GlaucomaNCT03318549

BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

A study testing Visual Performance tests and Brain-computer interface in people with Glaucoma and Macular Degeneration, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Glaucoma, Macular Degeneration, Glaucoma Suspect
What is being tested?: Visual Performance tests and Brain-computer interface
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteUnited States
Study dates: 29 Oct 2018to 31 May 2023
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 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bascom Palmer Eye Institute
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

Conditions: Glaucoma, Macular Degeneration, Glaucoma Suspect, Optic Neuropathy, Retinal Degeneration, Visual Pathway Disorder
Being tested: Visual Performance tests, Brain-computer interface
Keywords: virtual reality, glaucoma, age related macular degeneration, quality of life, visual field, optical coherence tomography, brain-computer interface
Medical subject headings: Glaucoma, Macular Degeneration, Ocular Hypertension, Optic Nerve Diseases, Retinal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Visual Performance testsDiagnostic test
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 interfaceDevice
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.

Study groups in NCT03318549
Study group	Role	What they receive
Glaucoma group	Other	Patients with diagnosed glaucoma will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests; Device: Brain-computer interface
Suspicious of having glaucoma group	Other	Patients with suspicious of having glaucoma will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests; Device: Brain-computer interface
Non-glaucomatous optic neuropathies group	Other	Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests
Age-related macular degeneration (AMD) group	Other	Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests
Retinal degenerations group	Other	Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests
Other diseases of visual pathways group	Other	Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years. Receives: Diagnostic Test: Visual Performance tests
Healthy control group	Other	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. Receives: Diagnostic Test: Visual Performance tests; Device: Brain-computer interface

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: 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).
Measured: 4.5 years

Secondary outcomes (2)

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.
Measured: 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.
Measured: 4.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201831 May 2023

First posted24 Oct 2017
Study start29 Oct 2018
Primary completion31 May 2023
Study completion31 May 2023

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.
Other trials for GlaucomaStudies 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: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03318549
Sponsor's protocol ID: 20240020
Other IDs: Pro00088016, R01EY029885
Status last verified: Nov 2024
First submitted: 19 Oct 2017
Last updated: 26 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
ClinicalTrials.gov ID: NCT03318549
Acronym / sponsor ID: 20240020
Conditions: Glaucoma, Macular Degeneration, Glaucoma Suspect, Optic Neuropathy, Retinal Degeneration, Visual Pathway Disorder
Keywords: virtual reality, glaucoma, age related macular degeneration, quality of life, visual field, optical coherence tomography, brain-computer interface
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: 29 Oct 2018 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 24 Oct 2017 (actual)
Results: Posted 26 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Glaucoma group	Other	Diagnostic Test: Visual Performance tests, Device: Brain-computer interfacePatients with diagnosed glaucoma will be in the group for up to 5 years.
Suspicious of having glaucoma group	Other	Diagnostic Test: Visual Performance tests, Device: Brain-computer interfacePatients with suspicious of having glaucoma will be in the group for up to 5 years.
Non-glaucomatous optic neuropathies group	Other	Diagnostic Test: Visual Performance testsPatients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
Age-related macular degeneration (AMD) group	Other	Diagnostic Test: Visual Performance testsPatients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
Retinal degenerations group	Other	Diagnostic Test: Visual Performance testsPatients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
Other diseases of visual pathways group	Other	Diagnostic Test: Visual Performance testsOther diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
Healthy control group	Other	Diagnostic Test: Visual Performance tests, Device: Brain-computer interfacePatients 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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.

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
Visual Performance testsParticipants 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.	Diagnostic test	Age-related macular degeneration (AMD) group, Glaucoma group, Healthy control group, Non-glaucomatous optic neuropathies group, Other diseases of visual pathways group, Retinal degenerations group, Suspicious of having glaucoma group
Brain-computer interfaceThe 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.	Device	Glaucoma group, Healthy control group, Suspicious of having glaucoma group

Primary outcome

Visual Impairment Measured by Visual Functioning Test
Time frame: 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
Time frame: 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
Time frame: 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).

