Long Term Outcomes Of A Novel Artificial Endothelial Replacement Membrane

To report long-term safety and efficacy outcomes of an artificial lamellar implantation (EndoArt®) on the posterior surface of the cornea of adult patients suffering from chronic corneal edema.

Eleven of the 24 reported patients were enrolled in a first-in-human (FIH) study, with implantations conducted across multiple centers: Rambam Hospital and Sourasky Hospital in Israel; UMC in the Netherlands; Universitäts-Augenklinik in Germany; and LV Prasad Eye Institute in India. Additionally, 2 compassionate cases were performed at Universitäts-Augenklinik in Germany, and 11 post-market approval cases were conducted at Soroka, Israel and at Alma Mater Studiorum University of Bologna, Italy.

The EndoArt® (EyeYon Medical, Ness Ziona, Israel) is designed as a water-impermeable layer that adheres to the recipient's posterior cornea. This barrier prevents aqueous humour from entering the stroma, thereby reducing corneal edema. Long-term efficacy and safety data from a 24–36-month follow-up of 24 patients is presented. Changes in central corneal thickness (CCT) and best corrected visual acuity (BCVA) are detailed over the follow-up period. Additionally, safety outcomes are thoroughly discussed.

A significant improvement in CCT was observed after a month and remained stable. At the last follow-up, 88% of  patients had at least 15% improvement in CCT. Mean preoperative CCT of 793±104μm improved to 579±84µm and 583±106µm after 24 and 36 months, respectively (n=24/10, respectively, p.value<<0.05). Among 21 patients with visual potential, in 17 vision improved: 10 patients regained at least 8 ETDRS lines at last visit. Three patients reverted to baseline BCVA due to consistent partial detachment. In 1 case the implant was removed and replaced with tissue due to lack of efficacy. No long-term complications, infections or inflammation related to EndoArt® implantation were observed. Implants remained transparent throughout the follow-up.

The EndoArt® implant was found safe and effective, demonstrating an improvement in corneal thickness as well as in visual acuity. Outcomes of 24 early cases, from the beginning of the learning curve reveal that when fully attached, EndoArt® can alleviate corneal edema and maintain a clear and viable cornea over a long-term period.