The US Food and Drug Administration (FDA) has approved the Triggerfish (Sensimed AG) contact lens sensor that provides an automated recording of continuous eye pressure changes over the course of 24 hours.
"The Triggerfish gives the clinician 24-hour continuous monitoring of changes in [intraocular pressure (IOP)] patterns that otherwise could not be obtained," William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a news release. "This information can help determine the most critical time of day for the clinician to measure the patient's IOP."
Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma, the FDA notes.
Glaucoma affects an estimated 3 million Americans and is a leading cause of vision loss. Many patients have no symptoms until significant vision has been lost. IOP varies throughout the day and may not be abnormally high during an eye examination. Often, IOP increases during periods of sleep, the FDA says.
The Triggerfish is a single-use soft silicone contact lens embedded with a microsensor that captures spontaneous circumferential changes at the corneoscleral area, the company explains on their website.
The patient wears the contact lens up to 24 hours and assumes normal activities, including sleep. Data from the sensor are transmitted wirelessly to an adhesive antenna worn around the eye. A portable data recorder worn by the patient collects the information and transfers it via Bluetooth to the clinician's computer, which shows the range of time during the day the eye pressure may be increasing.
"The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision," the FDA notes.
The Triggerfish is indicated for use in adults aged 22 years and older under the direction and supervision of a healthcare professional. The Triggerfish contact lens is placed and removed by a healthcare professional.
The approval of the Triggerfish contact lens was based on several studies supporting the safety, tolerability, and effectiveness of the lens, the FDA says. The most common temporary adverse effects were pressure marks from the contact lens, ocular hyperemia, and punctate keratitis.
The FDA reviewed the data for the Triggerfish through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.
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Cite this: FDA Clears New Contact Lens That Senses Eye Pressure Changes - Medscape - Mar 07, 2016.