Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma.
The FDA approval means that the company based in Lausanne, Switzerland will be able introduce the company’s Triggerfish continuous eye volume monitoring system in the US market.
Triggerfish allows physicians to decide when is the best time to measure the intraocular pressure that changes throughout the day and single in-office tests may not be at all indicative of the actual changes going on inside the eye. The technology should allow for earlier detection of glaucoma before symptoms become apparent.
The system relies on an electronic contact lens that has a sensor built-in that detects fluctuations in the shape of the lens. A special antenna attached around the eye powers and communicates with the contact lens, grabbing readings that are then passed to a portable data recorder.
The system is worn for up to 24 hours and the gathered data is transferred wirelessly using Bluetooth to the physician’s PC for review.
The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye 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 Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “This information can help determine the most critical time of day for the clinician to measure the patient’s IOP.”
Glaucoma is a leading cause of vision loss and affects an estimated three million Americans. Many patients have no symptoms until significant vision has been lost, and this loss is irreversible. IOP varies throughout the day and may not be abnormally high when the patient is at an eye care professional’s office having an eye exam. For example, it is common for IOP to increase during sleep when the patient is lying down.
The Triggerfish device is indicated for use in adults age 22 and older under the direction and supervision of a health care professional. Clinical data supporting the marketing authorization of the Triggerfish included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurement. The effectiveness of the device was demonstrated by showing an association between the Triggerfish device output and IOP fluctuation. The most common temporary side effects were pressure marks from the contact lens, ocular hyperemia (red eyes) and punctate keratitis (irritation of the cornea).
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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