NIDEK Gonioscope GS-1 for Glaucoma

Study Overview
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Brief Summary
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The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. This study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured images, the glaucoma diagnosis and post-operative observation are enabled.

Official Title
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NIDEK Gonioscope GS-1 for Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Other: NIDEK Gonioscope GS-1
* Other: Standard Digital Gonioscopic Images


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with glaucoma or glaucoma suspect Glaucoma Suspect Glaucomatous optic neuropathy as described in the glaucoma patients below AND/OR ocular hypertension (IOP > 21 mm Hg) Normal visual field Glaucoma Patients Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests. Both eyes will be included, except in cases where only one eye meets study criteria Exclusion Criteria: Corneal opacities (scars, edema, etc.) Pregnant or planning to become pregnant Inability to fixate gaze

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucoma & Glaucoma Suspect Patients<br>Patients with Glaucomatous optic neuropathy | Other: NIDEK Gonioscope GS-1<br>* To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.<br>Other: Standard Digital Gonioscopic Images<br>* To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Observer Repeatability for NIDEK Gonioscope GS-1 | To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide. | 1 Day | 
| Inter-Observer Repeatability for Standard Digital Gonioscopic images | To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide. | 1 Day |