Glaucoma, Open-Angle
Conditions
Keywords
open angle glaucoma, visual field, Standard Automatic Perimetry
Brief 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).
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.
Interventions
DIAGNOSTIC_TESTStandard 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.
DIAGNOSTIC_TESTvisuALL 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.
Sponsors
Olleyes, Inc.
Wills Eye
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Retinal Sensitivity From Two Machines | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field) | 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 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. |
| Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field | 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 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 50 |
| 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. | 44 |
| 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. | 52 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subjects unable to perform testing or test reliability did not meet inclusion criteria. | 3 | 18 |
Baseline characteristics
| Characteristic | Healthy Controls | Total | Glaucoma Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 29 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 43 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 69 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mild to Moderate Glaucoma | 0 Participants | 44 Participants | 44 Participants |
| Number of eyes analyzed eyes with mild visual field defects | 0 number of eyes | 36 number of eyes | 36 number of eyes |
| Number of eyes analyzed eyes with moderate visual field defects | 0 number of eyes | 13 number of eyes | 13 number of eyes |
| Number of eyes analyzed eyes with severe visual field defects | 0 number of eyes | 3 number of eyes | 3 number of eyes |
| Number of eyes analyzed total eyes analyzed | 50 number of eyes | 102 number of eyes | 52 number of eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 34 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 37 Participants | 20 Participants |
| Region of Enrollment United States | 28 participants | 72 participants | 44 participants |
| Sex: Female, Male Female | 18 Participants | 39 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 33 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 44 |
| other Total, other adverse events | 0 / 28 | 0 / 44 |
| serious Total, serious adverse events | 0 / 28 | 0 / 44 |
Outcome results
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.
Time frame: three hours
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Controls | Global Correlation (Agreement Between Two Machines in the Overall Visual Field) | 0.5 decibels |
| Glaucoma Group | Global Correlation (Agreement Between Two Machines in the Overall Visual Field) | 0.8 decibels |
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.
Time frame: three hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Global field from Humphrey Visual Field | 29.9 decibels | Standard Deviation 1.4 |
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Global field from VisuALL | 28.7 decibels | Standard Deviation 1.3 |
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Inferior nasal quadrant from Humphrey Visual Field | 30.3 decibels | Standard Deviation 1.3 |
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Inferior nasal quadrant from VisuALL | 28.7 decibels | Standard Deviation 1.6 |
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Superior hemifield from Humphrey Visual Field | 29.5 decibels | Standard Deviation 1.5 |
| Healthy Controls | Mean Retinal Sensitivity From Two Machines | Superior hemifield from VisuALL | 28.6 decibels | Standard Deviation 1.6 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Superior hemifield from Humphrey Visual Field | 23.7 decibels | Standard Deviation 5 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Global field from Humphrey Visual Field | 24.8 decibels | Standard Deviation 3.9 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Inferior nasal quadrant from VisuALL | 23.3 decibels | Standard Deviation 6.9 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Global field from VisuALL | 22.9 decibels | Standard Deviation 4.9 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Superior hemifield from VisuALL | 21.8 decibels | Standard Deviation 6.5 |
| Glaucoma Group | Mean Retinal Sensitivity From Two Machines | Inferior nasal quadrant from Humphrey Visual Field | 24.8 decibels | Standard Deviation 5.8 |
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.
Time frame: three hours
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Controls | Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field) | 0.3 decibels |
| Glaucoma Group | Inferior Nasal Quadrant Correlation (Agreement Between Two Machines in the Inferior Nasal Visual Field) | 0.8 decibels |
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.
Time frame: three hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Controls | Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field | 0.4 decibels |
| Glaucoma Group | Superior Hemifield Correlation (Agreement Between Two Machines in the Superior Hemifield Visual Field | 0.6 decibels |