GlaucomaNCT06549010
Perimetric Testing With Virtual Reality
A study testing Perimetric test in people with Glaucoma, run by Envision Health Technologies, Inc. at 1 site in United States.
Trial summary
Perimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Perimetric test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 25-70 years
- For normal subjects:
- Patient is free of any current or prior ophthalmic pathologies that would potentially cause visual field defects: e.g. retina pathology, glaucoma, cataracts, keratoconus
- No ocular surgery other than cataract surgery within 6 months prior to the study visit
- For glaucoma subjects:
- Patient has a diagnosis of primary open-angle glaucoma
Show all 16Show fewer
- Patient is free of any other current or prior ophthalmic pathologies that would potentially cause visual field defects.
- No other ocular surgery other than glaucoma or cataract surgery within 6 months prior to the study visit
- No IOP lower than 10 mm/Hg or higher than 30 mm/Hg
- Refractive Error:
- Sphere = up to -6.00 D to and up +3.00
- Cylinder = up to -3.00 is common
- No past refractive eye surgery
- No Multifocal or phakic (ICLs) IOL; no multifocal CLs
- One eligible eye
- Ability to sit for standard VF bowl exam. Ability to wear VR perimetry headset device.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Illinois College of Optometry / Illinois Eye Institute
Chicago, Illinois, 60616
Michael Chaglasian, OD, 312-949-7303, mchaglas@ico.edu
About this study
Official title: A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.
Perimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Visual field (VF) testing provided by the HFA is standard-of-care in glaucoma clinics and other ophthalmology and optometry practices. However, the HFA is a large device that does not allow for examination outside the clinic and can be uncomfortable for patients with limited mobility.
This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. The results of this study will potentially serve as pilot data for the design of a larger study that involves the full assessment of the VR headset and its VF test, based on various testing strategies.
Read the detailed description
Procedures:
- Ophthalmic screening: (a) Visual acuity, slit lamp exam, rebound tonometry (all subjects)
- OCT examination of the study eye with the Topcon Maestro2 Optical Coherence Tomography (OCT): (a) Standard Retinal Nerve Fiber Layer (RNFL), Optic Disc and Ganglion Cell Complex (GCC) scan patterns (i) Fundus photo is automatically obtained. (b) Abnormalities consistent with ophthalmic disease will be an exclusion for the healthy group of subjects. Reasonable and common artifacts that do not significantly impair the scan report will be accepted. (c) OCT abnormalities consistent with glaucoma are expected on the 30 glaucoma subjects.
- Once eligible, each patient will perform four (4) visual field tests: (a) once with the HFA Swedish Interactive Threshold Algorithm (SITA) Standard 24-2 pattern (i) Reliability criteria: False Positives no higher than 15% (b) three tests with the VR headset: (i) two tests with ZEST strategy (ii) one test with gamified ZEST strategy (c) Counter-balancing will be used to determine the order of (a) and (b). In particular, a study participant will either start with the HFA visual field test and then proceed to the three tests with the VR headset; or, start with the three VR tests and finish with the HFA visual field test. The sequence of the visual field tests for each study ID will be provided by the sponsor.
- Conditions
- Glaucoma
- Being tested
- Perimetric test
- Keywords
- Glaucoma, Perimetric test, virtual reality
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perimetric testDiagnostic test
This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | 30 healthy subjects Receives: Diagnostic Test: Perimetric test |
| Glaucoma subjects | Other | 30 glaucoma patients, 10 mild, 10 moderate, 10 severe Receives: Diagnostic Test: Perimetric test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field perimetry light sensitivity
Localized differential light sensitivity threshold measured in decibels (dB)
Measured: 1 day
Visual field perimetry foveal sensitivity
Foveal threshold in decibels (dB)
Measured: 1 day
Visual field perimetry test duration
Test duration measured in minutes
Measured: 1 day
Secondary outcomes (1)
Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) thickness values may be used, such as Retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness, measured in microns.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start3 Jul 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 30 healthy subjects 30 glaucoma subjects
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Envision Health Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Responsible party
- Sponsor
- Investigators
- Michael Chaglasian, OD, Principal investigator, Illinois College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549010
- Sponsor's protocol ID
- ENV1
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data and data analysis will be shared for communication of results and learning conclusions.
Publications
Montesano G, Bryan SR, Crabb DP, Fogagnolo P, Oddone F, McKendrick AM, Turpin A, Lanzetta P, Perdicchi A, Johnson CA, Garway-Heath DF, Brusini P, Rossetti LM. A Comparison between the Compass Fundus Perimeter and the Humphrey Field Analyzer. Ophthalmology. 2019 Feb;126(2):242-251. doi: 10.1016/j.ophtha.2018.08.010. Epub 2018 Aug 14.
PubMed 30114416Marin-Franch I, Turpin A, Artes PH, Chong LX, McKendrick AM, Alawa KA, Wall M. The Open Perimetry Initiative: A framework for cross-platform development for the new generation of portable perimeters. J Vis. 2022 Apr 6;22(5):1. doi: 10.1167/jov.22.5.1.
