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Evaluation of Visual and Task Performance

Primary Purpose

Glaucoma, Macular Degeneration, Glaucoma Suspect

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Performance tests
Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring virtual reality, glaucoma, age related macular degeneration, quality of life, visual field, optical coherence tomography, brain-computer interface

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Duke Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Other

Other

Other

Other

Other

Other

Other

Arm Label

Glaucoma

Suspicious of having glaucoma

Non-glaucomatous optic neuropathies;

Age-related macular degeneration (AMD)

Retinal degenerations

Other diseases of visual pathways

Healthy control group

Arm Description

Patients with diagnosed glaucoma

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

Patients with optic neuropathies that do not look glaucomatous-like

Patients with diagnosed age-related macular degeneration

Patients with other retinal degenerations excluding AMD

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

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

Outcomes

Primary Outcome Measures

Visual impairment measured by a composite of scores
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.
Proportion of eyes showing progression
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.
Time to detect progression
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

Predictive ability to detect progression (c-index)
The ability of home-based BCI testing to predict future progression on standard automated perimetry will be assessed by the c-index.
Ability to predict changes in patient-reported quality of life (c-index)
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.

Full Information

First Posted
October 19, 2017
Last Updated
January 19, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03318549
Brief Title
Evaluation of Visual and Task Performance
Official Title
Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma
Arm Type
Other
Arm Description
Patients with diagnosed glaucoma
Arm Title
Suspicious of having glaucoma
Arm Type
Other
Arm Description
Patients with suspicious of having glaucoma based on intra-ocular pressure or optic nerve photographs with glaucoma appearance
Arm Title
Non-glaucomatous optic neuropathies;
Arm Type
Other
Arm Description
Patients with optic neuropathies that do not look glaucomatous-like
Arm Title
Age-related macular degeneration (AMD)
Arm Type
Other
Arm Description
Patients with diagnosed age-related macular degeneration
Arm Title
Retinal degenerations
Arm Type
Other
Arm Description
Patients with other retinal degenerations excluding AMD
Arm Title
Other diseases of visual pathways
Arm Type
Other
Arm Description
Other diseases of the visual pathway not included in the previous groups
Arm Title
Healthy control group
Arm Type
Other
Arm Description
Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual Performance tests
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Brain-computer interface for assessment of multifocal steady-state visual evoked potentials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual impairment measured by a composite of scores
Description
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.
Time Frame
5 years
Title
Proportion of eyes showing progression
Description
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.
Time Frame
5 years
Title
Time to detect progression
Description
The time to detect progression will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Predictive ability to detect progression (c-index)
Description
The ability of home-based BCI testing to predict future progression on standard automated perimetry will be assessed by the c-index.
Time Frame
5 years
Title
Ability to predict changes in patient-reported quality of life (c-index)
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe A Medeiros, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Tseng, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Visual and Task Performance

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