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New treatment option for Convergence Insufficiency
Official title Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
ClinicalTrials.gov ID: NCT06105892
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join if
- Mild Traumatic Brain Injury (mTBI) Cohort
- 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...
- 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;
You likely can't join if
- prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- history of psychosis, as there are known visual performance findings associated with psychosis;
- history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- any condition that would prevent the participant from completing the protocol;
- appointment of a legal representative, to avoid coercion of a vulnerable population;
See the full eligibility criteria
- Mild Traumatic Brain Injury (mTBI) Cohort
- 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 Control
- 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.
- prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- history of psychosis, as there are known visual performance findings associated with psychosis;
- history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- any condition that would prevent the participant from completing the protocol;
- appointment of a legal representative, to avoid coercion of a vulnerable population;
- any ongoing litigation related to TBI, to prevent interference with legal proceedings;
- membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
- Previous vergence therapy, orthoptics, home-based therapy, etc.
- Amblyopia or constant strabismus or strabismus surgery.
- High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \>1.5PD difference between eyes; Prior refractive surgery.
- Manifest or latent nystagmus evident clinically.
- Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).
The study team makes the final eligibility decision.
Where it's taking place
- Albuquerque, New Mexico, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albuquerque, New Mexico, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.