Implandata Ophthalmic Products Successfully Completes Clinical Pilot Study for 24h Intraocular Pressure Sensor at Glaucoma Patients
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|Friday, 10 January 2014 10:00 (UTC + 1)|
Hannover, Germany, January 10, 2014 / B3C newswire / -Implandata Ophthalmic Products GmbH (Implandata) has successfully completed its ARGOS-01 pilot study for the first implantable, permanent intraocular pressure sensor. Implant safety and functionality has been demonstrated in this study. In addition important information was gained, which will result in new and additional product versions and alternate implantation procedures.
In this first-in-human study important clinical and technical aspects of the new-to-the-world intraocular pressure sensor for glaucoma patients have been tested and assessed. The micro 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 him to adjust therapy immediately, when necessary, preventing further vision loss due to increased intraocular pressure. Patients can perform measurements with ease by themselves at home and under normal life conditions, by which therapy adherence is expected to be improved for many patients.
“This is a major technology milestone and clinical breakthrough” states Professor Robert N. Weinreb, Distinguished Professor of Ophthalmology at Hamilton Glaucoma Center and Director of Shiley Eye Centers at University San Diego, CA, USA, who is also providing scientific advice to Implandata. Professor Weinreb explains: „Glaucoma clinicians and researchers from all over the world are eagerly waiting since decades for applicable technologies to continuously measure real intraocular pressure. And apparently this technology is now available. This will lead to more efficient management and improved therapy of glaucoma patients.” In addition, the availability of the Implandata technology will represent the starting point to find answers to fundamental, currently unanswered questions, such as what specific pressure situation are responsible for progression of glaucoma and how therapy can be adjusted accordingly, is Professor Weinreb commenting.
Within the ARGOS-01 study, six glaucoma patients have been implanted with the micro sensor for intraocular pressure measurement at University Eye Clinic in Aachen/Germany. Over the course of 12 months tolerance of the implant and functionality has been monitored. Only limited product related issues have been observed which were addressed by a minor design optimization of the implant. The sensor implants have performed properly at any time and delivered reliable measurements of intraocular pressure. At the moment Implandata is preparing its multi-centric ARGOS-02 study, which will include a larger number of patients and which has the goal to deliver sufficient data for the CE marking conformity assessment. Further on the company is working on additional product variations, which will go into pre-clinical and clinical testing in the foreseeable future.