Outcomes Of Endoart® Implantation In Patients At High Risk For Human Graft Rejection

To report twelve months safety and efficacy outcomes of implantation of an impermeable artificial lamella (EndoArt®) on the posterior surface of the cornea of adult patients suffering from chronic corneal edema who were at high risk for human graft rejection.

The EndoArt® (EyeYon Medical, Ness Ziona, Israel) was implanted in 76 high- risk patients. Fifty-three (53) of the 76 were operated as part of a clinical trial, 16 were compassionate cases and additional 7 patients were implanted with EndoArt® following CE approval.

The EndoArt® (EyeYon Medical, Ness Ziona, Israel) was implanted in 76 high- risk patients. These patients either failed multiple keratoplasties or had a condition placing them at risk for human graft failure. Safety and efficacy data, including central corneal thickness (CCT), best corrected visual acuity (BCVA) and pain score (measured by visual analogue scale, VAS) are presented for the first 12 months post implantation.

Central corneal thickness (CCT) decreased significantly from 762 ± 159 μm at baseline (n=76) to 562 ± 128 μm at 6 months and 562 ± 141 μm at 12-month follow-up (p ≪ 0.05).Patient-reported pain scores (VAS/NRS) were markedly reduced from 18 ± 19 preoperatively (n=58) to 5 ± 11 at 12 months post-implantation (p < 0.05).Despite limited baseline visual potential and significant co-morbidities, best-corrected visual acuity (BCVA) improved significantly from 1.72 ± 0.52 logMAR preoperatively to 1.30 ± 0.64 logMAR at 12 months. In eyes with visual potential, BCVA reached up to 6/9.

No long-term infections or inflammatory complications related to EndoArt® implantation were reported.

The implant demonstrated safety and efficacy in treating chronic corneal edema in high-risk patients prone to graft rejection, leading to reduced edema and pain while improving vision in most cases. Comparison with lower-risk patients showed similar trends of CCT, pain and vision improvement, though re-bubbling rate was lower in the lower-risk group. As EndoArt® is not subject to rejection, it may offer a durable long-term solution for high-risk patients.