Stopped: The study was terminated early for administrative reasons.
United States71 participantsStarted 2023-05-04
Plain-language summary
The goal of this prospective reliability study is to test the effectiveness of a commercially available, off-the-shelf virtual reality head-mounted display (VR HMD) and machine learning (ML) algorithms in detecting Relative Afferent Pupillary Defect (RAPD) in a group of subjects with known RAPD and another group with no known RAPD.
The main questions it aims to answer are:
* Does the use of the VR HMD and ML to replace the standard of care swinging flashlight test provide a more reliable and objective pupil measurement to detect RAPD?
* Can RAPD be detected by the VR HMD and ML algorithms at an earlier stage than the standard of care swinging light test?
Participants will be asked to undergo the standard of care swinging flashlight test, have their pupils manually measured, then have the test repeated using the VR HMD and ML.
Researchers will compare the measurements taken manually, following the standard of care swinging light test and those recorded by the VR HMD and ML to help answer the above questions.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 - 85
* 60 patients with known RAPD.
* 60 patients with no known RAPD
* May be diagnosed with a vision disorder such as glaucoma, diabetic retinopathy, unilateral or asymmetrical disease of the retina or other degenerative ocular diseases
* Referred to study by treating eye doctor
* Volunteered to participate in study
* UTMB clinic patients
* Not belonging to an identified vulnerable population
Exclusion Criteria:
* Younger than 18; older than 85 years of age
* Not a UTMB clinic patient
* Belonging to an identified vulnerable population
* Participants with discomfort using glasses
* Experience discomfort using VR HMD device
* Participants with history of congenital pupil defects, traumatic pupils
* Those whose pupils were dilated during the standard of care examination deemed by treating eye doctor not to be eligible to participate in study
* Participants who do not follow study directions and/or safety procedures given by investigators or lab assistants
* Participants who do not speak English to prevent a communication error during the informed consent process
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it ended early, and does that affect whether the pupillary measurement findings are reliable or useful for my care?
2Since this study was measuring relative afferent pupillary defect, how does RAPD testing factor into my own diagnosis or monitoring, and are there other ways my doctor is already assessing this in my case?
3Because this trial has no phase listed and was terminated, what does that mean for the evidence base around the measurement techniques it was testing — is this type of pupil testing considered established or still experimental in clinical practice?
4Are there any other active studies or newer approaches to measuring RAPD that my care team thinks might be more relevant to my situation than this terminated trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pupillary measurements
Timeframe: Immediately following the swinging light test or VR HMD light test
Trial details
NCT IDNCT05799066
SponsorThe University of Texas Medical Branch, Galveston