Instrument for Glaucoma Early Detection and Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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SBIR II Instrument for Glaucoma Early Detection and Monitoring

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Glaucoma Diagnosis, Name: Neucodia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 40 - 75 years old Visual acuity: 20/30 or better Exclusion Criteria: Eye disease other than glaucoma

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Glaucoma Patients | Device: Glaucoma Diagnosis, Name: Neucodia<br>* Sensitivity and Specificity<br>* Other names: NEUCODIA;|
| Experimental: Group 2<br>Glaucoma suspects | Device: Glaucoma Diagnosis, Name: Neucodia<br>* Sensitivity and Specificity<br>* Other names: NEUCODIA;|
| Active Comparator: Group 3<br>Controls | Device: Glaucoma Diagnosis, Name: Neucodia<br>* Sensitivity and Specificity<br>* Other names: NEUCODIA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repeatability |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma VEP detection device diagnosis vision