What side effects are associated with this type of intervention?

Common treatments for glaucoma include medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. Prostaglandin analogs can cause eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to systemic side effects like bradycardia and respiratory issues. Alpha agonists can cause dry mouth, fatigue, and allergic reactions. Carbonic anhydrase inhibitors might result in a metallic taste, frequent urination, and tingling in the fingers and toes. While the SmartSystem VR headset trial focuses on peripheral vision testing, it does not directly relate to these treatments but aims to improve the diagnostic process for glaucoma.

What prior FDA approvals exist?

FDA-approved treatments for glaucoma primarily include medications such as prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol), alpha agonists (e.g., brimonidine), and carbonic anhydrase inhibitors (e.g., dorzolamide). These treatments aim to reduce intraocular pressure to prevent damage to the optic nerve. While the SmartSystem VR headset trial focuses on peripheral vision testing using virtual reality technology, there is no specific mention of VR technology being FDA-approved for glaucoma treatment. However, advancements in diagnostic tools like VR headsets could potentially enhance the monitoring and management of glaucoma by providing more accurate and patient-friendly methods for assessing peripheral vision loss.

What other types of research exist?

Promising alternatives to the SmartSystem VR headset for peripheral vision testing in glaucoma patients include: 1) Humphrey Field Analyzer (HFA) with advanced software updates for improved accuracy and patient comfort, 2) Octopus Perimeter, which offers comprehensive visual field analysis with user-friendly interfaces, and 3) Compass Fundus Perimeter, which combines visual field testing with retinal imaging for more detailed assessments. These devices are known for their reliability and are continuously being updated with new features to enhance testing efficiency and patient experience.

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Virtual Reality Visual Field Testing for Glaucoma

N/A

Waitlist Available

Research Sponsored by Andrew Pouw, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up these measurements will be derived during data analysis following study completion. the exact study duration is unclear; however, we aim to recruit enough patients to analyze 80 eyes worth of data. we estimate this will take 3-6 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new VR headset for vision testing to the current standard device. It focuses on glaucoma patients who need frequent vision tests. The headset works by showing visual cues and recording patient responses to measure peripheral vision.

Who is the study for?

This trial is for English-speaking individuals aged 18-100 with suspected or confirmed glaucoma of any severity. It's not suitable for those with severe astigmatism, poor vision (worse than 20/80), physical limitations preventing testing, diseases affecting central vision, or neurocognitive/psychiatric conditions that could affect the results.

What is being tested?

The study is comparing a new virtual reality headset device called SmartSystem to the standard Humphrey HFA-III in measuring peripheral vision. Participants will use both devices during regular clinic visits and answer a survey about their experience to assess performance and comfort.

What are the potential side effects?

There are no direct side effects from participating in this trial as it involves non-invasive visual field testing using different types of equipment. However, some participants may experience discomfort or fatigue from wearing the VR headset.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ these measurements will be derived during data analysis following study completion. the exact study duration is unclear; however, we aim to recruit enough patients to analyze 80 eyes worth of data. we estimate this will take 3-6 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~these measurements will be derived during data analysis following study completion. the exact study duration is unclear; however, we aim to recruit enough patients to analyze 80 eyes worth of data. we estimate this will take 3-6 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and these measurements will be derived during data analysis following study completion. the exact study duration is unclear; however, we aim to recruit enough patients to analyze 80 eyes worth of data. we estimate this will take 3-6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Field Performance Metric #1 - Mean Deviation

Visual Field Performance Metric #2 - Pattern Standard Deviation

Visual Field Performance Metric #3 - Test Duration

Secondary study objectives

Visual Field User Experience Question #1 - "How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

Visual Field User Experience Question #2 - "How Hard or Easy Was it to Understand the Instructions Given to You for How to do the Visual Field Test Using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

Visual Field User Experience Question #3 - "How Hard or Easy Was it to Use and/or Perform the Visual Field Test Using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: SSVR followed by HFAExperimental Treatment1 Intervention

Patients will have one or both eyes (dependent on inclusion/exclusion criteria) tested with both the Humphrey HFA-III perimeter and the SmartSystem VR headset on the same clinic visit, spaced roughly 10-15 minutes apart. The sequence in which each patient undertakes the two tests will be randomized. Group B includes participants who tested using the SSVR, followed by a 15 minute rest period, then tested with the HFA.

Group II: Group A: HFA followed by SSVRExperimental Treatment1 Intervention

Patients will have one or both eyes (dependent on inclusion/exclusion criteria) tested with both the Humphrey HFA-III perimeter and the SmartSystem VR headset on the same clinic visit, spaced roughly 10-15 minutes apart. The sequence in which each patient undertakes the two tests will be randomized. Group A includes participants who tested using the HFA, followed by a 15 minute rest period, then tested with the SSVR.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SmartSystem VR Headset perimeter

2023

N/A

~60

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Glaucoma work by either decreasing the production of aqueous humor or increasing its outflow to manage intraocular pressure (IOP). Prostaglandin analogs increase the outflow of aqueous humor, beta-blockers reduce its production, alpha agonists both decrease production and increase outflow, carbonic anhydrase inhibitors lower production, and Rho kinase inhibitors enhance outflow through the trabecular meshwork. Effective IOP management is crucial for Glaucoma patients to prevent optic nerve damage and preserve vision, including peripheral vision, which is often tested using technologies like the SmartSystem VR headset.