A Novel Endothelial Keratoprosthesis: 2 Years Follow Up With The Endoart Device.

To report the 2-year outcomes of the Dutch cohort of the first in human safety study of implantation of the endothelial keratoprosthesis, the EndoArt.

Department of Ophthalmology, Academic setting, Amsterdam UMC, University of Amsterdam, the Netherlands.

In a prospective non-randomized safety study patients with endothelial failure, and poor visual prognosis caused by posterior segment pathology, were included. Previous glaucoma or corneal surgery was an exclusion criterium. Primary outcome measures were device adherence, safety,  corneal thickness on OCT, adverse effects. Secondary outcome measures were visual acuity, and visual acuity. The endoart functions as partial barrier device prevent seepage of fluids form the AC into the corneal stroma.

In 7 patients the endoart device was implanted. In all 7 the endoart remained adherent during the study period of 1 year. Follow up time ranges from 10 months to 32 months. In 3 out of 7 patients the visual acuity improved (even though this was not expected). In 4 out of 7 theh EndoArt was sutured to aid initial adherence. No pathological thinning of the cornea seen, neither were any other adverse effects observed. Central cornea thickness on OCT was reduced by a mean of 24%. In 1 patient no effect was seen.

The EndoArt remained adherent in all patients of this cohort. In most patients intended corneal thinning and alleviation of stromal edema was observed. No pathological thinning or opacification of the cornea were seen. No ocular or other side effect or complications were seen. Adherence improved by use of a suture. The EndoArt is a novel device that will allow treatment of more patients with endothelial disease whereas now this is impossible due to donor tissue (banking) availability or cost. This is a treatment modality in development in the quest for alleviation of corneal blindness in the world.