Virtual Reality Visual Field Testing for Eye Diseases

Overseen By Sharon F Freedman, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Developmental delay, Ocular diseases, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure peripheral vision using goggles instead of traditional equipment. The goal is to compare this virtual reality test, called VisuALL, with the standard Humphrey Visual Field test. The study includes healthy children and those with eye conditions who already require vision testing as part of their regular care. Participants must be at least four years old, able to wear the goggles for 10 minutes, and free of eye diseases that interfere with the test. The trial takes about 30 minutes and provides a parking pass as compensation. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance vision testing methods for future patients.

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 unlikely, as the study focuses on visual field testing and does not involve medication.

What prior data suggests that this virtual reality visual field testing device is safe for eye disease patients?

Research has shown that the VisuALL virtual reality system is safe for both adults and children. Past studies have used this system for vision testing without linking it to any physical harm. The test is non-invasive, meaning it does not touch the eyes or require eye drops. No known side effects arise from the test itself. The primary concern involves potential privacy risks, as with any medical data. Overall, the VisuALL system is well-tolerated and does not pose significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to conduct visual field tests using virtual reality technology. Unlike traditional methods, like the Humphrey Visual Field Test, which require bulky equipment and a clinical setting, the VisuALL Virtual Reality Visual Field offers a more portable and potentially more accessible solution. This innovative approach could make it easier for patients to undergo eye disease testing outside of traditional settings, possibly even from the comfort of their own homes. Moreover, by comparing results from both traditional and virtual reality tests, researchers hope to verify the effectiveness and accuracy of this new method, potentially leading to advancements in how we diagnose and monitor eye diseases.

What evidence suggests that this virtual reality visual field testing is effective for eye diseases?

Research has shown that the VisuALL virtual reality visual field test is as reliable and effective as the standard Humphrey Visual Field (HVF) test for detecting vision problems. In this trial, participants in the patient (pathology) group will perform both the standard HVF test and the VisuALL VR test, while the control group will only perform the VisuALL VR test. Studies have found that VisuALL matches the accuracy of traditional methods but offers more convenience and comfort by using VR goggles instead of large machines. The results from the VR test closely align with those from the Humphrey test, commonly used for eye exams. Additionally, the VR test is typically quicker and easier to complete. Early findings suggest VisuALL could be a promising option for both children and adults who need regular eye exams. ^{5 6 7 8 9}

Who Is on the Research Team?

Sharon F Freedman, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children and young adults up to 21 years old with eye diseases affecting peripheral vision. Participants must be cognitively normal, able to understand English, and tolerate wearing virtual reality goggles. Consent from a parent or guardian is required.

Inclusion Criteria

Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)

I do not have any eye diseases that could affect vision tests.

Cognitively normal (no developmental delay or syndrome)

Exclusion Criteria

Inability to obtain consent

Developmental delay

Inability to understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Office Visit Testing

Participants undergo visual field testing using both the VisuALL and Humphrey Visual Field (HVF) tests during a scheduled eye appointment

1 day

1 visit (in-person)

Home Testing

Selected participants are trained and loaned a home VisuALL system for visual field testing at home

1 month

1-2 tests per week

Follow-up

Participants are monitored for satisfaction and usability of the VisuALL system

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Visual Field Testing
• Visual Field Test

Trial Overview

The study tests VisuALL, an FDA-approved virtual reality system for visual field testing, against the standard Humphrey Visual Field test. It aims to see if this new method can effectively measure peripheral vision in a more convenient way.

How Is the Trial Designed?

Group I: Patient (pathology) group Experimental Treatment 2 Interventions

This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field.

Group II: Control group Experimental Treatment 1 Intervention

This group will only perform the VisuALL Virtual Reality Visual Field.

Visual Field Test is already approved in United States for the following indications:

Approved in United States as VisuALL for:

• Visual field testing for eye conditions

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A new visual field examination method using virtual reality glasses was tested on 10 patients, showing a high correlation (r=0.808) with traditional Humphrey perimeter results, indicating its reliability.

