How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
NCT ID: NCT02622178
Last Updated: 2018-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2011-09-30
2013-12-31
Brief Summary
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Detailed Description
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Hypotheses is that NOVA-DN VEP protocol and Corda analysis results in a high sensitivity, specificity and area under the Receiver Operating Characteristic (ROC) curves (ROC area) for glaucoma detection. Second hypothesis is NOVA-DN VEP protocol and Corda parameters can differentiate between normal and glaucoma suspects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Healthy Subjects
42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal appearing optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Optical Coherence Tomography
Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.
Visual evoked potential
Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
Glaucoma Suspects
45 Glaucoma suspects with glaucomatous appearance optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology (RNFL thickness) and normal visual field results in both eyes. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Optical Coherence Tomography
Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.
Visual evoked potential
Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
Glaucoma Patients
49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc appearance (those with cup to disc ratio greater than 0.7, rim thinning or Retinal Nerve Fiber Layer defects indicative of glaucoma) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye. Participants will have optical coherence tomography (OCT) and Diopsys visual evoked potential testing (VEP).
Optical Coherence Tomography
Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.
Visual evoked potential
Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
Interventions
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Optical Coherence Tomography
Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.
Visual evoked potential
Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* intraocular pressure less than 22 millimeters of mercury (mmHg)
* normal appearing optic discs and retinal nerve fiber layer (RNFL)
* normal optical coherence tomography (OCT) RNFL thickness
* normal visual field (VF) results in both eyes.
Group 2: Glaucoma Suspects
* glaucomatous appearance of optic discs and/or RNFL in at least one eye
* normal OCT
* normal VF results in both eyes.
Group3: Glaucoma Patients
* Glaucomatous optic disc appearance (cup to disc ratio, rim thinning or RNFL defects)
* Repeatable intraocular pressure (IOP) of 23 mmHg or more, in at least one eye
* Repeatable abnormal VF tests
Exclusion Criteria
* visual acuity worse than 20/40
* refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder
18 Years
90 Years
ALL
Yes
Sponsors
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Wills Eye
OTHER
Responsible Party
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L. Jay Katz MD
Principal Investigator
Principal Investigators
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L J Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Locations
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Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Waisbourd M, Gensure RH, Aminlari A, Shah SB, Khanna N, Sood N, Molineaux J, Gonzalez A, Myers JS, Katz LJ. Short-duration transient visual evoked potentials and color reflectivity discretization analysis in glaucoma patients and suspects. Int J Ophthalmol. 2017 Feb 18;10(2):254-261. doi: 10.18240/ijo.2017.02.12. eCollection 2017.
Other Identifiers
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11-125E
Identifier Type: -
Identifier Source: org_study_id
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