Endothelial Keratoprosthesis Longitudinal Follow Up Cohort In The Netherlands

The EndoArt is the worlds first endothelial keratoprosthesis that is implanted for endothelial failure and corneal edema. In this report we show the follow up data of implantations performed since 2019 in the Netherlands. The device is an acyrlic hydrophilic dome-shaped implant of 6.5 mm in diameter which is attached to posterior corneal surface to induce a barrier allowing for corneal deturgecence and clearing. This device is an additional treatment option to traditional donor tissue endothelial keratoplasty.

Academic cornea units in 2 university hospitals.

In this longitudinal intervendional case series results of implantation with the EndoArt (Eye Yon Medical) are shown. All patients implanted with the EndoArt are included in the cohort. Outcome measures reported are: adherence rates, corneal thickness and clearance data, rebubble rates, suture use, visual acuity, intraocular pressure, painscores, and complications. The EndoArt was implanted in 28 eyes of 27 patients. Mostly for eyes with complex pathology in which the risk of use of donor tissue and consecutive rejection and failure was high. In 9 eyes the indication for implantation was tectonic. Background pathology includes, posterior segment pathology, glaucoma and glaucoma implant surgery, recurrent graft failure, and ocular trauma.

In 26 of 28 eyes the endothelial keratoprosthesis  remained adherent. The follow up period ranged from 3-72 months. After 1 year the mean reduction of corneal thickness was 24%, with 23% after 3 years. The mean rebubble rate was 1.29 (range 0-6), average sutures used was 2.71 (range 0-7), visual acuity increased from a mean LogMar of 2.13 to 1.5, all intraocular pressure measurements were under 20mmHg, mean VAS painscore reduced from 6.69 to 1.15. No instances of pathological corneal thinning were seen, no intracorneal deposits were observed, in 2 instances the EndoArt failed to adhere, in 2 eyes CME was diagnosed and succesfully treated, in 4 eyes epithelial fibrosis developed.  

The EndoArt, a novel endothelial artificial keratoprosthesis, shows promising results in complex cases of corneal decompensation. The device remains adherent in the long-term, with proven deturgencence of the cornea stroma. Visual acuity does improves in patients with visual potential. Complication rate is low. No device related complications such as pathological thinning were seen. The device is currently used to treat eyes with high risk for donor rejection and failure. Continued investigation and follow up is still needed.