Several months ago, I highlighted the Triggerfish® “smart” contact lens and a prototype implantable microchip, two devices that demonstrate exceptional promise in measuring and monitoring intraocular (i.e., within the eye) pressure that characterizes the most common types of glaucoma. Thus, I was pleased to learn that two new clinical trials for the Triggerfish lens were about to be launched at the University of California, San Diego Shiley Eye Center.
Clinical Trial Update
These latest clinical trials, entitled SENSIMED Triggerfish Safety and Tolerability and Efficacy of 24-hour Intraocular Pressure Fluctuation Recording with the SENSIMED Triggerfish Contact Lens Sensor are the first Triggerfish trials to be conducted in the United States. Prior trials/studies have been conducted in Canada, Germany, Switzerland, and Belgium.
The purpose of the Triggerfish Safety and Tolerability trial is to evaluate the level of comfort/discomfort in the study eye after wearing the Triggerfish lens for a 24-hour period, in addition to documenting any side effects.
The purpose of the 24-hour Intraocular Pressure Fluctuation trial is to evaluate the safety and effectiveness of the Triggerfish lens in recording accurate fluctuations in intraocular pressure.
About the Triggerfish® “Smart” Contact Lens
The Triggerfish Sensor (pictured above) is a soft hydrophilic (i.e., a substance that attracts water) contact lens that continuously monitors eye pressure in glaucoma. It was developed by SENSIMED, a Swiss technology company that designs and develops micro-systems for medical devices.
The Triggerfish lens is a sensor that monitors changes in the curvature of the cornea, the transparent dome-shaped, or curved, membrane that covers the front surface of the eye. According to SENSIMED, these changes in the cornea correspond directly to fluctuations in intraocular pressure, which is characteristic of certain types of glaucoma.
Eye pressure data from the Triggerfish lens is transmitted wirelessly to a small adhesive antenna, which is placed on the face near the eye. The antenna then transmits the data to a portable recorder worn by the patient. The lens can be worn continuously for one 24-hour period.
When the patient returns to his or her eye doctor, the data is transferred from the recorder to the doctor’s computer via Bluetooth technology for immediate analysis. Data provided by the Triggerfish lens allows eye care practitioners to observe peaks in patients’ eye pressure, which can vary throughout the day. This information can help optimize the type, dosage, and timing of glaucoma medications to better control intraocular pressure.
What the Triggerfish® Lens Can Do
From a University of California, San Diego Health System news release:
Doctors can slow or prevent the progression of glaucoma by reducing [intraocular pressure] with drugs, but their working knowledge of their patients’ conditions traditionally has been limited to an occasional pressure reading obtained during an office visit.
“It’s a snapshot in time,” said Robert N. Weinreb, MD, chair of the department of ophthalmology at the UC San Diego School of Medicine and director of the Hamilton Glaucoma Center at UC San Diego. “Current treatments are based on these one-time readings even though they provide limited information.”
But recent research … shows that intraocular pressure rises and falls throughout the day and night. It is often lowest during waking hours when doctors typically see patients, and highest at night when patients are usually asleep.
“It’s the difference between seeing a single movie frame and watching a full-length motion picture,” Dr. Weinreb said. “With more information, we better understand what is happening to the eye. We can detect changing conditions more quickly. We can adjust or alter treatments more effectively.”
SENSIMED officials are seeking approval from the U.S. Food and Drug Administration by the end of this year. VisionAware will provide updates on this important glaucoma research as they become available.