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Evaluate sensitivity and specificity of NOVA-DN visually evoked potentials (VEP) protocol and new software method (Corda) for glaucoma detection using optical coherence tomography (OCT) images to differentiate between normal subjects and glaucoma suspects.
The aim of this study was to evaluate the ability of NOVA-DN VEP protocol and Corda parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous visual field loss. We will evaluate measurements of the NOVA-DN VEP protocol, Corda software and Cirrus spectral domain (SD) OCT software in order to compare and correlate.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Experimental | 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). |
|
| Glaucoma Suspects | Experimental | 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). |
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| Glaucoma Patients | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Evoked Potential (VEP) | Diopsys Visual evoked potential (VEP) (Diopsys, Inc. Pine Brook, NJ) is used to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex. This is the strength of the signal recorded from the back of the head near where vision is processed in the brain while a visual stimulus is presented to patient. | 1 examination, one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Nerve Fiber Layer Thickness | Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns. | 1 examination, one hour |
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Inclusion Criteria:
Group 1: Healthy Subjects
Group 2: Glaucoma Suspects
Group3: Glaucoma Patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L J Katz, MD | Wills Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28251085 | Result | 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. |
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Manuscript has been published.
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Glaucoma patients, suspects and healthy subjects were recruited between 2011 and 2012 in the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania, USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subjects | 42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing. Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD). Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed. |
| FG001 | Glaucoma Suspects | 45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing. Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD). Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed. |
| FG002 | Glaucoma Patients | 49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (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 will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing. Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD). Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subjects | 42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes for optical coherence tomography (OCT) and 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 wit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Evoked Potential (VEP) | Diopsys Visual evoked potential (VEP) (Diopsys, Inc. Pine Brook, NJ) is used to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex. This is the strength of the signal recorded from the back of the head near where vision is processed in the brain while a visual stimulus is presented to patient. | measurement is amplitude in microvolts (uV), the peak strength of the signal, when presented with low contrast stimuli | Posted | Mean | Standard Deviation | microvolts (uV) (amplitude) | 1 examination, one hour |
|
1 examination, one hour
No adverse or serious adverse events were reported during this 1 examination, one hour study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Subjects | 42 Healthy subjects with intraocular pressure less than 22 millimeters of mercury (mmHg), normal optic discs and retinal nerve fiber layer, normal optical coherence technology (RNFL thickness) and normal visual fields in both eyes for optical coherence tomography (OCT) and 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 wit |
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Small sample size. Participants were all recruited from one large urban setting. Age difference between the groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. L. Jay Katz | Wills Eye Hospital, Glaucoma Research Center | 215-928-3123 | ljkatz@willseye.org |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| D005074 | Evoked Potentials, Visual |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
| Visual evoked potential | Diagnostic Test | 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. |
|
|
| BG001 | Glaucoma Suspects | 45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography and visual evoked potential. 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 check |
| BG002 | Glaucoma Patients | 49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (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 will have optical coherence tomography and visual evoked potential. 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 visu |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Glaucoma Suspects | 45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing. Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD). Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed. |
| OG002 | Glaucoma Patients | 49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (cup to disc ratio greater than 0.7, rim thinning or glaucomatous Retinal Nerve Fiber Layer defects) and/or repeatable intra-ocular pressure of 23 mmHg or higher, in at least one eye will have optical coherence tomography (OCT) imaging and visual evoked potential (VEP) testing. Optical coherence tomography (OCT), noninvasive imaging, provides micrometer-scale resolution. It utilizes Fourier domain (FD) techniques, with sensitivity advantage over traditional time domain (TD). Visual evoked potential (VEP) objectively tests visual field by viewing a monitor at 1 meter of square black/white checks with electrodes on back of head where vision is processed. |
|
|
| Secondary | Retinal Nerve Fiber Layer Thickness | Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns. | Posted | Mean | Standard Deviation | microns (thickness) | 1 examination, one hour |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Glaucoma Suspects | 45 Glaucoma suspects with glaucomatous optic discs and/or thin retinal nerve fiber layer in at least one eye, normal optical coherence technology and normal visual field results will have optical coherence tomography and visual evoked potential. 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 check | 0 | 45 | 0 | 45 | 0 | 45 |
| EG002 | Glaucoma Patients | 49 Glaucoma patients with repeatable abnormal visual fields, glaucomatous optic disc (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 will have optical coherence tomography and visual evoked potential. 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 visu | 0 | 49 | 0 | 49 | 0 | 49 |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009799 | Ocular Physiological Phenomena |