Glaucoma
Conditions
Keywords
Glaucoma
Brief 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSmartSystem VR Headset perimeter
Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.
Sponsors
Andrew Pouw, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Field Performance Metric #1 - Mean Deviation | 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. | 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. |
| Visual Field Performance Metric #2 - Pattern Standard Deviation | 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. | 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. |
| Visual Field Performance Metric #3 - Test Duration | 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 metric indicates how long each visual field test took to complete per eye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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]? | 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. | This question will be rated using a Likert scale. Response options will include very anxious/concerned, anxious/concerned, neutral, relaxed, and very relaxed. |
| 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? | 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. | Response options will include yes, no, and maybe. |
| Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | 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. | This question will be rated using a Likert scale. Response options will include very uncomfortable, uncomfortable, neutral, comfortable, and very comfortable. |
| Visual Field User Experience Question #7 - Which Visual Field Test Would You Rather Use at Follow-up Visits? | 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. | Response options will include Humprey Field Analyzer, Smart System Virtual Reality Headset, and unsure. |
| Visual Field User Experience Question #6 - If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it? | 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. | Response options will include yes, no, and maybe. |
| 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]? | 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. | This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy. |
| 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]? | 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. | This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy. |
Countries
United States
Participant flow
Recruitment details
52 subjects (98 eyes) were recruited at the University of Iowa Hospitals and Clinics Department of Ophthalmology and Visual Sciences Glaucoma Service between January 2023 and June 2023.
Pre-assignment details
Subjects recruited for the present study completed two visual field tests, one with the Smart System VR headset and one with the Humphrey Field Analyzer III. The order of testing was randomized upon study enrollment using a random number generator.
Participants by arm
| Arm | Count |
|---|---|
| 2-Arm Crossover Study Design 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.
SmartSystem VR Headset perimeter: Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter. | 52 |
| 2-Arm Crossover Study Design 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.
SmartSystem VR Headset perimeter: Patients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter. | 81 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 4 eyes were excluded due to neurocognitive disease interfering with testing capability. | 2 | 2 |
| Overall Study | 5 eyes were excluded due to poor reliability indices | 2 | 3 |
| Overall Study | 8 eyes were excluded due to systemic or ocular disease affecting central vision. | 3 | 5 |
Baseline characteristics
| Characteristic | 2-Arm Crossover Study Design |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 73.70 years STANDARD_DEVIATION 8.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Eye Tested Left Eye | 41 eyes |
| Eye Tested Right Eye | 40 eyes |
| Glaucoma Diagnosis Aphakic | 2 eyes |
| Glaucoma Diagnosis Chronic Angle Closure | 2 eyes |
| Glaucoma Diagnosis Mixed-Mechanism | 6 eyes |
| Glaucoma Diagnosis Normal Tension | 31 eyes |
| Glaucoma Diagnosis Primary Open Angle | 27 eyes |
| Glaucoma Diagnosis Pseudoexfoliative | 10 eyes |
| Glaucoma Diagnosis Steroid-Induced | 3 eyes |
| Glaucoma Severity Early | 25 eyes |
| Glaucoma Severity Moderate | 22 eyes |
| Glaucoma Severity Severe | 34 eyes |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 18 Participants |
| Spherical Equivalent All Eyes | -0.67 Diopters STANDARD_DEVIATION 1.9 |
| Spherical Equivalent Left Eye | -0.63 Diopters STANDARD_DEVIATION 1.85 |
| Spherical Equivalent Right Eye | -0.72 Diopters STANDARD_DEVIATION 1.98 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 31 |
| other Total, other adverse events | 0 / 21 | 0 / 31 |
| serious Total, serious adverse events | 0 / 21 | 0 / 31 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Visual Field Performance Metric #1 - Mean Deviation | SSVR MD | -7.17 decibels | Standard Deviation 6.36 |
| Single Arm | Visual Field Performance Metric #1 - Mean Deviation | HFA MD | -6.88 decibels | Standard Deviation 4.51 |
Comparison: Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.p-value: 0.297t-test, 2 sided
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Visual Field Performance Metric #2 - Pattern Standard Deviation | SSVR PSD | 4.26 decibels | Standard Deviation 2.37 |
| Single Arm | Visual Field Performance Metric #2 - Pattern Standard Deviation | HFA PSD | 6.38 decibels | Standard Deviation 4.51 |
Comparison: Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.p-value: <0.001t-test, 2 sided
Primary
Visual Field Performance Metric #3 - Test Duration
This metric indicates how long each visual field test took to complete per eye.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm | Visual Field Performance Metric #3 - Test Duration | SSVR Test Duration | 323.44 seconds | Standard Deviation 72.27 |
| Single Arm | Visual Field Performance Metric #3 - Test Duration | HFA Test Duration | 372.20 seconds | Standard Deviation 61.44 |
Comparison: Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.p-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | SSVR Very Uncomfortable | 0 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | SSVR Uncomfortable | 3 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | SSVR Neutral | 7 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | SSVR Comfortable | 27 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | SSVR Very Comfortable | 15 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | HFA Very Uncomfortable | 2 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | HFA Uncomfortable | 22 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | HFA Neutral | 17 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | HFA Comfortable | 7 participants |
| Single Arm | Visual Field User Experience Question #1 - How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]? | HFA Very Comfortable | 4 participants |
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]?
