NIDEK Gonioscope GS-1 for Glaucoma

NYU Langone Health

Status: Completed

Conditions: Glaucoma

Treatments: Other: NIDEK Gonioscope GS-1; Other: Standard Digital Gonioscopic Images

Study type: Interventional

Funder types: Other

Identifiers

NCT03715231

18-00429

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Glaucoma & Glaucoma Suspect Patients

Experimental group

Description:

Patients with Glaucomatous optic neuropathy

Treatment:

Other: Standard Digital Gonioscopic Images

Other: NIDEK Gonioscope GS-1