NCT06105892

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Eye Recovery Automation for Post Injury Dysfunction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: New Jersey Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.

Conditions

• Convergence Insufficiency
• Traumatic Brain Injury
• Concussion, Mild

Interventions

Type	Name	Description
DEVICE	Virtual Eye Rotation Vision Exercise (VERVE)	VERVE utilizes a virtual reality (VR) headset with integrated eye-tracking where the patient makes specific vergence eye movements by playing a VR game controlled by eye movements. Participants will be making convergence and divergence eye movements as steps and ramps.
DEVICE	Sham VR Therapy	VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Timeline

• Start date: 2023-10-23
• Primary completion: 2027-06-20
• Completion: 2027-09-20
• First posted: 2023-10-30
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study