Trial Outcomes & Findings for How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma? (NCT NCT02622178)
NCT ID: NCT02622178
Last Updated: 2018-11-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
1 examination, one hour
Results posted on
2018-11-15
Participant Flow
Glaucoma patients, suspects and healthy subjects were recruited between 2011 and 2012 in the Glaucoma Service at Wills Eye Hospital, Philadelphia, Pennsylvania, USA.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
49
|
|
Overall Study
COMPLETED
|
42
|
45
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?
Baseline characteristics by cohort
| Measure |
Healthy Subjects
n=42 Participants
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
|
Glaucoma Suspects
n=45 Participants
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
|
Glaucoma Patients
n=49 Participants
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
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
49 participants
n=5 Participants
|
136 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 examination, one hourPopulation: measurement is amplitude in microvolts (uV), the peak strength of the signal, when presented with low contrast stimuli
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.
Outcome measures
| Measure |
Healthy Subjects
n=42 Participants
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.
|
Glaucoma Suspects
n=45 Participants
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.
|
Glaucoma Patients
n=49 Participants
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.
|
|---|---|---|---|
|
Visual Evoked Potential (VEP)
|
6.7 microvolts (uV) (amplitude)
Standard Deviation 3.3
|
7.1 microvolts (uV) (amplitude)
Standard Deviation 3.9
|
4.1 microvolts (uV) (amplitude)
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 1 examination, one hourOptical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.
Outcome measures
| Measure |
Healthy Subjects
n=42 Participants
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.
|
Glaucoma Suspects
n=45 Participants
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.
|
Glaucoma Patients
n=49 Participants
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.
|
|---|---|---|---|
|
Retinal Nerve Fiber Layer Thickness
|
95.1 microns (thickness)
Standard Deviation 8.7
|
87.5 microns (thickness)
Standard Deviation 13.4
|
71.2 microns (thickness)
Standard Deviation 12.1
|
Adverse Events
Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Suspects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. L. Jay Katz
Wills Eye Hospital, Glaucoma Research Center
Phone: 215-928-3123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place