N/A
N=98
SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT05674890 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Visual Field Performance Metric #1 - Mean Deviation — -7.17; -6.88 decibels — p=0.297
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmartSystem VR Headset perimeter (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrew Pouw, MD
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Field Performance Metric #1 - Mean Deviation |
-7.17; -6.88 | 0.297 |
| PRIMARY Visual Field Performance Metric #2 - Pattern Standard Deviation |
4.26; 6.38 | <0.001 sig |
| PRIMARY Visual Field Performance Metric #3 - Test Duration |
323.44; 372.20 | <0.001 sig |
| SECONDARY Visual Field User Experience Question #1 - "How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?" |
0; 3; 7; 27; 15; 2 | — |
| SECONDARY 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]?" |
0; 0; 2; 18; 32; 0 | — |
| SECONDARY 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]?" |
0; 0; 5; 19; 28; 5 | — |
| SECONDARY 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]?" |
0; 6; 12; 24; 10; 1 | — |
| SECONDARY 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?" |
40; 3; 9 | — |
| SECONDARY Visual Field User Experience Question #6 - "If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it?" |
36; 5; 11 | — |
| SECONDARY Visual Field User Experience Question #7 - "Which Visual Field Test Would You Rather Use at Follow-up Visits?" |
46; 2; 4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05674890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.