Objective of the clinical pilot study

The first clinical pilot study on the EyeOP1 device was completed in March 2011

The pilot study was carried out on a limited number of patients suffering from refractory glaucoma.
 
The first patients were treated at :

• Hôpital de la Croix Rousse in Lyon, Ophthalmology dept., by Prof. Philippe DENIS
• Hôpital Edouard Herriot in Lyon, Ophthalmology dept., Wing C, by Dr. Florent APTEL
• Hôpital des Quinze Vingts in Paris, in the Ophthalmology department of Prof. Jean-Philippe NORDMANN

Objectives

The study had many objectives.  These included confirming the efficacy and tolerance of the new UC³ therapeutic method.
 
Another objective was to confirm the treatment dose.

Safety

This study was approved by the French National Health Regulatory Authority (AFSSAPS). AFSSAPS which, in particular, assesses the safety of the first patients treated, approved the study in light of the preclinical test results which were obtained from the preliminary studies that lasted approximately 2 years and were conducted in collaboration with INSERM.

Results

Results from the pilot study have thus far been presented at :

• the SFO Congress (Société Française d'Ophtalmologie) and the SFG (Société Française du Glaucome) - Paris, France, May 2011
• the ARVO Congress (Association for Research in Vision and Ophthalmology) - Fort Lauderdale FL, USA, May 2011
• the SOE Congress (European Society of Ophthalmology) - Geneva, Switzerland, June 2011
• the WGA Congress (World Glaucoma Association) - Paris, France, June 2011

The results demonstrate the excellent tolerance and very significant efficacy of the treatment.

To access the ARVO poster and view the results of the pilot study, click here

Next steps

Following the pilot study which took place in France, EyeTechCare started implementing a European multicenter study called EyeMUST to collect clinical data from a larger number of patients in many leading centers located throughout Europe. 

To know more about the EyeMUST study, click here

Experimental device under development and clinical investigation. Refer to the medical information in legal notices. 

Discover the EYEOP1 system intended for HIFU treatment of refractory glaucoma