SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare a new device for testing peripheral vision (the SmartSystem virtual reality headset) to the currently most commonly used standard testing device (the Humphrey HFA-III). The main questions this clinical trials aims to answer are: How comparable in performance, accuracy, and patient comfort the SmartSystem VR headset is to the Humphrey HFA-III, and Surveying patients about the perceived ease of use and patient experience with the SmartSystem VR headset, compared to the Humphrey HFA-III. Participants will be asked to use the SmartSystem VR headset to take an additional visual field test (which takes between 10 to 15 minutes to do) and to take a brief survey about their experience. This will occur on regularly scheduled clinic visits and done in addition to the standard tests and examinations scheduled for that day. Researchers will compare the patients' test results and survey responses for both the SmartSystem VR headset and the Humphrey HFA-III to see which has more favorable performance, reliability, duration of testing and user experience.

Detailed Description
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The purpose of this prospective study is to compare the novel SmartSystem VR Headset (M&S Technologies, Niles, IL) to the Humphrey Field Analyzer (Carl Zeiss Meditec Inc., Dublin, CA). Use of the Humphrey Field Analyzer is part of routine clinical care of glaucoma and would be completed regardless of study participation. The proposed study will be conducted at the University of Iowa Hospitals and Clinics. We estimate 50 subjects will be recruited to participate in the study. Data collected will not include patient identifiers. The research will involve prospective collection of visual field tests. Patients with suspected, mild, moderate, or severe glaucoma will be included. Clinical data including age, gender, ethnicity, visual acuity, intraocular pressure, severity of disease, Humphrey HFA-III performance, SmartSystem VR Headset performance, and satisfaction survey will be recorded. Subjects will undergo regular clinical examination, including measurement of visual acuity, intraocular pressure, slit lamp examination by their physician, and visual field testing as indicated. When it comes time to perform visual field testing, subjects will be randomized to complete either the SmartSystem VR Headset visual field test first followed by the Humphrey Field Analyzer visual field test, or vice versa. Visual field tests will be separated by a rest period of 10 to 15 minutes to minimize testing fatigue. The SmartSystem VR Headset is fit to subjects' head using an adjustable head strap. Once the headset it fit to the subject, a research assistant will send a test to the headset from a bluetooth-connected electronic device using M&S Technologies' secured application platform. Subjects will follow prompts from the SmartSystem VR Headset to complete their visual field test, responding using a handheld trigger device. Testing is expected to take approximately 5-15 minutes, depending on the subjects' severity of visual field loss. Following visual field testing using both the SmartySystem VR Headset and Humphrey Field Analyzer, subjects will complete a 13-question satisfaction survey. The total expected time commitment of this study is a 1 to 2 hour visit. M&S Technologies is the developer of the SmartSystem VR Headset visual field test. As the developers, M&S Technologies maintains a secure, encrypted, HIPAA-compliant database of SmartSystem VR Headset users. This database includes patient profiles containing unique subject IDs (de-identified), birth year (but not specific date), and visual field testing results. Outside of this testing information, M&S Technologies does not have access to any additional patient information.

Official Title
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Comparison of a Novel Head-Mounted Perimeter Versus the Humphrey Field Analyzer

Conditions
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Glaucoma

Intervention / Treatment
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* Diagnostic Test: SmartSystem VR Headset perimeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18-100 years of age with suspected, mild, moderate, or severe glaucoma Exclusion Criteria: Non-English speakers, patients with systemic or ocular disease affecting central vision, best corrected visual acuity less than 20/80, neurocognitive or psychiatric disorders that would confound visual field testing, those with physical inability to perform testing, and astigmatism with absolute values greater than 2.00 diopters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>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. | Diagnostic Test: SmartSystem VR Headset perimeter<br>* Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Field Reliability Metric #1 - False Positive Rate | In perimetry (visual field testing), a false positive error occurs when a subject/patient records a response when no stimulus is presented. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Reliability Metric #2 - False Negative Rate | In perimetry (visual field testing), a false negative error occurs when a subject/patient fails to record a response to a stimulus that is brighter than one they had previously responded to in the same visual location. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Reliability Metric #3 - Fixation Loss Rate | In perimetry (visual field testing), a fixation loss occurs when a subject/patient records a response to a stimulus presented in the physiologic blind spot. If the patient responds, it indicates their gaze is not fixed straight ahead. This is one metric by which the reliability of a visual field test is measured. The measurement is reported as a percentage. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Performance Metric #1 - Mean Deviation | Mean deviation indicates how much, on average, an entire visual field deviates from the age-normal value. It is the center-weighted average of the decibel deviations at each point tested in the visual field test. The measurement is reported in decibels. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Performance Metric #2 - Pattern Standard Deviation | Pattern standard deviation reflects irregularities in a visual field, such as those caused by localized defects. This metric shows sensitivity losses after adjusting for generalized depression or elevation in the overall hill of vision (e.g. cataracts). The measurement is reported in decibels. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Performance Metric #3 - Total Deviation | Total deviation probability plots identify test locations that are outside normal limits. Threshold sensitivity levels are compared to age-corrected normal values at each test location to produce a total deviation map. Each measurement is reported in decibels. | These measurements will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Performance Metric #4 - Foveal Threshold | Foveal threshold is the minimum amount of luminance increment on a uniform background that can be detected by a subject/patient at the center of fixation. The measurement is reported in decibels. | This measurement will automatically be reported upon conclusion of each visual field test. Visual field testing is estimated to take 5-15 minutes for each visual field test. All testing will occur on the same day within a 1-2 hour period. | 
| Visual Field Performance Metric #5 - Mean Threshold per Garway-Heath Sector | This metric indicates how much, on average, the threshold values in each Garway-Heath sector (a commonly used mapping method with established precedent in this area of research) deviate from the age-normal value. It is the average of the decibel deviations at each point tested in the sector. The measurement is reported in decibels. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Field User Experience Question #1 - How would you rate the comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | This question will be rated using a Likert scale. Response options will include very uncomfortable, uncomfortable, neutral, comfortable, and very comfortable. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| 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]? | This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| 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]? | This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| Visual Field User Experience Question #4 - How much anxiety or concern did you have about your test performance while using the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | This question will be rated using a Likert scale. Response options will include very anxious/concerned, anxious/concerned, neutral, relaxed, and very relaxed. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| Visual Field User Experience Question #5 - Given instruction and training, would you feel comfortable performing visual field testing by yourself at home using the Smart System Virtual Reality Headset? | Response options will include yes, no, and maybe. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| Visual Field User Experience Question #6 - If the Smart System Virtual Reality Headset were available for home use, would you use it? | Response options will include yes, no, and maybe. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 
| Visual Field User Experience Question #7 - Which visual field test would you rather use at follow-up visits? | Response options will include Humprey Field Analyzer, Smart System Virtual Reality Headset, and unsure. | Subjects will respond to an approximately 5-10 minute survey upon completion of both visual field tests. The survey will be administered the same day as visual field testing at the conclusion of the estimated 1-2 hour period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma