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Evaluation of Visual and Task Performance

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ClinicalTrials.gov Identifier: NCT03318549
Recruitment Status : Enrolling by invitation
First Posted : October 24, 2017
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment
Glaucoma Macular Degeneration Glaucoma Suspect Optic Neuropathy Retinal Degeneration Visual Pathway Disorder Diagnostic Test: Visual Performance tests

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022


Group/Cohort Intervention/treatment
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.

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.

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.

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.

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 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.

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.




Primary Outcome Measures :
  1. Visual impairment measured by a composite of scores [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Glaucomatous patients who have at least two consecutive abnormal and reliable standard automated perimetry (SAP). Patients considered suspects for glaucoma must have an IOP greater than 21mmHg or suspicious appearance of the optic nerve head but with reliable normal visual fields, defined as a PSD within 95% confidence limits and a GHT result within normal limits. To be considered healthy, subjects have to have IOP<22mmHg with no history of elevated IOP and with at least two reliable normal visual fields, defined as a PSD within 95% confidence limits and a GHT result within normal limits. Age related macular degeneration will be classified if presence of sings of the disease on posterior biomicroscopy (fundoscopy), indirect ophthalmoscopy or Optical Coherence Tomography (OCT) exams. Other retinal degenerations such as retinitis pigmentosa or with other diseases affecting the visual pathways such as ischemic neuropathy or optic neuritis may also be included.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318549


Locations
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United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Felipe A Medeiros, MD, PhD Duke University
Principal Investigator: Henry Tseng, MD, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03318549     History of Changes
Other Study ID Numbers: Pro00088016
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
virtual reality
glaucoma
age related macular degeneration
quality of life
visual field
optical coherence tomography

Additional relevant MeSH terms:
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Optic Nerve Diseases
Optic Neuritis
Ocular Hypertension
Eye Diseases
Eye Diseases, Hereditary
Glaucoma
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Cranial Nerve Diseases
Nervous System Diseases