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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

Study Summary

This trial compares a new device for testing peripheral vision to the current standard device and surveys patients on their experience to determine which has better performance and user experience.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Field Performance Metric #1 - Mean Deviation
Visual Field Performance Metric #2 - Pattern Standard Deviation
Visual Field Performance Metric #3 - Total Deviation
+5 more
Secondary outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
All patients will be in a single arm: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SmartSystem VR Headset perimeter
2023
N/A
~60

Find a Location

Who is running the clinical trial?

Andrew Pouw, MDLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Glaucoma
50 Patients Enrolled for Glaucoma

Media Library

Single arm Clinical Trial Eligibility Overview. Trial Name: NCT05674890 — N/A
Glaucoma Research Study Groups: Single arm
Glaucoma Clinical Trial 2023: Single arm Highlights & Side Effects. Trial Name: NCT05674890 — N/A
Single arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05674890 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this clinical trial encompass those aged 25 and over?

"According to the requirements stated in this study, participants must be between 18 and 100 years old."

Answered by AI

Am I eligible to take part in this medicinal research?

"This research is seeking 50 participants that are 18 to 100 years old and suffering from a glaucoma diagnosis between mild, moderate, or severe."

Answered by AI

Is the enrollment period still available for this experiment?

"Affirmative. The information posted on clinicaltrials.gov suggests that this research is currently recruiting for participants, with the initial posting having been made on March 1st 2023 and an update occurring April 1st of the same year. 50 volunteers are needed from a single medical facility."

Answered by AI

How many participants are involved in this investigation?

"Affirmative. According to the information made available on clinicaltrials.gov, this experiment is actively recruiting participants as of April 1st 2023 and was initially posted on March 3rd 2023. There are 50 openings for patients at one specific medical centre."

Answered by AI

What outcomes are researchers aiming to attain with this medical experiment?

"This trial's foremost end point is the False Negative Rate of its Visual Field Reliability Metric #2. Secondary objectives consist of three User Experience questions, each assessed with a Likert scale - ranging from "very hard" to "very easy", "very anxious/concerned" to "very relaxed". The estimated time for completion of visual field testing lies between 5-15 minutes and all tests should be administered within 1-2 hours on the same day."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter
Andrew Pouw, MD 2023. "SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674890.
~23 spots leftby Apr 2025
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