Start of the Clinical trials
Mercredi 9 décembre 2009 - News EyeTechCare
The entrance to clinical phase is going to allow EyeTechCare to start the first clinical study which will be realized on human patients with the EYEOP1 device. The AFSSAPS (French Ministry of Health) authorized the study on examination of the proposed study protocol, as well as the Ethic Committee
This clinical study will allow EYEOP1 to bring the proof of its tolerance and its efficiency within the framework of the treatment of the refractory glaucoma with a ring shaped HIFU device.
The pilot study will be intended for severely affected patients and having already benefited from numerous treatments, in particular surgical, having failed.
The following studies will be intended for patients less severely reached affected.
The clinical phase will end with the obtaining of the CE mark, which will allow EyeTechCare to launch on the market its device.