NIDEK Gonioscope GS-1 for Glaucoma

Brief description of study

The purpose of this study is to compare a new device called NIDEK Gonioscope GS-1 with the conventional hand-held gonioscope used in clinic today. Gonioscopy involves measuring a structure in the front of the eye called the iridiocorneal angle (angle between the iris and cornea). The NIDEK Gonioscope GS-1 is a machine that automatically measures this angle. In comparison, with the conventional gonioscope, the ophthalmologist must hold a special lens to the eye and look through a slit lamp to observe the same angle. Pictures taken by the NIDEK Gonioscope GS-1 will be compared with the conventional gonioscope to determine if the new gonioscope is accurate. The study team will also be taking images of the angle with a device called an ultrasound biomicroscope. This device uses harmless sound waves to allow us to see how wide the angle is. The study team will use the ultrasound biomicroscope to confirm our evaluation of the angle width. The conventional gonioscope and ultrasound biomicroscope are approved by the US Food and Drug Administration (FDA) for this use. Although the NIDEK GS-1 gonioscope is approved for clinical purposes in other countries, its use in this study is considered investigational because it is not FDA approved.

Clinical Study Identifier: s18-00429 Identifier: NCT03715231

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