SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2023-06-01

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:

1. How comparable in performance, accuracy, and patient comfort the SmartSystem VR headset is to the Humphrey HFA-III, and
2. 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.

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The described study was a validation study comparing a novel testing device to the current clinical standard. The order of testing was randomized, so the design is that of a crossover study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group A: HFA followed by SSVR

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.

Group Type OTHER

SmartSystem VR Headset perimeter

Intervention Type DIAGNOSTIC_TEST

Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.

Group B: SSVR followed by HFA

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 Type OTHER

SmartSystem VR Headset perimeter

Intervention Type DIAGNOSTIC_TEST

Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.

Interventions

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SmartSystem VR Headset perimeter

Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No