Visual Field TestsNCT04010383
Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device
An observational study of Visual Field Tests, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Field Tests
- What is being tested?
- virtual reality perimeter
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Aug 2019to 30 Dec 2020
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of glaucoma patients and patients with normal visual fields respecting the inclusion/exclusion criteria. There is no restriction in ethnicity.
Who may be able to join
- Cataract yes or no
- Age range 40 - 80 years- normal visual field (MD: < +2 dB)
- Refractive error within ±5 dpt. spherical equivalent
- Astigmatism of < -3 dpt.
- Visual acuity of ≥0.3 logMar (decimal ≥0.5)
- Experience in perimetry (history of at least one perimetry examination)
Show all 15Show fewer
- False positive or negative errors each less than 20% in each examination
- Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
- Early to moderate visual field loss (MD: +2 to +12 dB)
- Refractive error within ±5 dpt. spherical equivalent
- Astigmatism of < -3 dpt.
- Visual acuity of ≥0.3 logMar (decimal ≥0.5)
- Experience in perimetry (history of at least one perimetry examination)
- False positive or negative errors each less than 20% in each examination
- Cataract yes or no
Who cannot join
- Exclusion criteria are subjects younger than 40 and older than 80 years
- Inability to follow the procedure
- Insufficient knowledge of project language
- The history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
- Any history of epilepsy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Bern, Department of Ophthalmology
Bern, 3010
About this study
Official title: Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained.
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
- Conditions
- Visual Field Tests
- Being tested
- virtual reality perimeter
- Keywords
- Perimetry, Virtual reality device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality perimeterDiagnostic test
Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.
| Study group | Role | What they receive |
|---|---|---|
| normal visual field subjects | * Cataract yes or no
* Age range 40 - 80 years
* normal visual field (MD: < +2 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of < -3 dpt.
* Visual acuity of ≥0.3 logMar (decimal ≥0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination Receives: Diagnostic Test: virtual reality perimeter | |
| Glaucomatous subjects | * Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
* Early to moderate visual field loss (MD: +2 to +12 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of < -3 dpt.
* Visual acuity of ≥0.3 logMar (decimal ≥0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination
* Cataract yes or no
* Age range 40 - 80 years Receives: Diagnostic Test: virtual reality perimeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start2 Aug 2019
- Primary completion1 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Field TestsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- René G Höhn, Dr. med., Principal investigator, Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010383
- Sponsor's protocol ID
- 2018-01902
- Other IDs
- 2018
- Status last verified
- Feb 2021
- First submitted
- 3 Jul 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
- ClinicalTrials.gov ID
- NCT04010383
- Acronym / sponsor ID
- 2018-01902
- Conditions
- Visual Field Tests
- Keywords
- Perimetry, Virtual reality device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 8 Jul 2019 (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.
It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained.
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal visual field subjects | – | Diagnostic Test: virtual reality perimeter* Cataract yes or no * Age range 40 - 80 years * normal visual field (MD: < +2 dB) * Refractive error within ±5 dpt. spherical equivalent * Astigmatism of < -3 dpt. * Visual acuity of ≥0.3 logMar (decimal ≥0.5) * Experience in perimetry (history of at least one perimetry examination) * False positive or negative errors each less than 20% in each examination |
| Glaucomatous subjects | – | Diagnostic Test: virtual reality perimeter* Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma * Early to moderate visual field loss (MD: +2 to +12 dB) * Refractive error within ±5 dpt. spherical equivalent * Astigmatism of < -3 dpt. * Visual acuity of ≥0.3 logMar (decimal ≥0.5) * Experience in perimetry (history of at least one perimetry examination) * False positive or negative errors each less than 20% in each examination * Cataract yes or no * Age range 40 - 80 years |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of glaucoma patients and patients with normal visual fields respecting the inclusion/exclusion criteria. There is no restriction in ethnicity.
Key inclusion criteria (15 listed)
- Cataract yes or no
- Age range 40 - 80 years- normal visual field (MD: < +2 dB)
- Refractive error within ±5 dpt. spherical equivalent
- Astigmatism of < -3 dpt.
- Visual acuity of ≥0.3 logMar (decimal ≥0.5)
Key exclusion criteria (5 listed)
- Exclusion criteria are subjects younger than 40 and older than 80 years
- Inability to follow the procedure
- Insufficient knowledge of project language
- The history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
- Any history of epilepsy
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 |
|---|---|---|
| virtual reality perimeterBoth groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter. | Diagnostic test | Glaucomatous subjects, normal visual field subjects |
Primary outcome
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter
Time frame: 2 weeks
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Visual Field Tests
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World Sight Foundation Field Machine (WSFFM) Pilot
Glaucoma
Recruiting
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
Visual Field Defect, Peripheral
Enrolling by invitation
Effectiveness of a Large Language Model-Based Educational Tool on Visual Field Test Reliability in Glaucoma Patients
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Active, not recruitingObservational study
Visual Field Analysis With Artificial Intelligence
Glaucoma, Visual Field Defect
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.
René G Höhn, Dr. med. principal investigator
Department of Ophthalmology, University Hospital Bern, Berne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Field Tests, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 15 inclusion and 5 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 1 Mar 2021. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.