The Endoart: A Real-World Evidence And Long-Term Results Of 14 Patients.

To report the long-term outcomes of my personal experience in real life implantation of the EndoArt (artificial endothelial keratoprosthesis).

The study was conducted at the Department of Ophthalmology at Soroka University Medical Center, Beer-Sheva, Israel (SUMC), between March 2022 and February 2024. The study was approved by the Institutional Review Board (IRB) of the Ben-Gurion University of the Negev, Israel

A prospective case series of 14 patients with endothelial failure, and poor visual acuity caused by posterior segment pathology, were included. Previous glaucoma or corneal surgery was an exclusion criteria. The outcome measures were implant adherence, safety, and improvement of central corneal thickness on OCT and visual acuity. The principle of  Endoart functions is a mechanical barrier preventing seepage of fluids from the AC into the corneal stroma. 4 patients underwent combined (phacoemulsification with PC IOL and Endoart implantation) surgery.

The EndoArt device was implanted in 14 patients (10 with Bullous Keratopathy and 4 with Fuchs dystrophy).  Follow-up time ranges were from 18 to 24 months.

The central cornea thickness was significantly reduced by 36%, from an average of 750.0 microns to 481.6 microns. Visual acuity was improved from 1.85 LogMAR (Finger Count) pre-operatively, to 0.34 LogMAR during the post-surgery follow-up  (p-value <0.05). In all 14 patients the EndoArt remained adherent throughout the study period. In 3 patients (25%), one re-bubbling procedure was needed post-operatively. During the follow-up, in 3 patients, the implant was explanted d/t a personal request, and endothelial corneal keratoplasties were performed.

In all patients, we observed alleviation of stromal edoema and improvement in visual acuity. No pathological thinning, toxic reactions, opacification of the cornea, or other side effects, or complications were seen with either patients with EndoArt implantation only, or patients who underwent a combined surgery of EndoArt implantation and cataract extraction. The EndoArt is a novel device that will allow treatment of more patients with endothelial disease as compared with donor tissue (banking) availability. This treatment modality has promising results, but still stays during the development steps. The patient selection process is important and demands finding the appropriate patients.