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Completed

NCT Number: NCT03715231

NIDEK Gonioscope GS-1 for Glaucoma

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIDEK Gonioscope GS-1

Other

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

Other

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.

Primary outcomes

  1. Inter-Observer Repeatability for NIDEK Gonioscope GS-1

    Time frame: 1 Day

    To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.

  2. Inter-Observer Repeatability for Standard Digital Gonioscopic images

    Time frame: 1 Day

    To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2018
Registry last updated
Dec 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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