Instrument for Glaucoma Early Detection and Monitoring - Full Text View

Instrument for Glaucoma Early Detection and Monitoring (IGDM)

This study is not yet open for participant recruitment.
Verified by Synabridge Corporation, December 2007

Sponsors and Collaborators:	Synabridge Corporation Yale University Columbia University University of Alabama at Birmingham University of Tennessee
Information provided by:	Synabridge Corporation
ClinicalTrials.gov Identifier:	NCT00578110

Purpose

To introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma.

Condition	Intervention
Glaucoma	Device: Glaucoma Diagnosis, Name: Neucodia

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

Official Title:	SBIR II Instrument for Glaucoma Early Detection and Monitoring

Further study details as provided by Synabridge Corporation:

Primary Outcome Measures:

sensitivity and specificity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

repeatability [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental Glaucoma Patients	Device: Glaucoma Diagnosis, Name: Neucodia Sensitivity and Specificity
2: Experimental Glaucoma suspects	Device: Glaucoma Diagnosis, Name: Neucodia Sensitivity and Specificity
3: Active Comparator Controls	Device: Glaucoma Diagnosis, Name: Neucodia Sensitivity and Specificity

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: 40 - 70 years old
Visual acuity: 20/30 or better

Exclusion Criteria:

Eye disease other than glaucoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578110

Contacts


Contact: George Hu, Ph.D.	(908) 725-5213	georgehu@synabridge.com

Contact: Vance Zemon, Ph.D.	(845) 627-0320	vepman@aol.com

Locations


United States, Connecticut
	Yale Eye Center	Not yet recruiting
	New Haven, Connecticut, United States, 06510
	Contact: Ann Leone 203-785-6150 ann.leone@yale.edu
	Principal Investigator: James C Tsai, M.D. MBA

United States, New Jersey
	Synabridge Corp.	Active, not recruiting
	Raritan, New Jersey, United States, 08869

Sponsors and Collaborators

Synabridge Corporation

Yale University

Columbia University

University of Alabama at Birmingham

University of Tennessee

Investigators


Principal Investigator:	George Hu, Ph.D.	Synabridge Corp.

Principal Investigator:	James Tsai, M.D.	Yale University

Study Director:	Max Forbes, M.D.	Columbia University

Study Director:	Vivienne Greenstein, Ph.D.	Columbia University

Principal Investigator:	Eugenue Hartmann, Ph.D.	University of Alabama at Birmingham

Principal Investigator:	Peter Netland, M.D. Ph.D.	University of Tennessee

Study Director:	Leo Pau Semes, O.D.	University of Alabama at Birmingham

Study Director:	Vance M Zemon, Ph.D.	Yeshiva University

More Information

Responsible Party:	Synabridge Corp. ( George Hu, President )
Study ID Numbers:	OPTH_DEV_GLAU_02, 1R43EY015015-01, 1R43EY015015-02
First Received:	December 11, 2007
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00578110
Health Authority:	United States: Institutional Review Board

Keywords provided by Synabridge Corporation:

glaucoma VEP detection device diagnosis vision

Study placed in the following topic categories:

Glaucoma

Eye Diseases

Hypertension

Ocular Hypertension

ClinicalTrials.gov processed this record on October 10, 2008