Head-Mounted Visual Field Testing Device for Glaucoma

Not yet recruiting at 1 trial location

Overseen By Brennan Eadie, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brennan Eadie

Disqualifiers: Secondary glaucoma, Optic neuropathy, Anxiety, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new head-mounted device to determine its effectiveness in checking the visual fields of individuals with or at risk for glaucoma, a condition that damages the optic nerve and can lead to vision loss. The researchers aim to assess whether this new device performs as well as the standard equipment, the Humphrey Visual Field Analyzer. Participants will use both devices and provide feedback on comfort and satisfaction. Individuals with previous visual field tests showing normal results or various stages of glaucoma may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance glaucoma detection methods.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device, so it's unlikely that your medications will be affected, but you should confirm with the study team.

What prior data suggests that this head-mounted visual field testing device is safe for patients?

Research has shown that head-mounted devices for testing vision offer certain safety benefits. Studies have found that these devices increase patient comfort and reduce test duration, leading to better patient tolerance. Available studies report no specific negative effects from using these head-mounted vision tests, suggesting they are generally safe. Additionally, their portability makes them easy to use in various locations. Overall, head-mounted devices for vision testing appear to be a safe choice for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the head-mounted visual field testing device for glaucoma because it offers a new way to monitor the disease outside of traditional clinical settings. Unlike standard visual field tests, which require bulky equipment like the Humphrey Visual Field Analyzer, this portable device allows for more frequent testing at home. This could lead to earlier detection of changes in vision, improving the management of glaucoma by making it easier for patients to track their condition regularly. Additionally, the convenience and accessibility of a wearable device could enhance patient compliance and provide more comprehensive data for healthcare providers.

What evidence suggests that this head-mounted device is effective for visual field testing in glaucoma?

Research has shown that head-mounted devices for testing vision can effectively detect vision problems in people with glaucoma. Studies have found these devices to be as reliable as traditional methods like the Humphrey Visual Field Analyzer. One study found that the new device takes less time and makes fewer mistakes in some areas. Another study noted that patients often continue using virtual reality devices for testing, suggesting ease of use. However, some research suggests the device might not work as well for detecting early-stage glaucoma. Overall, the head-mounted device appears to be a promising tool for monitoring glaucoma. Participants in this trial will perform visual field testing with both the Humphrey Visual Field Analyzer and the custom head-mounted device to evaluate its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Brennan Eadie, MD, PhD

Principal Investigator

Nova Scotia Healthy Authority

Are You a Good Fit for This Trial?

This trial is for individuals who can consent and have had a visual field test indicating normal or varying degrees of glaucomatous damage. It excludes those with anxiety disorders, severe vertigo, certain past eye surgeries (except cataract surgery), pregnancy, seizure disorders, extreme refractive errors, inability to make informed decisions, significant eye opacity, cardiac pacemakers or similar devices.

Inclusion Criteria

Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage

I understand the study and agree to participate.

Exclusion Criteria

Cardiac pacemaker or other implantable devices

Significant media opacity

Anxiety disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing

Participants perform visual field testing with both the Humphrey Visual Field Analyzer and the custom head-mounted device, followed by a questionnaire on comfort and satisfaction.

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for any delayed responses or feedback after the testing phase.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visual Field Testing

Trial Overview The study tests a new head-mounted device for visual field testing against the standard Humphrey Visual Field Analyzer in patients with different stages of glaucoma. Each participant will use both devices over five weekly visits and complete questionnaires on comfort and satisfaction.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.

Who Is Running the Clinical Trial?

Brennan Eadie

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11926061/

Virtual Reality Visual Field Testing in Glaucoma: Benefits ... VRVFT showed comparable reliability and efficacy to SAP in detecting glaucomatous visual field defects. Benefits of VRVFT included improved ...

2. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00175-1/fulltext

Retention and Compliance over a 2-year Period Purpose. To evaluate long-term retention, compliance, and performance of glaucoma patients using a virtual reality portable perimeter to monitor ...

3. glaucomatoday.com glaucomatoday.com/articles/2020-nov-dec/a-new-era-in-visual-field-testing

A New Era in Visual Field Testing The VFE test took an average of 3 minutes, 18 seconds to complete, and it had a higher false-positive rate than the HFA, probably because locations that were ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/opo.13229

Comparing a head‐mounted virtual reality perimeter and ... The VF test was shorter (by 76 s) and had lower fixation losses (by 0.08) and false-positive rate (by 0.01) compared to the HFA (all p < 0.0001) ...

5. mdpi.com mdpi.com/2411-5150/9/4/80

Evaluating the Clinical Validity of Commercially Available ... These findings suggest that while VisuALL performs well in certain adult populations with glaucoma, its validity may be limited in early-state disease and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009299/

Virtual reality headsets for perimetry testing: a systematic review Four points in the test had agreement below 85%, indicating that Glaucoma Easy Screener may not be as accurate as Octopus GST in detecting visual field defects.

7. journals.lww.com journals.lww.com/tnoa/fulltext/2024/07000/exploring_head_mounted_virtual_visual_fields_for.5.aspx

Exploring Head-Mounted Virtual Visual Fields for ... This review examines the features, accuracy, and reliability of commercially available head-mounted VR perimeters and compares them with the gold standard, the ...

8. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00070-8/fulltext

Esterman Visual Field Testing Using a Virtual Reality ... While results on the 2 devices differed, the pilot study showed that glaucoma patients may successfully complete EVF testing with a virtual ...

9. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05030714

Evaluation of a Novel Head-Mounted Device for Glaucoma ... This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head- ...