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

Trial Summary

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 data supports the effectiveness of the treatment Virtual Reality Visual Field Testing for Eye Diseases?

Research shows that virtual reality visual field tests, like the GlauCUTU VF test, can provide results comparable to the traditional Humphrey Visual Field test, with faster completion times. This suggests that virtual reality methods can be an effective and efficient alternative for assessing visual fields in eye diseases. ^{1 2 3 4 5}

Is Virtual Reality Visual Field Testing safe for humans?

The research does not provide specific safety data for Virtual Reality Visual Field Testing, but it is generally used as a diagnostic tool similar to the Humphrey Visual Field test, which is widely used and considered safe for assessing visual fields in various eye conditions. ^{1 3 6 7 8}

How is the Virtual Reality Visual Field Test different from other treatments for eye diseases?

The Virtual Reality Visual Field Test is unique because it uses VR headsets to conduct visual field tests, offering a faster and potentially more engaging experience compared to the traditional Humphrey Visual Field Analyzer, which is the current standard. ^{1 3 4 6 9}

What is the purpose of this trial?

The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test. The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants. Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.

Research Team

Sharon F Freedman, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

GlauCUTU: Virtual Reality Visual Field Test. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Relationship between foveal threshold and visual acuity using the Humphrey visual field analyzer. [2010]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of 24-2 and 30-2 perimetry in glaucomatous and nonglaucomatous optic neuropathies. [2010]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Visual field examination method using virtual reality glasses compared with the Humphrey perimeter. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Visual Field Test Measurements With a Novel Approach on a Wearable Headset to Standard Automated Perimetry. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Introducing the 24-2C Visual Field Test in Neuro-Ophthalmology. [2023]

7. Romania pubmed.ncbi.nlm.nih.gov

[Practical aspects of automated perimetry]. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Peripheral visual field thresholds using Humphrey Field Analyzer program 60-4 in normal eyes. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Simulating binocular visual field status in glaucoma. [2022]