The study suggests that this virtual reality method could be a suitable alternative for clinical use in assessing visual fields, particularly for patients in glaucoma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual field examination method using virtual reality glasses compared with the Humphrey perimeter. Tsapakis, S., Papaconstantinou, D., Diagourtas, A., et al.[2022]

Visual field testing is crucial for diagnosing and monitoring ocular and neurological diseases, despite being a subjective method.

Understanding the equipment and potential error-inducing factors is essential for conducting accurate visual field exams, as discussed in the context of using Optopol and Humphrey perimeters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Practical aspects of automated perimetry]. Stan, C.[2014]

The novel visual field application on a portable augmented-reality headset shows excellent correlation with the standard Humphrey field analyzer, with a Pearson correlation coefficient of 0.94 for mean sensitivity and 0.95 for mean deviation, based on a study of 89 patients.

The analysis indicates that the Heru visual field test has a small mean difference compared to the Humphrey test, suggesting it is a reliable alternative for assessing visual fields in patients with and without glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Visual Field Test Measurements With a Novel Approach on a Wearable Headset to Standard Automated Perimetry. Johnson, C., Sayed, A., McSoley, J., et al.[2023]

The Humphrey 24-2C visual field test, which includes 10 additional test points in the central 10° of vision, showed similar effectiveness to the standard 10-2 test in detecting central visual field defects among 25 neuro-ophthalmology patients (42 eyes).

Both tests flagged a comparable number of total deviation and pattern deviation points, indicating that the 24-2C can serve as a useful hybrid tool for evaluating visual field defects without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing the 24-2C Visual Field Test in Neuro-Ophthalmology. Yamane, MLM., Odel, JG.[2023]

The Humphrey visual field analyzer's foveal threshold test is a reliable method for estimating best-corrected visual acuity, showing strong correlations with both uncorrected and best-corrected visual acuity in a study of 117 eyes from 59 patients.

The study found that a significant percentage of eyes with lower visual acuity (<20/50) had foveal thresholds indicating poorer vision, while those with better visual acuity (>20/20) had higher foveal thresholds, suggesting this test can help identify potential nonorganic visual acuity loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between foveal threshold and visual acuity using the Humphrey visual field analyzer. Flaxel, CJ., Samples, JR., Dustin, L.[2010]

The GlauCUTU virtual reality visual field test significantly reduces testing time by an average of 354 seconds compared to the traditional Humphrey Visual Field Analyzer, which helps minimize eye fatigue during testing.

This new VR-based system effectively differentiates between normal and glaucomatous eyes, making it a promising, portable, and cost-effective option for glaucoma screening, especially in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GlauCUTU: Virtual Reality Visual Field Test. Kunumpol, P., Lerthirunvibul, N., Phienphanich, P., et al.[2022]

A study involving 59 patients with bilateral glaucoma demonstrated that a simulated central binocular visual field, created from individual monocular tests, effectively identifies patients with significant visual field defects relevant to driving safety.

The simulation showed excellent agreement with the established binocular Humphrey Esterman visual field test, achieving 100% sensitivity and 86% specificity in detecting central defects, allowing for quick assessments without additional testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulating binocular visual field status in glaucoma. Crabb, DP., Viswanathan, AC., McNaught, AI., et al.[2022]

A study involving 33 normal subjects established that the inner ring of the peripheral visual field shows the highest consistency in sensitivity measurements, making it a key area for detecting visual abnormalities.

The research identified that the nasal area of the outer ring had the lowest sensitivity and highest variability, suggesting that this region may be less reliable for assessing peripheral vision compared to the inner and temporal zones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral visual field thresholds using Humphrey Field Analyzer program 60-4 in normal eyes. Berezina, TL., Khouri, AS., Kolomeyer, AM., et al.[2017]

The 24-2 Humphrey visual field (HVF) strategy provides comparable information to the 30-2 strategy in patients with optic nerve disease, with 95-100% agreement in readings across various patient groups, indicating its reliability.

The 24-2 strategy not only reduces testing time by 28% but also shows less variability in results, making it a more efficient option for visual field testing, although the 30-2 strategy may still be necessary for certain conditions like idiopathic intracranial hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 24-2 and 30-2 perimetry in glaucomatous and nonglaucomatous optic neuropathies. Khoury, JM., Donahue, SP., Lavin, PJ., et al.[2010]

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