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NIDEK Gonioscope GS-1 for Glaucoma

NIDEK Gonioscope GS-1 for Glaucoma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03715231
Enrollment
24
Registered
2018-10-23
Start date
2019-06-12
Completion date
2021-05-26
Last updated
2021-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

OTHERNIDEK 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.

OTHERStandard 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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inter-Observer Repeatability for NIDEK Gonioscope GS-11 DayTo 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 images1 DayTo determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026