Novel corneal implant in trials
Endothelial implant a possible paradigm shift for corneal transplants
Ruth Lapid-Gortzak MD, PhD
The first in-human trials of a novel artificial implant designed to replace dysfunctional corneal endothelium have shown the device to be safe and well-tolerated, according to a study presented at the 25th ESCRS Winter Meeting online.“The initial results of the EndoArt (EyeYon Medical) are very promising indeed,” said Ruth Lapid-Gortzak MD, PhD, Amsterdam University Medical Centre in the Netherlands.
“There were no device-related adverse events over the 12 months’ follow-up and technically the implantation of the EndoArt is simpler and easier than surgery with donor tissue. In the first four patients, the implant was safely attached throughout the study period and in most patients the corneal thickness decreases without pathological thinning,” she said. Visual acuity also improved in two patients even though that was not a primary goal of the study.
The gold standard for treating corneal endothelial failure is human donor tissue, but there are an estimated 13 million patients currently waiting for corneal tissue globally. A safe and effective artificial endothelium implant would address a fundamental medical need, said Dr Lapid-Gortzak.
With a thickness of 30-50 microns, a diameter of 5-8mm and a curvature of 8mm, the EndoArt is an optically clear dome-shaped flexible disc that is biocompatible and biostable. It works by partially sealing the posterior cornea, decreasing the flow of liquid and establishing a new equilibrium to maintain metabolism.
This initial study had two principal goals, explained Dr Lapid-Gortzak: to demonstrate the adherence of the EndoArt to the cornea and establish a thinner cornea over the follow-up period. The inclusion criteria were eyes with endothelial cell failure with a guarded visual prognosis for non-corneal reasons and with good vision in the other eye.
Of the four patients implanted with EndoArt, all were complex eyes (complicated cataract, distorted pupil, severe atopia, glaucoma, nanophthalmos) with very thick corneas. The vision improved in two patients postoperatively and central corneal thickness decreased in three out of four patients.
“In the one patient where it did not decrease, we think it was due to using an implant that was too small in diameter,” noted Dr Lapid-Gortzak.
The next steps for the device are to confirm its safety according to protocol, improve the implantation technique, reduce re-bubbling and build a nomogram for the sizing of the implant.
“Theoretically, the EndoArt has clear benefits as no tissue or tissue bank is needed, and there are no rejection issues or transmission of infections to worry about. The technique will be cost-effective, scalable and may also provide a temporising measure in case one would like to perform a DMEK at a later stage – for example during the recent COVID epidemic when there was no tissue available,” she concluded.