Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2027-03-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Convergence Insufficiency Traumatic Brain Injury Concussion, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each of these participant cohorts (Control and TBI with CI \[PTCI\]) will be randomly halved to generate a total of four cohorts for a semi-crossover study design: 1) BNC Active, 2) BNC Sham \[Placebo\], 3) PTCI Active, and 4) PTCI Sham \[control group\]. PTCI participants in Sham will later undergo active therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Only the clinical coordinators and technicians (programming the therapy) will know the therapy type. Investigators, clinical examiners, and data analysts, will be masked to therapy type until performing group level analysis.

Study Groups

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BNC Active

Binocularly normal controls receiving active therapy

Group Type EXPERIMENTAL

Virtual Eye Rotation Vision Exercise (VERVE)

Intervention Type DEVICE

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.

BNC Sham

Binocularly normal controls receiving sham therapy

Group Type SHAM_COMPARATOR

Sham VR Therapy

Intervention Type DEVICE

VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

PTCI Active

Post-traumatic Convergence Insufficiency participants receiving active therapy

Group Type EXPERIMENTAL

Virtual Eye Rotation Vision Exercise (VERVE)

Intervention Type DEVICE

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.

PTCI Sham

Post-traumatic Convergence Insufficiency participants receiving sham therapy

Group Type SHAM_COMPARATOR

Sham VR Therapy

Intervention Type DEVICE

VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Interventions

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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.

Intervention Type DEVICE

Sham VR Therapy

VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Intervention Type DEVICE

Other Intervention Names

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Virtual Reality Vergence Exercises Vergency Therapy

Eligibility Criteria

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Inclusion Criteria

1. are aged 18 - 40;
2. 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;
3. were injured between 1 month and 15 years ago;
4. received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;
5. experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
6. 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);
7. have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
8. 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;
9. are fluent in English; and
10. have been on stable doses of any vision-altering medications for the past 2 months.
11. Stereopsis of 500 sec arc using Randot Stereo Test.
12. Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
13. Near point of convergence (NPC) \> 5 cm
14. Convergence amplitude at near \< 15PD break or the Sheard criterion not met

1. are aged 18 - 40;
2. CISS score of 20 or lower;
3. near point of convergence (NPC) \< 6cm; and
4. positive fusional range \>15 prism diopters.
5. Stereopsis of 500 sec arc using Randot Stereo Test.

Exclusion Criteria

1. prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
2. history of psychosis, as there are known visual performance findings associated with psychosis;
3. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
4. recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
5. any condition that would prevent the participant from completing the protocol;
6. appointment of a legal representative, to avoid coercion of a vulnerable population;
7. any ongoing litigation related to TBI, to prevent interference with legal proceedings;
8. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
9. Previous vergence therapy, orthoptics, home-based therapy, etc.
10. Amblyopia or constant strabismus or strabismus surgery.
11. High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \>1.5PD difference between eyes; Prior refractive surgery.
12. Manifest or latent nystagmus evident clinically.
13. Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes