Glaucoma DiagnosisNCT02622178

How Accurately Does the Diopsys Visual Evoked Potential (VEP) Vision Testing System Detect Glaucoma?

A study testing Optical Coherence Tomography and Visual evoked potential in people with Glaucoma Diagnosis, run by Wills Eye at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Glaucoma Diagnosis
What is being tested?: Optical Coherence Tomography and Visual evoked potential
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wills Eye Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis

Read the 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.

Conditions: Glaucoma Diagnosis
Being tested: Optical Coherence Tomography, Visual evoked potential

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optical Coherence TomographyDiagnostic test
Also called OCT
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 potentialDiagnostic test
Also called VEP
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.

Study groups in NCT02622178
Study group	Role	What they receive
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). Receives: Diagnostic Test: Optical Coherence Tomography; Diagnostic Test: Visual evoked potential
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). Receives: Diagnostic Test: Optical Coherence Tomography; Diagnostic Test: Visual evoked potential
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). Receives: Diagnostic Test: Optical Coherence Tomography; Diagnostic Test: Visual evoked potential

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 examination, one hour

Secondary outcomes (1)

Retinal Nerve Fiber Layer Thickness
Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.
Measured: 1 examination, one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Dec 2013

First posted4 Dec 2015 (estimated)
Study startSep 2011
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glaucoma DiagnosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02622178
Sponsor's protocol ID: 11-125E
Status last verified: Oct 2018
First submitted: 6 Aug 2015
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Manuscript has been published.

Publications

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.
PubMed 28251085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma Diagnosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sensitivity and Specificity of the NOVA-DN VEP Protocol and a Novel Analysis of Optical Coherence Tomography Images for Glaucoma Diagnosis
ClinicalTrials.gov ID: NCT02622178
Acronym / sponsor ID: 11-125E
Conditions: Glaucoma Diagnosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Wills EyeUniversity, hospital or other
Study start: Sep 2011 (actual)
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 4 Dec 2015 (estimated)
Results: Posted 15 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Healthy Subjects	Experimental	Diagnostic Test: Optical Coherence Tomography, Diagnostic Test: Visual evoked potential42 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	Diagnostic Test: Optical Coherence Tomography, Diagnostic Test: Visual evoked potential45 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).
Glaucoma Patients	Experimental	Diagnostic Test: Optical Coherence Tomography, Diagnostic Test: Visual evoked potential49 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).

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Optical Coherence TomographyAlso: OCTOptical 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.	Diagnostic test	Glaucoma Patients, Glaucoma Suspects, Healthy Subjects
Visual evoked potentialAlso: VEPVisual 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.	Diagnostic test	Glaucoma Patients, Glaucoma Suspects, Healthy Subjects

Primary outcome

Visual Evoked Potential (VEP)
Time frame: 1 examination, one hour
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 secondary outcome

Retinal Nerve Fiber Layer Thickness
Time frame: 1 examination, one hour

Results and safety

Results posted to the registry on 15 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Subjects	42	42
Glaucoma Suspects	45	45
Glaucoma Patients	49	49

Primary outcome: Visual Evoked Potential (VEP)

Time frame: 1 examination, one hour. Mean (Standard Deviation). Unit: microvolts (uV) (amplitude)

Measure	Healthy Subjects n = 42	Glaucoma Suspects n = 45	Glaucoma Patients n = 49
Value	6.7 (3.3)	7.1 (3.9)	4.1 (2.7)

Population analysed: measurement is amplitude in microvolts (uV), the peak strength of the signal, when presented with low contrast stimuli

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 examination, one hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Subjects	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Glaucoma Suspects	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Glaucoma Patients	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): Small sample size. Participants were all recruited from one large urban setting. Age difference between the groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28251085Waisbourd 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.
Individual participant dataSharing planned: No. Manuscript has been published.

Related trials for Glaucoma Diagnosis

RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

L J Katz, MD principal investigator

Wills Eye Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Optical Coherence Tomography and Visual evoked potential in people with Glaucoma Diagnosis, run by Wills Eye at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Evoked Potential (VEP) (time frame: 1 examination, one hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622178, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.