Visual Field Defect, PeripheralNCT04786886
Patient Performance and Acceptance of Virtual Reality Visual Field Devices
A study testing VIrtual Reality Visual Field Exam in people with Visual Field Defect, Peripheral and Visual Field Defect, Nasal Step, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
- What is being tested?
- VIrtual Reality Visual Field Exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 2 Feb 2021
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient >13 years old at Bascom Palmer Eye Institute
- Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma
Who cannot join
- Adults unable to consent, pregnant women, prisoners
- Patients under the age of 13
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.
- Conditions
- Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
- Being tested
- VIrtual Reality Visual Field Exam
- Keywords
- Retinal Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIrtual Reality Visual Field ExamOther
Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Visual Field Group | Experimental | Participants in this group will have virtual reality visual field testing during standard of care follow-up visit. Receives: Other: VIrtual Reality Visual Field Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operational Effectiveness
Operational effectiveness will be reported as the length of the visit and virtual reality visual field exam testing times. Both will be measured in minutes.
Measured: Day 1
Medical Effectiveness as Measured by Visual Field Indexes
Medical effectiveness will be evaluated by visual field indexes, such as mean deviation, pattern standard deviation, and foveal threshold, which are all measured in decibels. These values are generated based on the participants' performance in the visual field exam.
Measured: Day 1
Medical Effectiveness as Measured by Glaucoma Hemifield Test
Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam.
Measured: Day 1
Reliability Indices
Reliability index is generated based on the participants' performance in the visual field exam.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start4 Nov 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Field Defect, PeripheralStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana L Grajewski, University of Miami
- Investigators
- Alana Grajewski, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786886
- Sponsor's protocol ID
- 20190679
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 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 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Performance and Acceptance of Virtual Reality Visual Field Devices
- ClinicalTrials.gov ID
- NCT04786886
- Acronym / sponsor ID
- 20190679
- Conditions
- Visual Field Defect, Peripheral, Visual Field Defect, Nasal Step, Visual Field Defect, Paracentral Scotoma of Both Eyes
- Keywords
- Retinal Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 8 Mar 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 research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Visual Field Group | Experimental | Other: VIrtual Reality Visual Field ExamParticipants in this group will have virtual reality visual field testing during standard of care follow-up visit. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient >13 years old at Bascom Palmer Eye Institute
- Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma
Key exclusion criteria (2 listed)
- Adults unable to consent, pregnant women, prisoners
- Patients under the age of 13
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 Visual Field ExamVirtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes. | Other | Virtual Reality Visual Field Group |
Primary outcome
Operational Effectiveness
Time frame: Day 1
Operational effectiveness will be reported as the length of the visit and virtual reality visual field exam testing times. Both will be measured in minutes.
Medical Effectiveness as Measured by Visual Field Indexes
Time frame: Day 1
Medical effectiveness will be evaluated by visual field indexes, such as mean deviation, pattern standard deviation, and foveal threshold, which are all measured in decibels. These values are generated based on the participants' performance in the visual field exam.
Medical Effectiveness as Measured by Glaucoma Hemifield Test
Time frame: Day 1
Medical effectiveness will be evaluated by the glaucoma hemifield test. This value is generated based on the participants' performance in the visual field exam.
Reliability Indices
Time frame: Day 1
Reliability index is generated based on the participants' performance in the visual field exam.
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 8 Mar 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.
Alana Grajewski, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIrtual Reality Visual Field Exam in people with Visual Field Defect, Peripheral and Visual Field Defect, Nasal Step, run by University of Miami 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 2 inclusion and 2 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 8 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 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?
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?
Operational Effectiveness (time frame: Day 1). The study lists 4 primary outcomes in all. 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 8 Mar 2021.