Clinical Trial

Bionode System in Elevated Intraocular Pressure Patients

Study Description

Clinical Study Of The Bionode System In Subjects With Elevated IOP

The primary objective of this study is to evaluate the safety and effectiveness of the Bionode IOP lowering system in eyes with elevated IOP. The contact lens being studied is similar to an ordinary contact lens that is worn to correct nearsightedness. But the study contact lens has been designed with a thin gold coil around the outside edge of the lens. This design helps deliver a low amount of energy to the eye, which is expected to help lower the pressure inside of the eye. The study contact lens is activated by a pair of glasses (Bionode spectacles) that you wear to apply the treatment to your eye. The study contact lens is only activated when the study glasses are activated.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - Bionode IOP Lowering System

Patients wearing Bionode spectacles and customized contact lens and will receive stimulation at 50 Hz, 100 µs, up to 150 µA for 2 hours.

Device - Bionode IOP Lowering System

Control: No stimulation

Additional Information

Official Study Title

Clinical Study Of The Bionode System In Subjects With Elevated Intraocular Pressure (IOP)

Clinical Trial ID

NCT04093089

ParticipAid ID

epYANa