Eye Recovery Automation for Post Injury Dysfunction

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• are aged 18 - 40;

• have suffered a mTBI according to VA/Department of Defense (DoD) criteria with documented evidence of alteration of consciousness (AOC) \< 24 hours or loss of consciousness (LOC) less than 30 minutes;

• were injured between 1 month and 15 years ago;

• received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;

• experienced less than 24 hours of post-traumatic amnesia (PTA), if any;

• have ongoing post-concussive symptoms as evidenced by a score of 18 or greater or a score of 2 or greater on question 6 (vision problems, blurring, trouble seeing) on the Neurobehavioral Symptom Inventory (NSI);

• have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);

• have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a specific measure of convergence insufficiency;

• are fluent in English; and

⁃ have been on stable doses of any vision-altering medications for the past 2 months.

⁃ Stereopsis of 500 sec arc using Randot Stereo Test.

⁃ Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance

⁃ Near point of convergence (NPC) \> 5 cm

⁃ Convergence amplitude at near \< 15PD break or the Sheard criterion not met

• are aged 18 - 40;

• CISS score of 20 or lower;

• near point of convergence (NPC) \< 6cm; and

• positive fusional range \>15 prism diopters.

• Stereopsis of 500 sec arc using Randot Stereo Test.

Locations
United States
New Mexico
New Mexico VA Health Care System
RECRUITING
Albuquerque
Contact Information
Primary
Chang Yaramothu, PhD
cy53@njit.edu
9736424844
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2027-03-20
Participants
Target number of participants: 100
Treatments
Experimental: BNC Active
Binocularly normal controls receiving active therapy
Sham_comparator: BNC Sham
Binocularly normal controls receiving sham therapy
Experimental: PTCI Active
Post-traumatic Convergence Insufficiency participants receiving active therapy
Sham_comparator: PTCI Sham
Post-traumatic Convergence Insufficiency participants receiving sham therapy
Related Therapeutic Areas
Sponsors
Collaborators: University of New Mexico, Biomedical Research Institute of New Mexico, U.S. Army Medical Research and Development Command, New Mexico VA Healthcare System
Leads: New Jersey Institute of Technology

This content was sourced from clinicaltrials.gov