Implandata Ophthalmic Products GmbH (Implandata) and Professor Peter Szurman, Head of “Section Experimental Ophthalmic Surgery” at Eye Hospital of University Tübingen, have started pre-clinical studies for the first implantable, permanent extraocular sensor, measuring intraocular pressure. The primary objective of the study is to show proof of concept and to demonstrate product and procedure safety. It is expected that the studies will provide additional design input, before early feasibility studies are started at human patients.
Whereas the company’s permanent intraocular pressure sensor is implanted at patients with pseudophakic eyes (glaucoma patients who undergo cataract surgery, or where cataract extraction has been done already before), the less invasive extraocular sensor implant measuring intraocular pressure can also address glaucoma patients with phakic eyes with healthy intraocular lenses.
The micro sensor of both versions 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 ophthalmologists early on, enabling immediate glaucoma management adjustment, resulting in prevention of further vision loss due to uncontrolled intraocular pressure. Patients can perform pressure measurements with ease by themselves at home and under normal life conditions.
Study investigator Prof. Peter Szurman explains: “The implantable micro sensor will provide a new dimension in glaucoma monitoring, management and control. Furthermore this device is the next step to personalized glaucoma therapy and will be an effective tool to monitor intraocular pressure even out of medical practice hours and thus help us preventing progression of intraocular pressure-associated optic neuropathy which would further lead to permanent vision damage and blindness.” After the minimal invasive way of implantation the extraocular micro sensor is easy to handle for the health personnel and the patient and is a reliable way to measure intraocular pressure with high precision, comments Prof. Szurman.
After successful completion of the ARGOS-01 early feasibility study, Implandata is currently conducting ARGOS-02 clinical study with its implantable intraocular pressure sensor, with the goal to start the EC Conformity Declaration process in 2015. After completion of the pre-clinical study with the implantable extraocular sensor measuring intraocular pressure by end of 2014, Implandata and Prof. Peter Szurman will decide on next steps towards early feasibility studies of the extraocular placed sensor at glaucoma patients. Overall, Implandata is well underway to significantly broaden its product portfolio for telemetric measurement of intraocular pressure and improved glaucoma management.
