NIDEK Gonioscope GS-1 for Glaucoma

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03715231

Collaborator

(none)

Enrollment

Location

Arm

23.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Other: NIDEK Gonioscope GS-1 Other: Standard Digital Gonioscopic Images	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

NIDEK Gonioscope GS-1 for Glaucoma

Actual Study Start Date :

Jun 12, 2019

Actual Primary Completion Date :

May 26, 2021

Actual Study Completion Date :

May 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glaucoma & Glaucoma Suspect Patients Patients with Glaucomatous optic neuropathy	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. Other: 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.

Arm

Intervention/Treatment

Experimental: Glaucoma & Glaucoma Suspect Patients

Patients with Glaucomatous optic neuropathy

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.

Other: Standard Digital Gonioscopic Images

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Joel Schuman, NYUMC Langone

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03715231

Other Study ID Numbers:

18-00429

First Posted:

Oct 23, 2018

Last Update Posted:

Dec 30, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Dec 30, 2021