Evaluation of Visual and Task Performance

Sponsor
Duke University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03318549
Collaborator
(none)
250
1
7
50.1
5

Study Details

Study Description

Brief Summary

Better understand the impact of visual impairment on daily task performance in patients with eye diseases of the visual pathways, such as glaucoma and age-related macular degeneration (AMD).

Longitudinal study, with biannual visits, including patients with: glaucoma, suspected of having glaucoma, non-glaucomatous optic neuropathies, AMD, retinal degenerations, other diseases involving the visual pathways, besides healthy controls. Subjects will perform standard ophthalmological exams, and the following research tests: psychophysical, eye tracking, electroencephalogram, driving simulator, virtual reality, balance assessment, and questionnaires.

This proposal also includes an investigation of the ability of longitudinal brain-computer interface (BCI) multifocal steady-state visual-evoked potentials (mfSSVEP) parameters in detecting glaucoma progression. We hypothesize that BCI mfSSVEP data will be able to successfully detect progression and measure rates of change, as compared to functional assessment by standard automated perimetry (SAP) and structural assessment by optical coherence tomography.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Visual Performance tests
  • Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Actual Study Start Date :
Oct 29, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Glaucoma

Patients with diagnosed glaucoma

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
The brain-computer interface (BCI) device 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.

Other: Suspicious of having glaucoma

Patients with suspicious of having glaucoma based on intra-ocular pressure or optic nerve photographs with glaucoma appearance

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
The brain-computer interface (BCI) device 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.

Other: Non-glaucomatous optic neuropathies;

Patients with optic neuropathies that do not look glaucomatous-like

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Other: Age-related macular degeneration (AMD)

Patients with diagnosed age-related macular degeneration

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Other: Retinal degenerations

Patients with other retinal degenerations excluding AMD

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Other: Other diseases of visual pathways

Other diseases of the visual pathway not included in the previous groups

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Other: Healthy control group

Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups

Diagnostic Test: Visual Performance tests
The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.

Device: Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
The brain-computer interface (BCI) device 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.

Outcome Measures

Primary Outcome Measures

  1. Visual impairment measured by a composite of scores [5 years]

    The study team will evaluate visual impairment through the following scores obtained from the following composite tests: ophthalmological evaluation, questionnaires, psychophysics tests, eye tracking devices, electroencephalogram exams, driving simulator, virtual reality tests, and balance assessment.

  2. Proportion of eyes showing progression [5 years]

    The proportion of eyes showing progression will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry), matched by specificity.

  3. Time to detect progression [5 years]

    The time to detect progression will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).

Secondary Outcome Measures

  1. Predictive ability to detect progression (c-index) [5 years]

    The ability of home-based BCI testing to predict future progression on standard automated perimetry will be assessed by the c-index.

  2. Ability to predict changes in patient-reported quality of life (c-index) [5 years]

    The ability of home-based BCI testing to predict changes in patient-reported quality of life data as assessed by the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be assessed by the c-index.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Eye Center Durham North Carolina United States 27701

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Felipe A Medeiros, MD, PhD, Duke University
  • Principal Investigator: Henry Tseng, MD, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03318549
Other Study ID Numbers:
  • Pro00088016
First Posted:
Oct 24, 2017
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2022