This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | 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]? | SSVR Very Hard | 0 participants |
| Single Arm | 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]? | SSVR Hard | 0 participants |
| Single Arm | 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]? | SSVR Neutral | 2 participants |
| Single Arm | 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]? | SSVR Easy | 18 participants |
| Single Arm | 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]? | SSVR Very Easy | 32 participants |
| Single Arm | 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]? | HFA Very Hard | 0 participants |
| Single Arm | 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]? | HFA Hard | 2 participants |
| Single Arm | 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]? | HFA Neutral | 9 participants |
| Single Arm | 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]? | HFA Easy | 19 participants |
| Single Arm | 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]? | HFA Very Easy | 22 participants |
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]?
This question will be rated using a Likert scale. Response options will include very hard, hard, neutral, easy, and very easy.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | 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]? | SSVR Very Hard | 0 participants |
| Single Arm | 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]? | SSVR Hard | 0 participants |
| Single Arm | 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]? | SSVR Neutral | 5 participants |
| Single Arm | 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]? | SSVR Easy | 19 participants |
| Single Arm | 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]? | SSVR Very Easy | 28 participants |
| Single Arm | 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]? | HFA Very Hard | 5 participants |
| Single Arm | 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]? | HFA Hard | 19 participants |
| Single Arm | 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]? | HFA Neutral | 15 participants |
| Single Arm | 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]? | HFA Easy | 11 participants |
| Single Arm | 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]? | HFA Very Easy | 2 participants |
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]?
This question will be rated using a Likert scale. Response options will include very anxious/concerned, anxious/concerned, neutral, relaxed, and very relaxed.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm | 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]? | SSVR Very Anxious | 0 participants |
| Single Arm | 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]? | SSVR Anxious | 6 participants |
| Single Arm | 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]? | SSVR Neutral | 12 participants |
| Single Arm | 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]? | SSVR Relaxed | 24 participants |
| Single Arm | 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]? | SSVR Very Relaxed | 10 participants |
| Single Arm | 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]? | HFA Very Anxious | 1 participants |
| Single Arm | 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]? | HFA Anxious | 21 participants |
| Single Arm | 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]? | HFA Neutral | 13 participants |
| Single Arm | 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]? | HFA Relaxed | 13 participants |
| Single Arm | 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]? | HFA Very Relaxed | 4 participants |
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?
Response options will include yes, no, and maybe.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | 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? | Yes | 40 Participants |
| Single Arm | 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? | No | 3 Participants |
| Single Arm | 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? | Maybe | 9 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Visual Field User Experience Question #6 - If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it? | Yes | 36 Participants |
| Single Arm | Visual Field User Experience Question #6 - If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it? | No | 5 Participants |
| Single Arm | Visual Field User Experience Question #6 - If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it? | Maybe | 11 Participants |
Secondary
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Visual Field User Experience Question #7 - Which Visual Field Test Would You Rather Use at Follow-up Visits? | SSVR | 46 Participants |
| Single Arm | Visual Field User Experience Question #7 - Which Visual Field Test Would You Rather Use at Follow-up Visits? | HFA | 2 Participants |
| Single Arm | Visual Field User Experience Question #7 - Which Visual Field Test Would You Rather Use at Follow-up Visits? | Unsure | 4 Participants |