GlaucomaNCT04994457
Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
An observational study of Glaucoma, 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 1 year to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Virtual Reality Visual Field and Standard Automated Perimetry
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2021to 21 Jun 2024
- 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 1 year to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals
Who may be able to join
- Any individual who is physically able to take a virtual reality visual field test
- Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
- Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)
Who cannot join
- Adults unable to consent, prisoners
- Participants who are too tired to take a visual field test
- Participants who refuse to consent
- Individuals who are functionally unable to use VRVF
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
- Glaucoma
- Being tested
- Virtual Reality Visual Field, Standard Automated Perimetry
- Keywords
- Visual Field, 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.
Virtual Reality Visual FieldDevice
A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses
Standard Automated PerimetryDiagnostic test
Standard of care perimeter
| Study group | Role | What they receive |
|---|---|---|
| Adults with Glaucoma or Suspected Glaucoma | Adults with Glaucoma or Suspected Glaucoma, who have previously had standard automated perimetry (SAP) and will receive virtual reality visual field (VRVF) as part of the standard of care Receives: Device: Virtual Reality Visual Field | |
| Visual Field Naive Adults | Visual Field Naive Adults will receive SAP and VRVF Receives: Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry | |
| Children with Glaucoma or Suspected Glaucoma | Children with Glaucoma or Suspected Glaucoma, who have previously had SAP and will receive VRVF as part of the standard of care Receives: Device: Virtual Reality Visual Field | |
| Visual Field Naive Children | Visual Field Naive Children will receive SAP and VRVF Receives: Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry | |
| Remote Care Arm | Glaucoma or Suspected Glaucoma participants, who have previously had SAP and will receive VRVF at their home Receives: Device: Virtual Reality Visual Field | |
| Ptosis Arm | Patients diagnosed with Ptosis, brow ptosis, or dermatochalasis, will receive a specialized version of VRVF and SAP, specifically to detect ptosis Receives: Device: Virtual Reality Visual Field; Diagnostic Test: Standard Automated Perimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of VRVF compared to SAP
Sensitivity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP
Measured: Day 1
Specificity of VRVF compared to SAP
Specificity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP
Measured: Day 1
Secondary outcomes (1)
Variability of Mean Deviation
Variability of the mean deviation scores obtained from VRVF and SAP
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 posted6 Aug 2021
- Study start30 Oct 2021
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Bitrian, University of Miami
- Investigators
- Elena Bitrian, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994457
- Sponsor's protocol ID
- 20210472
- Status last verified
- Jun 2024
- First submitted
- 29 Jul 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
McLaughlin DE, Savatovsky EJ, O'Brien RC, Vanner EA, Munshi HK, Pham AH, Grajewski AL. Reliability of Visual Field Testing in a Telehealth Setting Using a Head-Mounted Device: A Pilot Study. J Glaucoma. 2024 Jan 1;33(1):15-23. doi: 10.1097/IJG.0000000000002290. Epub 2023 Aug 14.
PubMed 37647317
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Performance on Virtual Reality Visual Field Devices as Compared to Standard of Care
- ClinicalTrials.gov ID
- NCT04994457
- Acronym / sponsor ID
- 20210472
- Conditions
- Glaucoma
- Keywords
- Visual Field, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 6 Aug 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adults with Glaucoma or Suspected Glaucoma | – | Device: Virtual Reality Visual FieldAdults with Glaucoma or Suspected Glaucoma, who have previously had standard automated perimetry (SAP) and will receive virtual reality visual field (VRVF) as part of the standard of care |
| Visual Field Naive Adults | – | Device: Virtual Reality Visual Field, Diagnostic Test: Standard Automated PerimetryVisual Field Naive Adults will receive SAP and VRVF |
| Children with Glaucoma or Suspected Glaucoma | – | Device: Virtual Reality Visual FieldChildren with Glaucoma or Suspected Glaucoma, who have previously had SAP and will receive VRVF as part of the standard of care |
| Visual Field Naive Children | – | Device: Virtual Reality Visual Field, Diagnostic Test: Standard Automated PerimetryVisual Field Naive Children will receive SAP and VRVF |
| Remote Care Arm | – | Device: Virtual Reality Visual FieldGlaucoma or Suspected Glaucoma participants, who have previously had SAP and will receive VRVF at their home |
| Ptosis Arm | – | Device: Virtual Reality Visual Field, Diagnostic Test: Standard Automated PerimetryPatients diagnosed with Ptosis, brow ptosis, or dermatochalasis, will receive a specialized version of VRVF and SAP, specifically to detect ptosis |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who are glaucoma or glaucoma suspect who are being seen at Bascom Palmer Eye Institute and/or healthy individuals
Key inclusion criteria (3 listed)
- Any individual who is physically able to take a virtual reality visual field test
- Patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma, or have other visual field defects, and normal individual
- Age: Individuals who are old enough to comprehend the instructions and procedures (1-90)
Key exclusion criteria (4 listed)
- Adults unable to consent, prisoners
- Participants who are too tired to take a visual field test
- Participants who refuse to consent
- Individuals who are functionally unable to use VRVF
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 FieldA head-mounted perimeter with a wireless remote connected to a laptop that monitors responses | Device | Adults with Glaucoma or Suspected Glaucoma, Children with Glaucoma or Suspected Glaucoma, Ptosis Arm, Remote Care Arm, Visual Field Naive Adults, Visual Field Naive Children |
| Standard Automated PerimetryStandard of care perimeter | Diagnostic test | Ptosis Arm, Visual Field Naive Adults, Visual Field Naive Children |
Primary outcome
Sensitivity of VRVF compared to SAP
Time frame: Day 1
Sensitivity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP
Specificity of VRVF compared to SAP
Time frame: Day 1
Specificity of VRVF will be determined by comparing Hodapp Anderson Parrish (HAP) Scores, which assess the severity of visual field defects, to those of SAP
1 secondary outcome
Variability of Mean Deviation
Time frame: Day 1
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 27 Jun 2024.
- Derived from this study: PubMed 37647317McLaughlin DE, Savatovsky EJ, O'Brien RC, Vanner EA, Munshi HK, Pham AH, Grajewski AL. Reliability of Visual Field Testing in a Telehealth Setting Using a Head-Mounted Device: A Pilot Study. J Glaucoma. 2024 Jan 1;33(1):15-23. doi: 10.1097/IJG.0000000000002290. Epub 2023 Aug 14.
- 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.
Elena Bitrian, 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?
An observational study of Glaucoma, 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 3 inclusion and 4 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 27 Jun 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?
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?
Sensitivity of VRVF compared to SAP (time frame: Day 1). The study lists 2 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 NCT04994457, which also lists 1 linked publication.
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 27 Jun 2024.