First-in-human testing of micro-sensor for continuous IOP monitoring

Researchers in Germany have implanted the human eye with a micro-sensor, called Eyemate™, that can continuously monitor IOP in patients with glaucoma. The feat marks the first time the miniature device has been tested in humans.

The sensor can be implanted during cataract, glaucoma or corneal surgery. Patients use a handheld device to obtain IOP measurements and transmit the data to their eye care specialist.

“This opens up the path to proceed forward towards design finalization, expanded clinical validation and regulatory approval,” says Max Ostermeier, CEO of Implandata Ophthalmic Products GmbH, which developed the device.

According to Implandata, the system’s chief advantage is that it measures IOP wherever necessary, and does not require patients to obtain measurements at the doctor’s office.  But the micro-sensor also boasts another advantage: Eyemate requires a surgical incision of < 2.7 mm, far smaller than the 4-mm slit required to place currently available implants.

“Reduction of incision size is one major advancement; easier insertion and positioning of the micro-sensor another benefit. In eye surgery, less invasive methods mean lower risk of surgical or post-surgical complications, resulting in higher surgeons’ acceptance,” says Prof. Burkhard Dick, director of the University Eye Hospital of Bochum, Germany, who carried out the first-in-human validation studies.

The device received the European CE mark of approval in June. Implandata plans to introduce the sensor to European markets in 2018.