Visual Field Defect, PeripheralNCT05150197
Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease
A study testing VisuALL and Humphrey Visual Field in people with Visual Field Defect, Peripheral, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. Read more about this study
- Who is it for?
- Ages 4 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Field Defect, Peripheral
- What is being tested?
- VisuALL and Humphrey Visual Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients must be at least four (4) years old
- Cognitively normal (no developmental delay or syndrome)
- Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
- Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
- Do not have any ocular diseases that could interfere with the visual field testing
Who cannot join
- Developmental delay
- Inability to obtain consent
- Inability to understand English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Nikita Piryani, MD, 2624081232, nikita.piryani@duke.edu
About this study
Official title: Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test.
The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants.
Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.
- Conditions
- Visual Field Defect, Peripheral
- Being tested
- VisuALL, Humphrey Visual Field
- Keywords
- Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisuALLDevice
Virtual Reality Visual Field Device
Humphrey Visual FieldDevice
Standard of care Visual Field test
| Study group | Role | What they receive |
|---|---|---|
| Patient (pathology) group | Experimental | This group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field. Receives: Device: VisuALL; Device: Humphrey Visual Field |
| Control group | Other | This group will only perform the VisuALL Virtual Reality Visual Field. Receives: Device: VisuALL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean deviation results of visual field parameters
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Measured: During office visit, approximately 30 minutes
Pattern standard deviation results of visual field parameters
Pattern standard deviation of the visual field is one score calculated from device reading
Measured: During office visit, approximately 30 minutes
Sensitivity results of visual field parameters
Sensitivities are the results of each space in the visual field measured in decibels
Measured: During office visit, approximately 30 minutes
Secondary outcomes (4)
Percent of times that scotomas were visualized as measured by visual field tests
Measured: During office visit, approximately 30 minutes
Percent of participants stating satisfaction as measured by questionnaire
12 questions with strongly disagree to strongly agree
Measured: During office visit, approximately 5 minutes
Percent of patients able to use VisuALL in-office testing as measured by patient observation
Measured: During office visit, approximately 30 minutes
Percent of patients able to use VisuALL home testing as measured by device reading
Home testing will be done in a few patients that demonstrate facility with the device
Measured: During office visit, 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start19 Jan 2022
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visual Field Defect, PeripheralStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon F Freedman, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150197
- Sponsor's protocol ID
- Pro00109426
- Status last verified
- May 2026
- First submitted
- 17 Nov 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.
PubMed 32941320Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167/tvst.10.3.20.
PubMed 34003954
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Visual Field Testing as an Alternative to Standard Automated Perimetry in Childhood Eye Disease
- ClinicalTrials.gov ID
- NCT05150197
- Acronym / sponsor ID
- Pro00109426
- Conditions
- Visual Field Defect, Peripheral
- Keywords
- Virtual Reality Visual Field, Glaucoma, Neuro-ophthalmology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Dec 2021 (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.
The purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. This new visual field test (called VisuALL) is an FDA-approved virtual reality system which has been used in adults and children. This study will compare the performance of the VisuALL to the standard testing for peripheral vision, which is called the Humphrey Visual Field (HVF) test.
The study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. The test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. The test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. There may be a risk of loss of confidentiality. Participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. There are no direct benefits for participants.
Selected participants will be also be given training and then loaned a home VisuALL system to allow home visual field testing. If your child is selected, additional information would be provided.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient (pathology) group | Experimental | Device: VisuALL, Device: Humphrey Visual FieldThis group will perform both the standard of care Humphrey Visual Field (HVF) and the VisuALL Virtual Reality Visual Field. |
| Control group | Other | Device: VisuALLThis group will only perform the VisuALL Virtual Reality Visual Field. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients must be at least four (4) years old
- Cognitively normal (no developmental delay or syndrome)
- Be able to tolerate wearing the virtual reality goggles for at least 10 minutes
- Be able to provide informed consent of a parent/guardian (and assent if 12 years or older)
- Do not have any ocular diseases that could interfere with the visual field testing
Key exclusion criteria (3 listed)
- Developmental delay
- Inability to obtain consent
- Inability to understand English
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 |
|---|---|---|
| VisuALLVirtual Reality Visual Field Device | Device | Control group, Patient (pathology) group |
| Humphrey Visual FieldStandard of care Visual Field test | Device | Patient (pathology) group |
Primary outcome
Mean deviation results of visual field parameters
Time frame: During office visit, approximately 30 minutes
Mean deviation of the visual field is one score measured in decibels calculated from device reading
Pattern standard deviation results of visual field parameters
Time frame: During office visit, approximately 30 minutes
Pattern standard deviation of the visual field is one score calculated from device reading
Sensitivity results of visual field parameters
Time frame: During office visit, approximately 30 minutes
Sensitivities are the results of each space in the visual field measured in decibels
4 secondary outcomes
Percent of times that scotomas were visualized as measured by visual field tests
Time frame: During office visit, approximately 30 minutes
Percent of participants stating satisfaction as measured by questionnaire
Time frame: During office visit, approximately 5 minutes
Percent of patients able to use VisuALL in-office testing as measured by patient observation
Time frame: During office visit, approximately 30 minutes
Percent of patients able to use VisuALL home testing as measured by device reading
Time frame: During office visit, 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 32941320Razeghinejad R, Gonzalez-Garcia A, Myers JS, Katz LJ. Preliminary Report on a Novel Virtual Reality Perimeter Compared With Standard Automated Perimetry. J Glaucoma. 2021 Jan 1;30(1):17-23. doi: 10.1097/IJG.0000000000001670.
- Background: PubMed 34003954Montelongo M, Gonzalez A, Morgenstern F, Donahue SP, Groth SL. A Virtual Reality-Based Automated Perimeter, Device, and Pilot Study. Transl Vis Sci Technol. 2021 Mar 1;10(3):20. doi: 10.1167/tvst.10.3.20.
- 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.
Sharon F Freedman, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisuALL and Humphrey Visual Field in people with Visual Field Defect, Peripheral, run by Duke University 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon F Freedman, MD ((919) 681-3937, sharon.freedman@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean deviation results of visual field parameters (time frame: During office visit, approximately 30 minutes). 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 NCT05150197, which also lists 2 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 26 May 2026.