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| Name | Class |
|---|---|
| Olleyes, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Automatic Perimetry Humphrey Field Analyzer | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | three hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Reza Razeghinejad, MD | Wills Eye | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32941320 | Result | 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. |
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Glaucoma patients with mild or moderate visual field loss and subjects with healthy vision were enrolled to form two groups for comparison of two methods of visual field testing. Subjects unable to perform testing or test reliability did not meet inclusion criteria in 3 of the Healthy Controls and 18 of the Glaucoma Group. Therefore, 21 participants were excluded from results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, 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. |
| FG001 | Glaucoma Group | Subjects between 21 and 80 years of age with Mild or Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, 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. Standard Automatic Perimetry Humphrey Field Analyzer: 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 Analyzer: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | decibels | three hours | Eyes | Eyes |
|
3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | Healthy subjects between 21 and 80 years of age with no eye diseases. Eyes will have normal appearing optic nerve and retina, intraocular eye pressure less than 19 millimeters of mercury, normal, 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. Standard Automatic Perimetry Humphrey Field Analyzer: 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 Analyzer: 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. |
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Disadvantages of VisuALL are similar to standard automated perimetry. They rely on patient cooperation and concentration during visual field examination. In addition, the system does not include follow-up analysis. The head-mounted device may not be preferred by subjects with claustrophobic tendencies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Reza Razeghinejad, MD | Wills Eye Hospital | 12159283197 | reza@willseye.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2018 | Dec 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
| visuALL Field Analyzer | Diagnostic Test | 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. |
|
|
| 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. | three hours |
| BG001 | Glaucoma Group | Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); 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. Standard Automatic Perimetry Humphrey Field Analyzer: 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 Analyzer: 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. |
| BG002 | Total | Total of all reporting groups |
| Eyes |
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| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Mild to Moderate Glaucoma | Count of Participants | Participants | Participants |
|
| Number of eyes analyzed | Number | number of eyes | Participants |
|
| OG001 |
| Glaucoma Group |
Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Fifty-two eyes with reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); and spherical refraction less than 3 diopters and cylinder correction equal to 2 diopters or less. All subjects performed Standard Automatic Perimetry Humphrey Field Analyzer and visuALL Field Analyzer to measure peripheral and central visual field. |
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| Primary | 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. | The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their visual field (overall). | Posted | Mean | 1% Confidence Interval | decibels | three hours | Eyes | Eyes |
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|
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| Secondary | 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. | The overall mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across their inferior nasal visual field). | Posted | Mean | 1% Confidence Interval | decibels | three hours | Eyes | Eyes |
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| Secondary | 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. | The mean retinal sensitivity (lowest level of light detected) measured by two perimetry machines was compared in both normal and glaucoma subjects. This is the difference between the results of the two machines for healthy and glaucoma eyes across the superior hemifield portion of their visual field. | Posted | Mean | 1% Confidence Interval | decibels | three hours | Eyes | Eyes |
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| 28 |
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| EG001 | Glaucoma Group | Subjects between 21 and 80 years of age with Mild and Moderate Glaucoma. Eyes will have reliable standard automatic perimetry with no more than -6 mean deviation (mild glaucoma) and between -6 mean and -12 mean deviation (moderate glaucoma); 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. Standard Automatic Perimetry Humphrey Field Analyzer: 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 Analyzer: 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. | 0 | 44 | 0 | 44 | 0 | 44 |
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