Clinical Results Of 4.5 Years With A Prosthetic Corneal Endothelial Prosthesis.

To report the 4.5 years results of implantation of the EndoArt (Eye Yon Medical, Israel) in terms of safety, device adherence, 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. 7 eyes of 7 patients, participants in the first in human safety and feasability study are included. Inclusion was for endothelial failure only, without other corneal or glaucoma surgery and a bad visual prognosis secondary to posterior segment pathology (phase 1 study). Another 2 eyes of 2 patient the EndoArt was implanted for repeated graft failure. Here previous corneal or glaucoma surgery was not an eclusion criterium. 

The EndoArt device was implanted in 9 eyes of 9 patients. Follow up times ranged form 6-52 months. In all the patients the EndoArt remained adherent througut the follow up period. In 6 out of 9 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 thinnnig of the cornea was seen. In 1 patient a retinal detachment occured 44 months after implantation. In 5 out of 9 visual acuity improved, even though this was not expected. Central corneal thickness on OCT decreased with a mean of 26.8%. In 1 patient no effect was seen. In 1 patient a re-PKP was done after 1 year. 

The EndoArt remained in situ in 8 patients in this cohort. In most patients corneal thickness and stromal edema was reduced. In 5 of 9 patients imporved visual acuity was found. No complications related to th eimplant were seen. Adherence of the device improved with the use of a temporary corneal suture.The use of a suture reduced the rebubbling rates significanlty. More study is needed to explore the safety and efficacy of this device. Results up to now are promising in terms of corneal clarity and in some cases also in improved visual acuity even though this ws not expected.