Back to resultsHow Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Primary Purpose
Glaucoma Diagnosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography
Visual evoked potential
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma Diagnosis
Eligibility Criteria
Inclusion Criteria:
Group 1: Healthy Subjects
- 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:
- inability to perform reliable VF or OCT
- visual acuity worse than 20/40
- refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder
Sites / Locations
- Wills Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy Subjects
Glaucoma Suspects
Glaucoma Patients
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Retinal Nerve Fiber Layer Thickness
Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02622178
Brief Title
How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Official Title
Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Experimental
Arm Description
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).
Arm Title
Glaucoma Suspects
Arm Type
Experimental
Arm Description
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).
Arm Title
Glaucoma Patients
Arm Type
Experimental
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical Coherence Tomography
Other Intervention Name(s)
OCT
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual evoked potential
Other Intervention Name(s)
VEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Evoked Potential (VEP)
Description
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.
Time Frame
1 examination, one hour
Secondary Outcome Measure Information:
Title
Retinal Nerve Fiber Layer Thickness
Description
Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.
Time Frame
1 examination, one hour
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:
Group 1: Healthy Subjects
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:
inability to perform reliable VF or OCT
visual acuity worse than 20/40
refractive error greater than +/-5.00 diopters sphere, greater than +/- 3.00 diopers cylinder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L J Katz, MD
Organizational Affiliation
Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Manuscript has been published.
Citations:
PubMed Identifier
28251085
Citation
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.
Results Reference
result
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How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
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