NIDEK Gonioscope GS-1 for Glaucoma

Glaucoma Clinical Trial

Official title:

NIDEK Gonioscope GS-1 for Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715231
• Other study ID #: 18-00429
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: May 26, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Other:
• NIDEK Gonioscope GS-1
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.
• Standard Digital Gonioscopic Images
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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