VR Technology for Pupil Disorders

(RAPD Trial)

Overseen By Stacy M Schreiber Lopez, AA, BS, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Congenital pupil defects, Traumatic pupils, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect a pupil condition called Relative Afferent Pupillary Defect (RAPD). Researchers aim to determine if a virtual reality headset combined with machine learning can identify RAPD more reliably than the traditional "swinging flashlight test," a standard eye examination method. The trial is open to individuals with eye disorders such as glaucoma or diabetic retinopathy who have been referred by their eye doctor. Participants will undergo the standard test and then use the new VR method for comparison. The goal is to determine if the VR method can detect RAPD earlier and more accurately. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance early detection methods for eye conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device for eye conditions, so it's unlikely to require changes to your medication, but you should confirm with the study team.

What prior data suggests that this VR technology is safe for detecting pupil disorders?

A previous study showed that using a virtual reality headset did not change vision, though some people found it slightly harder to focus on nearby objects. This suggests that while the headset is generally safe, prolonged use might cause slight focusing difficulties for a few individuals.

Other research has shown that the safety of these headsets depends on usage. Factors such as screen type and duration of use can affect safety. Generally, these devices are well-tolerated, but following usage guidelines is important.

Overall, virtual reality headsets are considered safe for detecting eye conditions like Relative Afferent Pupillary Defect (RAPD). Participants should feel comfortable using them in this study but should report any discomfort to the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality Head-Mounted Displays (VR HMDs) for diagnosing pupil disorders because this technology offers a new way to assess pupil responses. Unlike traditional methods that rely on manual measurements during a swinging light test, the VR HMD provides a more standardized and potentially automated approach. This could lead to more accurate and consistent assessments of Relative Afferent Pupillary Defect (RAPD). Additionally, integrating machine learning with VR technology might improve diagnostic precision, making it easier to detect subtle changes in pupil response that are often missed with conventional techniques.

What evidence suggests that this VR technology is effective for detecting RAPD?

Research has shown that virtual reality headsets can effectively detect certain eye issues called relative afferent pupillary defects (RAPD). One study found that using these headsets for eye tests was practical and promising in spotting RAPD. In this trial, participants will undergo the standard swinging light test followed by the light test using the Virtual Reality Head-Mounted Display (VR HMD) with machine learning. This technology employs machine learning, a type of artificial intelligence that learns from data, to measure pupil reactions more accurately than traditional methods. It could help identify RAPD earlier than the usual flashlight test, leading to faster diagnosis. While more research is needed, these early results suggest that virtual reality headsets could reliably identify RAPD. ^{2 5 6 7 8}

Who Is on the Research Team?

Kevin H Merkley, MD, MBA

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for UTMB clinic patients aged 18-85 with known Relative Afferent Pupillary Defect (RAPD) or vision disorders like glaucoma. It's not for those outside this age range, non-English speakers, people uncomfortable with VR devices or glasses, and those with congenital pupil issues.

Inclusion Criteria

This criterion refers to the exclusion of 60 patients with known Relative Afferent Pupillary Defect (RAPD).

I have been diagnosed with a vision disorder like glaucoma or diabetic retinopathy.

Referred to study by treating eye doctor

Exclusion Criteria

You have a history of pupils being abnormal due to birth or injury.

Those whose pupils were dilated during the standard of care examination deemed by treating eye doctor not to be eligible to participate in study

You have trouble wearing glasses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo the standard of care swinging flashlight test and manual pupil measurements

1 day

1 visit (in-person)

Intervention

Participants undergo testing with the VR HMD and ML algorithms to measure pupillary response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post-intervention

1 day

No additional visits required

What Are the Treatments Tested in This Trial?

Interventions

• Swinging Light test
• Virtual Reality Head-Mounted Display (VR HMD)

Trial Overview

Researchers are testing if a virtual reality headset combined with machine learning can detect RAPD more reliably and earlier than the standard swinging flashlight test. Participants will undergo both methods to compare effectiveness.

How Is the Trial Designed?

Group I: No Known RAPD Experimental Treatment 2 Interventions

Participants with no known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.

Group II: Known RAPD Experimental Treatment 2 Interventions

Participants with known RAPD will be administered the standard of care swinging light test and pupil measurements taken manually, then administered the light test using the VR HMD and ML.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

University of Nevada, Reno

Collaborator

Trials

34

Recruited

20,200+

Published Research Related to This Trial

A new head-mounted VR display with gaze-contingent flicker pupil perimetry (VRgcFPP) was tested on 20 children aged 3-11 years, showing it effectively measures visual field responses while allowing children to move freely and engage with the task.

The fixation counting task was found to be the most effective method for eliciting strong pupil responses, as children enjoyed it the most, indicating it could be the best practice for assessing visual fields in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining fixation by children in a virtual reality version of pupil perimetry. Portengen, BL., Naber, M., Jansen, D., et al.[2023]

A study involving 42 young adults showed that playing a fast-paced virtual reality game for 25 minutes significantly improved binocular accommodative facilities by an average of 4.67 cycles per minute (cpm) and vergence facilities by 3.72 cpm.

The experimental group demonstrated a statistically significant improvement in both accommodative and vergence facilities compared to a control group watching a film, suggesting that VR gaming could be a viable method for treating visual function issues, although further research is needed due to the study's limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study to Assess the Feasibility of Utilising Virtual Reality for the Treatment of Accommodative and Vergence Infacility. Munsamy, A., Paruk, H.[2022]

Virtual Reality (VR) has been shown to effectively enhance motor and functional skills in both children and adults, leveraging brain plasticity to improve cognitive function and motor disabilities in various neurological disorders.

Clinical studies indicate that VR training can significantly improve visual functions such as stereopsis and visual acuity in ophthalmological conditions, offering a non-invasive alternative to traditional methods that require eye occlusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review: Virtual-reality-based techniques for human exercises and health improvement. Ali, SG., Wang, X., Li, P., et al.[2023]

The study successfully tested a virtual reality headset for assessing ocular misalignment, showing that it can provide results consistent with traditional methods like the Lees screen.

This innovative approach eliminates the need for fixed head positions and allows for better control over testing conditions, suggesting it could enhance the diagnosis and monitoring of strabismus in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepping into the virtual unknown: feasibility study of a virtual reality-based test of ocular misalignment. Nesaratnam, N., Thomas, P., Vivian, A.[2018]

Current VR headsets have a minimum angular resolution of 0.41 logMAR on average, which is inadequate for reliable visual acuity testing and may not be suitable for treating conditions like amblyopia.

The average field of view for VR headsets is about 50.2°, which is significantly lower than manufacturer claims, but it may still be sufficient for certain visual field tests, although concerns exist for vergence testing due to varying eye-to-screen distances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications. Lynn, MH., Luo, G., Tomasi, M., et al.[2021]

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