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Instrument for Glaucoma Early Detection and Monitoring (IGDM)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glaucoma Diagnosis, Name: Neucodia
Sponsored by
Synabridge Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring glaucoma VEP detection device diagnosis vision

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 40 - 75 years old
  • Visual acuity: 20/30 or better

Exclusion Criteria:

  • Eye disease other than glaucoma

Sites / Locations

  • School of Optometry, University of Alabama at BirminghamRecruiting
  • Yale Eye Center, Yale UniversityRecruiting
  • Synabridge Corp.Recruiting
  • Edward S. Harkness Eye Institute, Columbia University
  • Hamilton Eye Institute, The University of TennesseeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Glaucoma Patients

Glaucoma suspects

Controls

Outcomes

Primary Outcome Measures

sensitivity and specificity

Secondary Outcome Measures

repeatability

Full Information

First Posted
December 11, 2007
Last Updated
April 1, 2010
Sponsor
Synabridge Corporation
Collaborators
Yale University, University of Alabama at Birmingham, University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT00578110
Brief Title
Instrument for Glaucoma Early Detection and Monitoring
Acronym
IGDM
Official Title
SBIR II Instrument for Glaucoma Early Detection and Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Synabridge Corporation
Collaborators
Yale University, University of Alabama at Birmingham, University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The clinical study will evaluate a novel instrument designed to record visual evoked potentials elicited by stimuli determined in prior research (Greenstein et al., 1998; Badr et al., 2003) to drive select visual pathways that exhibit glaucomatous damage in an efficient and automated manner. The results obtained with this novel device will be compared with results obtained using an existing commercial device. Statistical results, sensitivity and specificity, will be generated for the assessment of the accuracy of the test to discriminate glaucoma patients from controls. Repeatability of the test will also be analyzed based on the test-retest results. Visual evoked potential (VEP) is a measure of neural function in the eye and brain. Three skin electrodes are placed on the surface of the scalp to record the electrical activity from the brain while the subject is observing a flickering stimulus with isolated-check/dot pattern. The whole procedure is non-invasive and the risks are negligible. Isolated-Check/dot Stimuli of about 10 Hz with luminance contrast of 10%, 15%, -10%, and -15% will be used to test each eye. Eight samples for each stimulus will be recorded. Each experimental run takes 2 seconds. The T-circ statistical method is performed to process the data, and the VEP signal to noise ratio (SNR) is calculated in order to obtain an optimized condition (stimulus and threshold) to separate glaucoma patients and normal group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma VEP detection device diagnosis vision

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Glaucoma Patients
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Glaucoma suspects
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Controls
Intervention Type
Device
Intervention Name(s)
Glaucoma Diagnosis, Name: Neucodia
Other Intervention Name(s)
NEUCODIA
Intervention Description
Sensitivity and Specificity
Primary Outcome Measure Information:
Title
sensitivity and specificity
Time Frame
one year
Secondary Outcome Measure Information:
Title
repeatability
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 40 - 75 years old Visual acuity: 20/30 or better Exclusion Criteria: Eye disease other than glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Hu, Ph.D.
Phone
(908) 725-5213
Email
georgehu@synabridge.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vance Zemon, Ph.D.
Phone
(845) 627-0320
Email
vepman@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hu, Ph.D.
Organizational Affiliation
Synabridge Corp.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Tsai, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Max Forbes, M.D.
Organizational Affiliation
Columbia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vivienne Greenstein, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eugenue Hartmann, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Netland, M.D. Ph.D.
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leo Pau Semes, O.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vance M Zemon, Ph.D.
Organizational Affiliation
Yeshiva University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sarwat Salim, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Swanson, OD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
Facility Information:
Facility Name
School of Optometry, University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naser T Naser
Phone
205-222-4543
Email
dcnaser@uab.edu
First Name & Middle Initial & Last Name & Degree
Eugenie Hartmann, Ph.D.
Phone
205-975-3143
Email
EEHartmann@uab.edu
First Name & Middle Initial & Last Name & Degree
Eugenie Hartmann, Ph.D.
Facility Name
Yale Eye Center, Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Leone
Phone
203-785-6150
Email
ann.leone@yale.edu
First Name & Middle Initial & Last Name & Degree
James C Tsai, M.D. MBA
Facility Name
Synabridge Corp.
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Hu, Ph.D.
Phone
908-725-5213
Email
georgehu@synabridge.com
First Name & Middle Initial & Last Name & Degree
George Hu, Ph.D.
Facility Name
Edward S. Harkness Eye Institute, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Completed
Facility Name
Hamilton Eye Institute, The University of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103-3452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarwat Salim, MD
Phone
901-351-0777
Email
sarwat_salim@yahoo.com
First Name & Middle Initial & Last Name & Degree
George Hu, Ph.D.
Phone
908-803-7040
Email
gehu@verizon.net
First Name & Middle Initial & Last Name & Degree
Peter A Netland, MD, Ph.D.
First Name & Middle Initial & Last Name & Degree
Sarwat Salim, MD

12. IPD Sharing Statement

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Instrument for Glaucoma Early Detection and Monitoring

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