Trial Outcomes & Findings for SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter (NCT NCT05674890)
NCT ID: NCT05674890
Last Updated: 2024-08-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
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.
Results posted on
2024-08-09
Participant Flow
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.
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.
Unit of analysis: 98 eyes were tested overall.
Participant milestones
| Measure |
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 using a random number generator. Group A includes patients who test using the HFA first, followed by a 15 minute rest period, then test with the SSVR.
SmartSystem VR Headset perimeter: 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 using a random number generator. Group B includes patients who test using the SSVR first, followed by a 15 minute rest period, then test with the HFA.
|
|---|---|---|
|
Overall Study
STARTED
|
40 40
|
58 58
|
|
Overall Study
COMPLETED
|
33 33
|
48 48
|
|
Overall Study
NOT COMPLETED
|
7 7
|
10 10
|
Reasons for withdrawal
| Measure |
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 using a random number generator. Group A includes patients who test using the HFA first, followed by a 15 minute rest period, then test with the SSVR.
SmartSystem VR Headset perimeter: 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 using a random number generator. Group B includes patients who test using the SSVR first, followed by a 15 minute rest period, then test with the HFA.
|
|---|---|---|
|
Overall Study
5 eyes were excluded due to poor reliability indices
|
2
|
3
|
|
Overall Study
4 eyes were excluded due to neurocognitive disease interfering with testing capability.
|
2
|
2
|
|
Overall Study
8 eyes were excluded due to systemic or ocular disease affecting central vision.
|
3
|
5
|
Baseline Characteristics
We included 40 right eyes and 41 left eyes in our analysis. The total number of eyes was 81 from 45 subjects (both the right and left eye were excluded in 7/52 subjects).
Baseline characteristics by cohort
| Measure |
2-Arm Crossover Study Design
n=81 Eyes
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=52 Participants
|
|
Age, Continuous
|
73.70 years
STANDARD_DEVIATION 8.27 • n=52 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
|
Glaucoma Diagnosis
Normal Tension
|
31 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Primary Open Angle
|
27 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Pseudoexfoliative
|
10 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Mixed-Mechanism
|
6 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Steroid-Induced
|
3 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Chronic Angle Closure
|
2 eyes
n=81 Eyes
|
|
Glaucoma Diagnosis
Aphakic
|
2 eyes
n=81 Eyes
|
|
Glaucoma Severity
Early
|
25 eyes
n=81 Eyes
|
|
Glaucoma Severity
Moderate
|
22 eyes
n=81 Eyes
|
|
Glaucoma Severity
Severe
|
34 eyes
n=81 Eyes
|
|
Spherical Equivalent
Right Eye
|
-0.72 Diopters
STANDARD_DEVIATION 1.98 • n=40 Eyes • We included 40 right eyes and 41 left eyes in our analysis. The total number of eyes was 81 from 45 subjects (both the right and left eye were excluded in 7/52 subjects).
|
|
Spherical Equivalent
Left Eye
|
-0.63 Diopters
STANDARD_DEVIATION 1.85 • n=41 Eyes • We included 40 right eyes and 41 left eyes in our analysis. The total number of eyes was 81 from 45 subjects (both the right and left eye were excluded in 7/52 subjects).
|
|
Spherical Equivalent
All Eyes
|
-0.67 Diopters
STANDARD_DEVIATION 1.90 • n=81 Eyes • We included 40 right eyes and 41 left eyes in our analysis. The total number of eyes was 81 from 45 subjects (both the right and left eye were excluded in 7/52 subjects).
|
|
Eye Tested
Right Eye
|
40 eyes
n=81 Eyes
|
|
Eye Tested
Left Eye
|
41 eyes
n=81 Eyes
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single Arm
n=81 Eyes
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.
|
|---|---|
|
Visual Field Performance Metric #1 - Mean Deviation
SSVR MD
|
-7.17 decibels
Standard Deviation 6.36
|
|
Visual Field Performance Metric #1 - Mean Deviation
HFA MD
|
-6.88 decibels
Standard Deviation 4.51
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single Arm
n=81 Eyes
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.
|
|---|---|
|
Visual Field Performance Metric #2 - Pattern Standard Deviation
HFA PSD
|
6.38 decibels
Standard Deviation 4.51
|
|
Visual Field Performance Metric #2 - Pattern Standard Deviation
SSVR PSD
|
4.26 decibels
Standard Deviation 2.37
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Single Arm
n=81 eyes
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.
|
|---|---|
|
Visual Field Performance Metric #3 - Test Duration
SSVR Test Duration
|
323.44 seconds
Standard Deviation 72.27
|
|
Visual Field Performance Metric #3 - Test Duration
HFA Test Duration
|
372.20 seconds
Standard Deviation 61.44
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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".
Outcome measures
| Measure |
Single Arm
n=52 Participants
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.
|
|---|---|
|
Visual Field User Experience Question #7 - "Which Visual Field Test Would You Rather Use at Follow-up Visits?"
SSVR
|
46 Participants
|
|
Visual Field User Experience Question #7 - "Which Visual Field Test Would You Rather Use at Follow-up Visits?"
HFA
|
2 Participants
|
|
Visual Field User Experience Question #7 - "Which Visual Field Test Would You Rather Use at Follow-up Visits?"
Unsure
|
4 Participants
|
Adverse Events
Group A: HFA Followed by SSVR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: SSVR Followed by HFA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Pouw
University of Iowa Hospitals and Clinics Department of Ophthalmology and Visual Sciences
Phone: 3193562928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place