Long Term Outcomes Of A Novel Artificial Endothelial Replacement Membrane
Published 2025 - 43rd Congress of the ESCRS
Reference: PP25.10 | Type: Free paper | DOI: 10.82333/wdpe-r528
Authors: Sergio Manuel Solarino 1 , Claudia Cannas 2 , Valerio Calabresi 2 , Filippo Lixi* 2 , Giorgia Deiana 1 , Roberta Schirru 1 , Giuseppe Giannaccare 2
1Centrovista Eye Clinic,Cagliari,Italy, 2Department of Surgical Sciences,University of Cagliari,Cagliari,Italy
Purpose
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.
Setting
Eight of the 21 reported patients were enrolled in a first-in-human (FIH) study, with implantations conducted at the centers: Rambam Medical Center and Sourasky Medical Center in Israel; UMC in the Netherlands; Universitäts-Augenklinik in Germany; and LV Prasad Eye Institute in India. Additional two 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.
Methods
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-month follow-up of 21 patients. 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.
Results
A significant improvement in CCT was observed after one month and remained stable over 24 months. Mean preoperative CCT of 793±108μm improved to 565±110µm and 577±89µm after 12 and 24 months, respectively (n=21, p.value<<0.05). Among 18 patients with visual potential, 14 experienced improved vision; notably, 10 patients regained at least 7 ETDRS lines at 24 months. Vision improved continuously between 12 and 24 months. Three patients reverted to baseline BCVA due to partial detachment of the device. In one 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.
Conclusions
The EndoArt® implant was found safe and effective, demonstrating an improvement in corneal thickness as well as in visual acuity. Outcomes of 21 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.