothu, PhD
Principal Investigator
New Jersey Institute of Technology
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Active and Sham therapy using the VERVE platform for vergence therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sham VR Therapy
- Virtual Eye Rotation Vision Exercise (VERVE)
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Post-traumatic Convergence Insufficiency participants receiving active therapy
Binocularly normal controls receiving active therapy
Binocularly normal controls receiving sham therapy
Post-traumatic Convergence Insufficiency participants receiving sham therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
New Jersey Institute of Technology
Lead Sponsor
U.S. Army Medical Research and Development Command
Collaborator
Biomedical Research Institute of New Mexico
Collaborator
University of New Mexico
Collaborator
New Mexico VA Healthcare System
Collaborator
Citations
CONCUSS clinical trial fMRI results - PMC - PubMed Central
Results support that OBVAM improves functional brain activity in CONC-CI correlated with NPC, PFV, and VF. Keywords: concussion, convergence ...
NCT06105892 | Eye Recovery Automation for Post Injury ...
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE).
Vision Therapy in Adults with Convergence Insufficiency
The results of these studies demonstrate that office-based vision therapy with home reinforcement is the most effective treatment for CI in children and adults.
Near Point of Convergence Deficits and Treatment ...
All of the studies demonstrated NPC break values were lower (better) after therapy. All of the studies, except for the case study, statistically ...
5.
ctv.veeva.com
ctv.veeva.com/study/persistent-post-concussion-symptoms-with-convergence-insufficiencyPersistent Post-Concussion Symptoms With Convergence ...
The first outcome measurement will be attained by a masked optometrist. Then, the participant will have 2 more weeks of therapy (4 office-based ...
Scoping review: Intervention for ocular motor disorders in ...
Among the studies providing statistically supported results, improvements in one or more ocular motor outcome domains were reported in nearly 80 ...
Physical Therapy Evaluation and Treatment After ...
An exploration of the impact of initial timing of physical therapy on safety and outcomes after concussion in adolescents. J Neurol Phys Ther. 2018;42:123 ...
Vision Therapy Restores Sight in Post-Concussion Eye ...
Therapy Success: 90% of patients improved with 12 weeks of vision therapy compared to under 10% without treatment. Brain Changes: fMRI scans ...
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