Endoart - Artificial Lamellar Implant For The Treatment Of Chronic Corneal Edema

To report the interim results of an artificial lamellar implantation (EndoArt®) for the treatment of chronic corneal edema.

A multi-center, international clinical trial was conducted in Israel, the Netherlands, Spain, Germany, Spain and Georgia to evaluate the safety and efficacy of the EndoArt® device for treating chronic corneal edema. The study was non-randomized, open-label, and prospective, and adhered to the Declaration of Helsinki. Each center's institutional review board approved the study prospectively, and patients who met the inclusion criteria and provided informed consent were enrolled.

64 patients with chronic corneal edema underwent EndoArt® implantation. The EndoArt® functions as a water-impermeable barrier, attached to the posterior cornea to prevent inflow of aqueous humor and decrease edema. The first in human (FIH) trial consisted of 22 patients, and an additional 42 patients participated in the second phase study (phase II). Both studies were conducted as part of multi-center international clinical studies and both safety and efficacy parameters were collected and analysed.

Clinically significant improvements were observed in the mean values of all main parameters, including central corneal thickness, best corrected visual acuity, clarity, and pain. Mean initial corneal thickness in the involved eye before surgery (n=56) was 741±114μm (ranging between 603µm and 1087μm) which improved to 551±130μm at 6 months (n=55, FIH and phase II) and to 612±144µm at 12 month (n=16, FIH only). Despite relatively low visual potential, in 64% of patients BCVA improved in at least 3 lines at 12 months (n=11) , best visual acuity result  reached 6/7.5 (n=2).  There were no long-term complications, nor reports of infections or inflammation related to EndoArt® implantation.

The EndoArt® implant was found to be a safe option for patients with chronic corneal edema with good potential efficacy especially in patient who are at high risk for human tissue failure. No side effects were observed, corneal edema and opacity were alleviated in most patients during the follow up.