NIDEK Gonioscope GS-1 for Glaucoma

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Other: NIDEK Gonioscope GS-1; Other: Standard Digital Gonioscopic Images

• Registration Number: NCT03715231
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2019-06-12
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

• Corneal opacities (scars, edema, etc.)
• Pregnant or planning to become pregnant
• Inability to fixate gaze

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma & Glaucoma Suspect Patients	Standard Digital Gonioscopic Images	Patients with Glaucomatous optic neuropathy
Glaucoma & Glaucoma Suspect Patients	NIDEK Gonioscope GS-1	Patients with Glaucomatous optic neuropathy

Primary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States