Expired Study
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Philadelphia, Pennsylvania 19107


Purpose:

The main goal of this study is to evaluate the sensitivity and specificity of the NOVA-DN VEP protocol and a new software and method (Corda) for the glaucoma detection using optical coherence tomography images. Another objective is to evaluate the sensitivity and specificity of these tests to differentiate between normal subjects and glaucoma suspects. The hypothesis is that the 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 the glaucoma detection. Another hypothesis is that the NOVA-DN VEP protocol and some Corda parameters can differentiate between normal subjects and glaucoma suspects.


Study summary:

The aim of this study is to evaluate the ability of the NOVA-DN VEP protocol and Corda parameters to discriminate between healthy eyes and eyes with early to moderate glaucomatous visual field loss. For this purpose the sensitivity (specificity cutoffs of 85%, 90%, and 95%) and ROC of Corda parameters will be obtained. We will evaluate those measurements of the NOVA-DN VEP protocol, Corda software and the Cirrus SD-OCT software in order to compare and correlate those analyses.


Criteria:

Inclusion Criteria: Group 1: Healthy Subjects - intraocular pressure less than 22 mmHg - normal appearing optic discs and RNFL - normal OCT (RNFL thickness) - normal visual field results in both eyes. Group 2: Glaucoma Suspects - glaucomatous appearance of the optic discs and/or RNFL in at least one eye - normal OCT (RNFL thickness) - normal visual field results in both eyes. Group3: Glaucoma Patients - Repeatable abnormal visual field results - Glaucomatous optic disc appearance (those with cup to disc area ratio, rim thinning or RNFL defects indicative of glaucoma) - Repeatable intraocular pressure of 23 mmHg or more, in at least one eye - Abnormal visual field tests


NCT ID:

NCT02622178


Primary Contact:

Principal Investigator
L J Katz, MD
Wills Eye Hospital


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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