GlaucomaNCT05674890

SmartSystem Virtual Reality Headset Perimeter Versus Humphrey HFA-III Perimeter

A study testing SmartSystem VR Headset perimeter in people with Glaucoma, run by Andrew Pouw, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Glaucoma
What is being tested?: SmartSystem VR Headset perimeter
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2023to 1 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients between 18-100 years of age with suspected, mild, moderate, or severe glaucoma

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Glaucoma
Being tested: SmartSystem VR Headset perimeter
Keywords: Glaucoma
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05674890
Study group	Role	What they receive
Group A: HFA followed by SSVR	Other	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. Receives: Diagnostic Test: SmartSystem VR Headset perimeter
Group B: SSVR followed by HFA	Other	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. Receives: Diagnostic Test: SmartSystem VR Headset perimeter

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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 - Test Duration
This metric indicates how long each visual field test took to complete per eye.
Measured: 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 outcomes (7)

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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 20231 Jun 2023

First posted9 Jan 2023
Study start3 Jan 2023
Primary completion1 Jun 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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.
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05674890
Sponsor's protocol ID: 202206347
Status last verified: Aug 2024
First submitted: 3 Jan 2023
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
PubMed 8695555
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940
Beck RW, Bergstrom TJ, Lichter PR. A clinical comparison of visual field testing with a new automated perimeter, the Humphrey Field Analyzer, and the Goldmann perimeter. Ophthalmology. 1985 Jan;92(1):77-82. doi: 10.1016/s0161-6420(85)34065-4.
PubMed 3974997
Hollander DA, Volpe NJ, Moster ML, Liu GT, Balcer LJ, Judy KD, Galetta SL. Use of a portable head mounted perimetry system to assess bedside visual fields. Br J Ophthalmol. 2000 Oct;84(10):1185-90. doi: 10.1136/bjo.84.10.1185.
PubMed 11004108
Mees L, Upadhyaya S, Kumar P, Kotawala S, Haran S, Rajasekar S, Friedman DS, Venkatesh R. Validation of a Head-mounted Virtual Reality Visual Field Screening Device. J Glaucoma. 2020 Feb;29(2):86-91. doi: 10.1097/IJG.0000000000001415.
PubMed 31790067
Nakai Y, Bessho K, Shono Y, Taoka K, Nakai Y. Comparison of imo and Humphrey field analyzer perimeters in glaucomatous eyes. Int J Ophthalmol. 2021 Dec 18;14(12):1882-1887. doi: 10.18240/ijo.2021.12.11. eCollection 2021.
PubMed 34926203

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a Novel Head-Mounted Perimeter Versus the Humphrey Field Analyzer
ClinicalTrials.gov ID: NCT05674890
Acronym / sponsor ID: 202206347
Conditions: Glaucoma
Keywords: Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Andrew Pouw, MDUniversity, hospital or other
Study start: 3 Jan 2023 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 9 Jan 2023 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group A: HFA followed by SSVR	Other	Diagnostic Test: SmartSystem VR Headset perimeterPatients 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 B: SSVR followed by HFA	Other	Diagnostic Test: SmartSystem VR Headset perimeterPatients 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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients between 18-100 years of age with suspected, mild, moderate, or severe glaucoma

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SmartSystem VR Headset perimeterPatients will undergo visual field testing with the head-mounted SmartSystem VR Headset perimeter.	Diagnostic test	Group A: HFA followed by SSVR, Group B: SSVR followed by HFA

Primary outcome

Visual Field Performance Metric #1 - Mean Deviation
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.
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
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.
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
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.
This metric indicates how long each visual field test took to complete per eye.

7 secondary outcomes

Visual Field User Experience Question #1 - "How Would You Rate the Comfort of the [Humphrey Field Analyzer/Smart System Virtual Reality Headset]?"
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.
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]?"
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.
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]?"
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.
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]?"
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.
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?"
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.
Visual Field User Experience Question #6 - "If the Smart System Virtual Reality Headset Were Available for Home Use, Would You Use it?"
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.
Visual Field User Experience Question #7 - "Which Visual Field Test Would You Rather Use at Follow-up Visits?"
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.

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: HFA Followed by SSVR	40	33
Group B: SSVR Followed by HFA	58	48

Primary outcome: Visual Field Performance Metric #1 - Mean Deviation

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.. Mean (Standard Deviation). Unit: decibels

Measure	Single Arm n = 45
SSVR MD	-7.17 (6.36)
HFA MD	-6.88 (4.51)

Single Arm: Mean Difference (Net): -0.29, p = 0.297, t-test, 2 sided

Primary outcome: Visual Field Performance Metric #2 - Pattern Standard Deviation

Measure	Single Arm n = 45
SSVR PSD	4.26 (2.37)
HFA PSD	6.38 (4.51)

Single Arm: Mean Difference (Net): -2.11, p <0.001, t-test, 2 sided

Primary outcome: Visual Field Performance Metric #3 - Test Duration

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.. Mean (Standard Deviation). Unit: seconds

Measure	Single Arm n = 45
SSVR Test Duration	323.44 (72.27)
HFA Test Duration	372.20 (61.44)

Single Arm: Mean Difference (Net): -48.75, p <0.001, t-test, 2 sided

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the duration of the study, from December 2022 to June 2023. Individual participants were monitored for the duration of their clinical appointments, approximately 1-2 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: HFA Followed by SSVR	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Group B: SSVR Followed by HFA	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8695555Quigley HA. Number of people with glaucoma worldwide. Br J Ophthalmol. 1996 May;80(5):389-93. doi: 10.1136/bjo.80.5.389.
Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
Background: PubMed 3974997Beck RW, Bergstrom TJ, Lichter PR. A clinical comparison of visual field testing with a new automated perimeter, the Humphrey Field Analyzer, and the Goldmann perimeter. Ophthalmology. 1985 Jan;92(1):77-82. doi: 10.1016/s0161-6420(85)34065-4.
Background: PubMed 11004108Hollander DA, Volpe NJ, Moster ML, Liu GT, Balcer LJ, Judy KD, Galetta SL. Use of a portable head mounted perimetry system to assess bedside visual fields. Br J Ophthalmol. 2000 Oct;84(10):1185-90. doi: 10.1136/bjo.84.10.1185.
Background: PubMed 31790067Mees L, Upadhyaya S, Kumar P, Kotawala S, Haran S, Rajasekar S, Friedman DS, Venkatesh R. Validation of a Head-mounted Virtual Reality Visual Field Screening Device. J Glaucoma. 2020 Feb;29(2):86-91. doi: 10.1097/IJG.0000000000001415.
Background: PubMed 34926203Nakai Y, Bessho K, Shono Y, Taoka K, Nakai Y. Comparison of imo and Humphrey field analyzer perimeters in glaucomatous eyes. Int J Ophthalmol. 2021 Dec 18;14(12):1882-1887. doi: 10.18240/ijo.2021.12.11. eCollection 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Pouw, MD principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SmartSystem VR Headset perimeter in people with Glaucoma, run by Andrew Pouw, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Field Performance Metric #1 - Mean Deviation (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674890, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.