Instrument for Glaucoma Early Detection and Monitoring (IGDM)
Recruitment status was Recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | SBIR II Instrument for Glaucoma Early Detection and Monitoring |
- sensitivity and specificity [ Time Frame: one year ] [ Designated as safety issue: No ]
- repeatability [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Glaucoma Patients
|
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
|
|
Experimental: Group 2
Glaucoma suspects
|
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
|
|
Active Comparator: Group 3
Controls
|
Device: Glaucoma Diagnosis, Name: Neucodia
Sensitivity and Specificity
Other Name: NEUCODIA
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age: 40 - 75 years old
- Visual acuity: 20/30 or better
Exclusion Criteria:
- Eye disease other than glaucoma
Contacts and Locations| Contact: George Hu, Ph.D. | (908) 725-5213 | georgehu@synabridge.com |
| Contact: Vance Zemon, Ph.D. | (845) 627-0320 | vepman@aol.com |
| United States, Alabama | |
| School of Optometry, University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294-0010 | |
| Contact: Naser T Naser 205-222-4543 dcnaser@uab.edu | |
| Contact: Eugenie Hartmann, Ph.D. 205-975-3143 EEHartmann@uab.edu | |
| Principal Investigator: Eugenie Hartmann, Ph.D. | |
| United States, Connecticut | |
| Yale Eye Center, Yale University | 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. | Recruiting |
| Raritan, New Jersey, United States, 08869 | |
| Contact: George Hu, Ph.D. 908-725-5213 georgehu@synabridge.com | |
| Principal Investigator: George Hu, Ph.D. | |
| United States, New York | |
| Edward S. Harkness Eye Institute, Columbia University | Completed |
| New York, New York, United States, 10032 | |
| United States, Tennessee | |
| Hamilton Eye Institute, The University of Tennessee | Recruiting |
| Memphis, Tennessee, United States, 38103-3452 | |
| Contact: Sarwat Salim, MD 901-351-0777 sarwat_salim@yahoo.com | |
| Contact: George Hu, Ph.D. 908-803-7040 gehu@verizon.net | |
| Principal Investigator: Peter A Netland, MD, Ph.D. | |
| Principal Investigator: Sarwat Salim, MD | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | George Hu, President, Synabridge Corp. |
| ClinicalTrials.gov Identifier: | NCT00578110 History of Changes |
| Other Study ID Numbers: | OPTH_DEV_GLAU_02, 1R43EY015015-01, 1R43EY015015-02, 1R43EY015015-03 |
| Study First Received: | December 11, 2007 |
| Last Updated: | April 1, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Synabridge Corporation:
|
glaucoma VEP detection device diagnosis vision |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013