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

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University of Miami

Status

Completed

Conditions

Visual Pathway Disorder
Macular Degeneration
Retinal Degeneration
Optic Neuropathy
Glaucoma
Glaucoma Suspect

Treatments

Diagnostic Test: Visual Performance tests
Device: Brain-computer interface

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03318549
R01EY029885 (U.S. NIH Grant/Contract)
20240020
Pro00088016

Details and patient eligibility

About

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.

Enrollment

115 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

115 participants in 7 patient groups

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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