Instrument for Glaucoma Early Detection and Monitoring
IGDM
SBIR II Instrument for Glaucoma Early Detection and Monitoring
4 other identifiers
interventional
180
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 20, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 2, 2010
April 1, 2010
2.2 years
December 11, 2007
April 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity
one year
Secondary Outcomes (1)
repeatability
one year
Study Arms (3)
Group 1
EXPERIMENTALGlaucoma Patients
Group 2
EXPERIMENTALGlaucoma suspects
Group 3
ACTIVE COMPARATORControls
Interventions
Sensitivity and Specificity
Eligibility Criteria
You may qualify if:
- Age: 40 - 75 years old
- Visual acuity: 20/30 or better
You may not qualify if:
- Eye disease other than glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Synabridge Corporationlead
- Yale Universitycollaborator
- University of Alabama at Birminghamcollaborator
- University of Tennesseecollaborator
Study Sites (5)
School of Optometry, University of Alabama at Birmingham
Birmingham, Alabama, 35294-0010, United States
Yale Eye Center, Yale University
New Haven, Connecticut, 06510, United States
Synabridge Corp.
Raritan, New Jersey, 08869, United States
Edward S. Harkness Eye Institute, Columbia University
New York, New York, 10032, United States
Hamilton Eye Institute, The University of Tennessee
Memphis, Tennessee, 38103-3452, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
- PRINCIPAL INVESTIGATOR
Sarwat Salim, MD
University of Tennessee
- STUDY DIRECTOR
Mark Swanson, OD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 20, 2007
Study Start
January 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 2, 2010
Record last verified: 2010-04