GlaucomaIGDMNCT00578110
Instrument for Glaucoma Early Detection and Monitoring
A study testing Glaucoma Diagnosis, Name: Neucodia in people with Glaucoma, run by Synabridge Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Glaucoma Diagnosis, Name: Neucodia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Apr 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 40 - 75 years old
- Visual acuity: 20/30 or better
Who cannot join
- Eye disease other than glaucoma
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
School of Optometry, University of Alabama at Birmingham
Birmingham, Alabama, 35294-0010
Naser T Naser, 205-222-4543, dcnaser@uab.edu
Eugenie Hartmann, Ph.D., 205-975-3143, EEHartmann@uab.edu
- Recruiting
Hamilton Eye Institute, The University of Tennessee
Memphis, Tennessee, 38103-3452
Sarwat Salim, MD, 901-351-0777, sarwat_salim@yahoo.com
George Hu, Ph.D., 908-803-7040, gehu@verizon.net
- Recruiting
Yale Eye Center, Yale University
New Haven, Connecticut, 06510
Ann Leone, 203-785-6150, ann.leone@yale.edu
James C Tsai, M.D. MBA
- Completed
Edward S. Harkness Eye Institute, Columbia University
New York, New York, 10032
- Recruiting
Synabridge Corp.
Raritan, New Jersey, 08869
George Hu, Ph.D., 908-725-5213, georgehu@synabridge.com
George Hu, Ph.D.
About this study
Official title: SBIR II Instrument for Glaucoma Early Detection and Monitoring
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Glaucoma Diagnosis, Name: Neucodia
- Keywords
- glaucoma VEP detection device diagnosis vision
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma Diagnosis, Name: NeucodiaDevice
Also called NEUCODIA
Sensitivity and Specificity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Glaucoma Patients Receives: Device: Glaucoma Diagnosis, Name: Neucodia |
| Group 2 | Experimental | Glaucoma suspects Receives: Device: Glaucoma Diagnosis, Name: Neucodia |
| Group 3 | Active comparator | Controls Receives: Device: Glaucoma Diagnosis, Name: Neucodia |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity
Measured: one year
Secondary outcomes (1)
repeatability
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synabridge Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University, University of Alabama at Birmingham, University of Tennessee
- Investigators
- George Hu, Ph.D., Principal investigator, Synabridge Corp.James Tsai, M.D., Principal investigator, Yale UniversityMax Forbes, M.D., Study director, Columbia UniversityVivienne Greenstein, Ph.D., Study director, Columbia UniversityEugenue Hartmann, Ph.D., Principal investigator, University of Alabama at BirminghamPeter Netland, M.D. Ph.D., Principal investigator, University of TennesseeLeo Pau Semes, O.D., Study director, University of Alabama at BirminghamVance M Zemon, Ph.D., Study director, Yeshiva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578110
- Sponsor's protocol ID
- OPTH_DEV_GLAU_02
- Other IDs
- 1R43EY015015-01, 1R43EY015015-02, 1R43EY015015-03
- Acronym
- IGDM
- Status last verified
- Apr 2010
- First submitted
- 11 Dec 2007
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No