An interventional study of Visual Performance tests and Brain-computer interface in Glaucoma, Macular Degeneration and Glaucoma Suspect, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.
Sponsored by University of Miami · Not applicable, Interventional, and Diagnostic
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.
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's enrollment of 115 is above the median of 61 across 964 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with diagnosed glaucoma will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests · Device: Brain-computer interface
Patients with suspicious of having glaucoma will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests · Device: Brain-computer interface
Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests
Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests
Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests
Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Diagnostic Test: Visual Performance tests
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.
Diagnostic Test: Visual Performance tests · Device: Brain-computer interface
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.
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.
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
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
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
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
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
| Milestone | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| Started | 14 | 89 | 12 | 0 | 0 | 0 | 0 |
| Completed | 9 | 63 | 6 | 0 | 0 | 0 | 0 |
| Not completed | 5 | 26 | 6 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 5 | 19 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 4 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 3 | 3 | 0 | 0 | 0 | 0 |
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.
| score on a scale | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| Visual Impairment Measured by Visual Functioning Test | 80.6 ± 5.3 | 74.2 ± 13.0 | 81.1 ± 10.4 | — | — | — | — |
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)
| eyes | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| Progression by BCI only | — | 33 | 7 | — | — | — | — |
| Progression by SAP only | — | 26 | 0 | — | — | — | — |
| Progression by BCI and SAP | — | 15 | 2 | — | — | — | — |
| No progression | — | 96 | 11 | — | — | — | — |
The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).
| years | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| SAP | — | 3.3 ± 1.3 | 2.9 ± 0.0 | — | — | — | — |
| BCI | — | 2.7 ± 1.5 | 2.9 ± 0.0 | — | — | — | — |
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.
| unitless | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| Standard Automated Perimetry Will be Assessed by the C-index | — | .652 | .667 | — | — | — | — |
The scores on the NEI VFQ-25 subscale ranges from 0 to 100, with a higher score indicating greater functioning.
| score on a scale | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group |
|---|---|---|---|---|---|---|---|
| Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 | 95.2 ± 6.1 | 91.3 ± 8.9 | 92.6 ± 5.1 | — | — | — | — |
Collected over 4.5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Control Group | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Glaucoma Group | 0/89 (0%) | 0/89 (0%) | 0/89 (0%) |
| Suspicious of Having Glaucoma Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Non-glaucomatous Optic Neuropathies Group | — | — | — |
| Age-related Macular Degeneration (AMD) Group | — | — | — |
| Retinal Degenerations Group | — | — | — |
| Other Diseases of Visual Pathways Group | — | — | — |
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.
| Age, Continuous(years) | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 72.2 ± 4.2 | 67.7 ± 9.7 | 67.2 ± 10.0 | — | — | — | — | 68.2 ± 9.3 |
| Sex: Female, Male(Participants) | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 52 | 4 | — | — | — | — | 64 |
| Male | 6 | 37 | 8 | — | — | — | — | 51 |
| Ethnicity (NIH/OMB)(Participants) | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | — | — | — | — | 2 |
| Not Hispanic or Latino | 14 | 87 | 12 | — | — | — | — | 113 |
| Unknown or Not Reported | 0 | 0 | 0 | — | — | — | — | 0 |
| Race (NIH/OMB)(Participants) | Healthy Control Group | Glaucoma Group | Suspicious of Having Glaucoma Group | Non-glaucomatous Optic Neuropathies Group | Age-related Macular Degeneration (AMD) Group | Retinal Degenerations Group | Other Diseases of Visual Pathways Group | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | — | — | — | — | 0 |
| Asian | 0 | 3 | 1 | — | — | — | — | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | — | — | — | — | 0 |
| Black or African American | 1 | 26 | 4 | — | — | — | — | 31 |
| White | 13 | 58 | 7 | — | — | — | — | 78 |
| More than one race | 0 | 0 | 0 | — | — | — | — | 0 |
| Unknown or Not Reported | 0 | 2 | 0 | — | — | — | — | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
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