The EndoArt® is intended to be used as an endothelial prosthesis in patients with chronic corneal edema.The EndoArt® (Artificial Endothelial layer) is a permanent implant, constructed of a clear, transparent, foldable, biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate. The peripheral surface of the EndoArt® has either one or more marks, to ensure the correct orientation of the implant. The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer. Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity. The EndoArt® device is CE marked approved (approved for marketing by the European regulatory authority).
This study is a prospective, multicenter, open-label, phase 2 clinical investigation assessing safety of EndoArt® implantation, in subjects with chronic corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects throughout the study period. Exploratory efficacy endpoints will be assessed by measuring the change in corneal thickness from baseline, change in pain score from baseline and changes in visual acuity. Time to, and rate of, post-surgical rebubbling to facilitate adhesion of the device will be explored. Subjects with chronic corneal edema that meet the inclusion/exclusion criteria will be the study target population. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule. For the Primary endpoint, the frequency and severity of device related adverse events, from patient entry through the 6-month follow-up period will be analyzed. Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months. This clinical investigation is conducted in up to 12 (twelve) clinical sites in Europe (Germany, France, and Netherlands), Mexico, India and Israel. Additional sites may be considered. This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt® as part of its clinical follow up program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
52
Implantation of EndoArt® is similar to other anterior segment surgical procedures such as DSAEK/DMEK.
Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)
Brest, France
Hôpital Fondation A. de Rothschild
Paris, France
Akhali Mzera Eye Clinic
Tbilisi, Georgia
Caucasus Medical Center (CMC)
Tbilisi, Georgia
Davinci Eye Medical Center
Tbilisi, Georgia
High Technology Medical Center, University Clinic
Tbilisi, Georgia
International Vision Correction Research Centre (IVCRC) Universitätsklinikum Heidelberg
Heidelberg, Germany
Dr Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, India
L V Prasad Eye Institute
Hyderabad, Telangana, India
Rambam Medical Center
Haifa, Israel
...and 2 more locations
The frequency of device related adverse events (safety)
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Time frame: 12 months
The severity of device related adverse events (safety).
Adverse events will be assessed on a continuous basis from baseline until follow-ups completion.
Time frame: 12 months
Change from baseline in central corneal thickness (CCT) postoperatively.
Central Corneal Thickness (pachymetry) will be measured by anterior segment Optical Coherence Tomography (OCT).
Time frame: 6 months
Incidence of primary post-surgical detachment of the device.
Post implantation device detachment
Time frame: 12 months
Rate of rebubbling post-op.
Number of times that post implantation re-bubbling is done
Time frame: 12 months
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline.
Visual acuity will be measured with ETDRS format charts.
Time frame: 12 months
Change in ocular pain score as assessed by a Visual Analogue Scale (VAS) from baseline.
VAS is a horizontal line, 0-100 mm. VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the subject marks.
Time frame: 12 months
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