Implandata Ophthalmic Products GmbH (Implandata) reports the successful implantation of the first patient within the ARGOS-02 clinical study at Augenklinik Bellevue in Kiel, Germany. In the ARGOS-02 clinical study, six eye centers in Germany are currently recruiting primary open angle glaucoma patients, undergoing cataract extraction. These patients are eligible to receive the implantable micro sensor for wireless intraocular pressure measurement.
During cataract surgery Implandata’s intraocular pressure sensor is placed in front of the artificial intraocular lens, posterior to the iris. After implantation of the micro sensor the patient’s intraocular pressure measurements can be measured at any chosen frequency, either continuously over the course of 24 hours or on demand at certain times. Patients can perform measurements by themselves and under normal live conditions. Collected data will be sent via a mobile phone module to the eye doctor’s computer screen, allowing him to remotely monitor and manage the patient’s disease.
“So far the first results of this innovative product are very compelling“, concludes Prof. Dr. med. Detlef Uthoff, Medical Director of Augenklinik Bellevue. “Up to date, early diagnosis and therapeutic management of the disease have been rather dissatisfying for eye doctors. But this innovation allows us for the first time to personalize and control therapy according to the specific needs of the glaucoma patient”, explains Prof. Uthoff.
Implandata’s intraocular pressure sensor allows close monitoring of the patients disease status and glaucoma therapy success. Through simple and more frequent measurements of intraocular pressure – which is the key parameter in glaucoma therapy – important information on therapy response is delivered to the eye doctor early on, enabling immediate glaucoma therapy adjustment, contributing to prevention of further vision loss due to uncontrolled intraocular pressure.
In the ongoing ARGOS-02 study Implandata will generate sufficient data to approach the CE conformity process for intraocular placement of the micro sensor in 2015. Currently the product is not CE marked or FDA approved. But Implandata is planning to conduct in foreseeable future additional clinical studies in Europe and the USA in order to validate various product versions for various glaucoma patient situations.