UP TO 5 YEARS RESULTS WITH AN ENDOTHELIAL KERATOPROSTHESIS.

To report up to 5 years results of implantation of the EndoArt (Eye Yon Medical, Israel) in terms of safety, device adherence, corneal thickness, central cornea clarity, adverse effects, and visual acuity.

  Cornea service at the Ophthalmology department of an Academic Institution.

Consecutive interventional case series. The EndoArt is a prosthetic dome shaped acrylic implant of 6.5 mm diameter, intended for replacement of dysfunctional endothelium. The EndoArt functions as a physical barrier preventing fluid uptake into the cornea stroma leading to a new equilibrium & decrease in corneal thickness. The EndoArt was implanted in 10 eyes of 10 patients for indications of corneal edema. In 8 out of 10 eyes the indication was tectonic, because of complex posterior segment pathology.

Follow-up times ranged from 6-60 months. In 9 of 10 eyes the EndoArt remained adherent throughout the follow up period. In 7 out of 10 eyes a temporary corneal suture was used to aid initial adherence, which reduced rebubbling rates. No immediate perioperative or post operative complications occurred, especially not pathological thinning of the cornea was seen. In 1 patient a retinal detachment occurred 44 months after implantation. In 7 out of 10 visual acuity improved, even though this was not expected in the most complex eyes. Central corneal thickness on OCT decreased with a mean of 26.8%. In 1 patient no effect was seen. In 1 patient the EndoArt failed to adhere. This was a post PKP, DSAEK and DMEK eye with severe distortion of the posterior cornea. In 3 of 10 patients more than 1 suture was used, which lead to better and earlier adhesion of the EndoArt.

The EndoArt remained in situ in 9 patients in this cohort. In most patients’ corneal thickness and stromal edema was reduced. In 6 of 10 patients visual acuity improved. No complications related to the implant were seen. Suturing the device led to decreased rebubble rates and improved adherence. Results with our patient cohort are encouraging as to the feasibility and effect of the EndoArt. More follow up in more patients is needed to elucidate the exact indications for the use of an artificial corneal endothelial device.