PubMed 35385053Marin-Franch I, Swanson WH. The visualFields package: a tool for analysis and visualization of visual fields. J Vis. 2013 Mar 14;13(4):10. doi: 10.1167/13.4.10.
PubMed 23492926Bradley C, Ahmed IIK, Samuelson TW, Chaglasian M, Barnebey H, Radcliffe N, Bacharach J. Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment. Transl Vis Sci Technol. 2024 Mar 1;13(3):10. doi: 10.1167/tvst.13.3.10.
PubMed 38488433
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Repeatability of a Novel Perimetric Test Administered Via a Virtual Reality Headset.
- ClinicalTrials.gov ID
- NCT06549010
- Acronym / sponsor ID
- ENV1
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Perimetric test, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Envision Health Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Illinois College of Optometry
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Visual field (VF) testing provided by the HFA is standard-of-care in glaucoma clinics and other ophthalmology and optometry practices. However, the HFA is a large device that does not allow for examination outside the clinic and can be uncomfortable for patients with limited mobility.
This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. The results of this study will potentially serve as pilot data for the design of a larger study that involves the full assessment of the VR headset and its VF test, based on various testing strategies.
Detailed description
Procedures:
- Ophthalmic screening: (a) Visual acuity, slit lamp exam, rebound tonometry (all subjects)
- OCT examination of the study eye with the Topcon Maestro2 Optical Coherence Tomography (OCT): (a) Standard Retinal Nerve Fiber Layer (RNFL), Optic Disc and Ganglion Cell Complex (GCC) scan patterns (i) Fundus photo is automatically obtained. (b) Abnormalities consistent with ophthalmic disease will be an exclusion for the healthy group of subjects. Reasonable and common artifacts that do not significantly impair the scan report will be accepted. (c) OCT abnormalities consistent with glaucoma are expected on the 30 glaucoma subjects.
- Once eligible, each patient will perform four (4) visual field tests: (a) once with the HFA Swedish Interactive Threshold Algorithm (SITA) Standard 24-2 pattern (i) Reliability criteria: False Positives no higher than 15% (b) three tests with the VR headset: (i) two tests with ZEST strategy (ii) one test with gamified ZEST strategy (c) Counter-balancing will be used to determine the order of (a) and (b). In particular, a study participant will either start with the HFA visual field test and then proceed to the three tests with the VR headset; or, start with the three VR tests and finish with the HFA visual field test. The sequence of the visual field tests for each study ID will be provided by the sponsor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 healthy subjects 30 glaucoma subjects
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Diagnostic Test: Perimetric test30 healthy subjects |
| Glaucoma subjects | Other | Diagnostic Test: Perimetric test30 glaucoma patients, 10 mild, 10 moderate, 10 severe |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age range: 25-70 years
- For normal subjects:
- For glaucoma subjects:
- Refractive Error:
- No past refractive eye surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Perimetric testThis study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. | Diagnostic test | Glaucoma subjects, Healthy subjects |
Primary outcome
Visual field perimetry light sensitivity
Time frame: 1 day
Localized differential light sensitivity threshold measured in decibels (dB)
Visual field perimetry foveal sensitivity
Time frame: 1 day
Foveal threshold in decibels (dB)
Visual field perimetry test duration
Time frame: 1 day
Test duration measured in minutes
1 secondary outcome
Optical Coherence Tomography (OCT)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 30114416Montesano G, Bryan SR, Crabb DP, Fogagnolo P, Oddone F, McKendrick AM, Turpin A, Lanzetta P, Perdicchi A, Johnson CA, Garway-Heath DF, Brusini P, Rossetti LM. A Comparison between the Compass Fundus Perimeter and the Humphrey Field Analyzer. Ophthalmology. 2019 Feb;126(2):242-251. doi: 10.1016/j.ophtha.2018.08.010. Epub 2018 Aug 14.
- Background: PubMed 35385053Marin-Franch I, Turpin A, Artes PH, Chong LX, McKendrick AM, Alawa KA, Wall M. The Open Perimetry Initiative: A framework for cross-platform development for the new generation of portable perimeters. J Vis. 2022 Apr 6;22(5):1. doi: 10.1167/jov.22.5.1.
- Background: PubMed 23492926Marin-Franch I, Swanson WH. The visualFields package: a tool for analysis and visualization of visual fields. J Vis. 2013 Mar 14;13(4):10. doi: 10.1167/13.4.10.
- Background: PubMed 38488433Bradley C, Ahmed IIK, Samuelson TW, Chaglasian M, Barnebey H, Radcliffe N, Bacharach J. Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment. Transl Vis Sci Technol. 2024 Mar 1;13(3):10. doi: 10.1167/tvst.13.3.10.
- Individual participant dataSharing planned: Yes. De-identified data and data analysis will be shared for communication of results and learning conclusions.
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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.
Michael Chaglasian, OD principal investigator
Illinois College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perimetric test in people with Glaucoma, run by Envision Health Technologies, Inc. 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 16 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Chaglasian, OD (312-949-7303, mchaglas@ico.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field perimetry light sensitivity (time frame: 1 day). 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 NCT06549010, which also lists 4 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 12 Aug 2024.