2 secondary outcomes

Standard Automated Perimetry Will be Assessed by the C-index
Time frame: 4.5 years
Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25
Time frame: 4.5 years

Results and safety

Results posted to the registry on 26 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Control Group	14	9
Glaucoma Group	89	63
Suspicious of Having Glaucoma Group	12	6
Non-glaucomatous Optic Neuropathies Group	0	0
Age-related Macular Degeneration (AMD) Group	0	0
Retinal Degenerations Group	0	0
Other Diseases of Visual Pathways Group	0	0

Primary outcome: Visual Impairment Measured by Visual Functioning Test

Time frame: 4.5 years. Mean (Standard Deviation). Unit: score on a scale

Measure	Healthy Control Group n = 14	Glaucoma Group n = 88	Suspicious of Having Glaucoma Group n = 11	Non-glaucomatous Optic Neuropathies Group n = 0	Age-related Macular Degeneration (AMD) Group n = 0	Retinal Degenerations Group n = 0	Other Diseases of Visual Pathways Group n = 0
Value	80.6 (5.3)	74.2 (13.0)	81.1 (10.4)	–	–	–	–

Healthy Control Group vs Glaucoma Group: p = 0.011, t-test, 2 sided
Glaucoma Group vs Suspicious of Having Glaucoma Group: p = 0.022, t-test, 2 sided

Population analysed: 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.

Primary outcome: Number of Eyes Showing Progression

Time frame: 4.5 years. Count of units. Unit: eyes

Measure	Healthy Control Group n = 0	Glaucoma Group n = 88	Suspicious of Having Glaucoma Group n = 11	Non-glaucomatous Optic Neuropathies Group n = 0	Age-related Macular Degeneration (AMD) Group n = 0	Retinal Degenerations Group n = 0	Other Diseases of Visual Pathways Group n = 0
Progression by BCI only	–	33	7	–	–	–	–
Progression by SAP only	–	26	0	–	–	–	–
Progression by BCI and SAP	–	15	2	–	–	–	–
No progression	–	96	11	–	–	–	–

Glaucoma Group vs Suspicious of Having Glaucoma Group: p = 0.303, Chi-squared

Primary outcome: Time to Detect Progression Measured in Years

Time frame: 4.5 years. Mean (Standard Deviation). Unit: years

Measure	Healthy Control Group n = 0	Glaucoma Group n = 11	Suspicious of Having Glaucoma Group n = 1	Non-glaucomatous Optic Neuropathies Group n = 0	Age-related Macular Degeneration (AMD) Group n = 0	Retinal Degenerations Group n = 0	Other Diseases of Visual Pathways Group n = 0
SAP	–	3.3 (1.3)	2.9 (0.0)	–	–	–	–
BCI	–	2.7 (1.5)	2.9 (0.0)	–	–	–	–

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Control Group	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Glaucoma Group	0 of 89 (0%)	0 of 89 (0%)	0 of 89
Suspicious of Having Glaucoma Group	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Non-glaucomatous Optic Neuropathies Group	0 of 0	0 of 0	0
Age-related Macular Degeneration (AMD) Group	0 of 0	0 of 0	0
Retinal Degenerations Group	0 of 0	0 of 0	0
Other Diseases of Visual Pathways Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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. A limited number of patients reached the 5-year follow-up mark, which did not provide enough power for progression analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Felipe A Medeiros, MD, PhD principal investigator

University of Miami

Henry Tseng, MD, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Visual Performance tests and Brain-computer interface in people with Glaucoma and Macular Degeneration, run by University of Miami 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 3 inclusion and 1 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 26 Nov 2024. 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 26 Nov 2024). 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?

Visual Impairment Measured by Visual Functioning Test (time frame: 4.5 years). The study lists 3 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 NCT03318549.

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 26 Nov 2024.