Glaucoma, Open-AngleNCT03804684
visuALL Field Analyzer (vFA) Compared to Standard Humphrey Automated Perimetry
A study testing Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer in people with Glaucoma, Open-Angle, run by Wills Eye at 1 site in United States.
Trial summary
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP). Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 20 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21 to 80 years
- Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
- mild glaucoma subjects with less than -6 mean deviation
- moderate glaucoma subjects with -6 to -12 mean deviation
Who cannot join
- spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
- Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
- Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
- SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
- Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
- History of systemic condition known to affect visual function
- History of medication known to affect visual function
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).
Read the detailed description
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.
Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.
The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Standard Automatic Perimetry Humphrey Field Analyzer, visuALL Field Analyzer
- Keywords
- open angle glaucoma, visual field, Standard Automatic Perimetry
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Automatic Perimetry Humphrey Field AnalyzerDiagnostic test
Also called SAP HFA
Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.
visuALL Field AnalyzerDiagnostic test
Also called vFA
visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Healthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. Receives: Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer |
| Mild and Moderate Glaucoma | Experimental | Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. Receives: Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer; Diagnostic Test: visuALL Field Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Retinal Sensitivity From Two Machines
Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
Measured: three hours
Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.
Measured: three hours
Secondary outcomes (2)
Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the inferior nasal visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the inferior (lower) nasal portion of the visual field, between two testing machines.
Measured: three hours
Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the superior (upper) hemifield portion of the visual field. This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field in the superior hemifield, between two testing machines.
Measured: three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start8 Jan 2019
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Olleyes, Inc.
- Responsible party
- Principal investigator, M. Reza Razeghinejad MD, Wills Eye
- Investigators
- M Reza Razeghinejad, MD, Principal investigator, Wills Eye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804684
- Sponsor's protocol ID
- IRB Control #18-768E
- Status last verified
- Jun 2022
- First submitted
- 11 Jan 2019
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 32941320
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does the visuALL Field Analyzer (vFA) Compare to Standard Automatic Perimetry (SAP) in Patients With Mild and Moderate Chronic Open Angle Glaucoma (COAG) and Subjects Without Eye Problems?
- ClinicalTrials.gov ID
- NCT03804684
- Acronym / sponsor ID
- IRB Control #18-768E
- Conditions
- Glaucoma, Open-Angle
- Keywords
- open angle glaucoma, visual field, Standard Automatic Perimetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Olleyes, Inc.
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine age-adjusted reference values of the visuALL Field Analyzer (vFA) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a Standard Automatic Perimetry (SAP).
Detailed description
Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. The current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc.
Several devices have been developed since the advent of the Octopus Perimeter 3-5 and the Humphrey Field Analyzer (HFA), in an effort to improve the test reliability and patient comfort.
The main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a Head Mounted Device (HMD) with eye tracking capabilities. Other objectives of this study include the development of an initial reference database and comparison of the measured parameters with HFA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer, Diagnostic Test: visuALL Field AnalyzerHealthy subjects between 21 and 80 years of age with no eye diseases (normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal and reliable standard automatic perimetry, and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. |
| Mild and Moderate Glaucoma | Experimental | Diagnostic Test: Standard Automatic Perimetry Humphrey Field Analyzer, Diagnostic Test: visuALL Field AnalyzerSubjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have a reliable standard automatic perimetry with no more than -6 mean deviation (Mild) and between -6 mean and -12 mean deviation (Moderate). Spherical refraction will be less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects will perform Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 21 to 80 years
- Healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (SAP).
- mild glaucoma subjects with less than -6 mean deviation
- moderate glaucoma subjects with -6 to -12 mean deviation
Key exclusion criteria (7 listed)
- spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters
- Unreliable SAP (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts)
- Unreliable visuALL Field Analyzer (vFA) (greater than 25% false positive, excessive fixation losses)
- SAP abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma
- Intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification)
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 |
|---|---|---|
| Standard Automatic Perimetry Humphrey Field AnalyzerAlso: SAP HFAStandard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting. | Diagnostic test | Healthy Controls, Mild and Moderate Glaucoma |
| visuALL Field AnalyzerAlso: vFAvisuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting. | Diagnostic test | Healthy Controls, Mild and Moderate Glaucoma |
Primary outcome
Mean Retinal Sensitivity From Two Machines
Time frame: three hours
Mean (Average) retinal sensitivity to light as measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers translate to dimmer light which when detected means better vision.
Global Correlation (Agreement Between Two Machines in the Overall Visual Field)
Time frame: three hours
Correlation (Agreement) between Humphrey Visual Field and VisuALL retinal sensitivity as measured by mean deviation (light measurement in decibels) in multiple spots across the central and peripheral retina (entire visual field). This is the amount of agreement of the measure threshold, which is the lowest level of light detected in different points across the visual field (overall), between two testing machines.
2 secondary outcomes
Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field)
Time frame: three hours
Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field
Time frame: three hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- 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.
M Reza Razeghinejad, MD principal investigator
Wills Eye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer in people with Glaucoma, Open-Angle, run by Wills Eye 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 4 inclusion and 7 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 29 Jun 2022. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Retinal Sensitivity From Two Machines (time frame: three hours). 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 NCT03804684, 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 29 Jun 2022; AzTrials last refreshed its copy on 2 Nov 2026.