Glaucoma, Macular Degeneration, Glaucoma Suspect, Optic Neuropathy, Retinal Degeneration, Visual Pathway Disorder
Conditions
Keywords
virtual reality, glaucoma, age related macular degeneration, quality of life, visual field, optical coherence tomography, brain-computer interface
Brief summary
The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.
Interventions
DIAGNOSTIC_TESTVisual Performance tests
Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
DEVICEBrain-computer interface
The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years.
Sponsors
National Eye Institute (NEI)
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be between the ages of 18 and 90 years old; * Both males and females will be included. * Be able and willing to provide signed informed consent and follow study instructions
Exclusion criteria
* Subjects will be excluded if they present with any systemic conditions that in the opinion of the Principal Investigator may prevent them from completing the tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Impairment Measured by Visual Functioning Test | 4.5 years | The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment. |
| Number of Eyes Showing Progression | 4.5 years | The number of eyes showing progression (expressed in percentage) will be compared between the home-based Brain-computer interface (BCI) testing and standard clinical testing (standard automated perimetry, SAP) |
| Time to Detect Progression Measured in Years | 4.5 years | The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard Automated Perimetry Will be Assessed by the C-index | 4.5 years | c-index will be calculated by the proportion of concordant pairs divided by the total number of possible evaluation pairs for progression. c-index is unitless. |
| Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 | 4.5 years | The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning. |
Countries
United States
Participant flow
Pre-assignment details
No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 14 |
| Healthy Control Group Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 28 |
| Glaucoma Group Patients with diagnosed glaucoma will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 89 |
| Glaucoma Group Patients with diagnosed glaucoma will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 178 |
| Suspicious of Having Glaucoma Group Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 12 |
| Suspicious of Having Glaucoma Group Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare.
Brain-computer interface: The brain-computer interface (BCI) consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle. The test is done in person and may take up to 30 minutes, once every 6 months for up to 5 years. | 24 |
| Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Non-glaucomatous Optic Neuropathies Group Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Age-related Macular Degeneration (AMD) Group Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Retinal Degenerations Group Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Other Diseases of Visual Pathways Group Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Visual Performance tests: Participants came to the clinic in person for 2 hours for visual performance tests once every 6 months for up to 5 years. These tests included virtual reality tests and tests on a computer screen to investigate performance during simulated daily life activities, such as driving, situations of low contrast and glare. | 0 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 4 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 19 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Total |
|---|---|---|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 4.2 | 67.7 years STANDARD_DEVIATION 9.7 | 67.2 years STANDARD_DEVIATION 10 | 68.2 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 87 Participants | 12 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 26 Participants | 4 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 58 Participants | 7 Participants | 78 Participants |
| Sex: Female, Male Female | 8 Participants | 52 Participants | 4 Participants | 64 Participants |
| Sex: Female, Male Male | 6 Participants | 37 Participants | 8 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 89 | 0 / 12 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 14 | 0 / 89 | 0 / 12 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 14 | 0 / 89 | 0 / 12 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Eyes Showing Progression
The number of eyes showing progression (expressed in percentage) will be compared between the home-based Brain-computer interface (BCI) testing and standard clinical testing (standard automated perimetry, SAP)
Time frame: 4.5 years
Population: Two subjects with eyes with visual function tests with low reliability scores were excluded from the analysis. Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group. Healthy Control Group Arm, participants in this Arm were not assessed for this endpoint, and therefore, no data were collected.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Glaucoma Group | Number of Eyes Showing Progression | Progression by BCI only | 33 eyes |
| Glaucoma Group | Number of Eyes Showing Progression | Progression by SAP only | 26 eyes |
| Glaucoma Group | Number of Eyes Showing Progression | Progression by BCI and SAP | 15 eyes |
| Glaucoma Group | Number of Eyes Showing Progression | No progression | 96 eyes |
| Suspicious of Having Glaucoma Group | Number of Eyes Showing Progression | No progression | 11 eyes |
| Suspicious of Having Glaucoma Group | Number of Eyes Showing Progression | Progression by BCI only | 7 eyes |
| Suspicious of Having Glaucoma Group | Number of Eyes Showing Progression | Progression by BCI and SAP | 2 eyes |
| Suspicious of Having Glaucoma Group | Number of Eyes Showing Progression | Progression by SAP only | 0 eyes |
p-value: 0.303Chi-squared
Primary
Time to Detect Progression Measured in Years
The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).
Time frame: 4.5 years
Population: Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group. Healthy Control Group Arm, participants in this Arm were not assessed for this endpoint, and therefore, no data were collected. Data collected for progressing eyes with a minimum of 1.5 years of follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Glaucoma Group | Time to Detect Progression Measured in Years | SAP | 3.3 years | Standard Deviation 1.3 |
| Glaucoma Group | Time to Detect Progression Measured in Years | BCI | 2.7 years | Standard Deviation 1.5 |
| Suspicious of Having Glaucoma Group | Time to Detect Progression Measured in Years | SAP | 2.9 years | Standard Deviation 0 |
| Suspicious of Having Glaucoma Group | Time to Detect Progression Measured in Years | BCI | 2.9 years | Standard Deviation 0 |
Primary
Visual Impairment Measured by Visual Functioning Test
The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment.
Time frame: 4.5 years
Population: Two subjects with eyes with visual function tests with low reliability scores were excluded from the analysis. Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control Group | Visual Impairment Measured by Visual Functioning Test | 80.6 score on a scale | Standard Deviation 5.3 |
| Glaucoma Group | Visual Impairment Measured by Visual Functioning Test | 74.2 score on a scale | Standard Deviation 13 |
| Suspicious of Having Glaucoma Group | Visual Impairment Measured by Visual Functioning Test | 81.1 score on a scale | Standard Deviation 10.4 |
p-value: 0.011t-test, 2 sided
p-value: 0.022t-test, 2 sided
Secondary
Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25
The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning.
Time frame: 4.5 years
Population: Subjects with questionnaires with incomplete responses were excluded from the analysis. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Control Group | Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 | 95.2 score on a scale | Standard Deviation 6.1 |
| Glaucoma Group | Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 | 91.3 score on a scale | Standard Deviation 8.9 |
| Suspicious of Having Glaucoma Group | Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 | 92.6 score on a scale | Standard Deviation 5.1 |
p-value: 0.132t-test, 2 sided
p-value: 0.647t-test, 2 sided
Secondary
Standard Automated Perimetry Will be Assessed by the C-index
c-index will be calculated by the proportion of concordant pairs divided by the total number of possible evaluation pairs for progression. c-index is unitless.
Time frame: 4.5 years
Population: Two subjects with eyes with visual function tests with low reliability scores were excluded from the analysis. Monocular patients were included. No patients were enrolled during the study period for groups: Non-glaucomatous optic neuropathies group; Age-related macular degeneration (AMD) group; Retinal degenerations group; Other diseases of visual pathways group. Healthy Control Group Arm: participants in this Arm were not assessed for this endpoint, and therefore, no data were collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Glaucoma Group | Standard Automated Perimetry Will be Assessed by the C-index | .652 unitless |
| Suspicious of Having Glaucoma Group | Standard Automated Perimetry Will be Assessed by the C-index | .667 unitless |