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 71 high- risk patients. Forty-eight (48) of the 71 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 71 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.

CCT decreased from 764±165μm (n=71) to 560±138μm and 586±155μm at 6 and 12-month follow-up, respectively (p-value<<0.05). Pain (VAS) was markedly reduced from 18±19 pre-op (n=53) to 5±11  at 12 months post implantation (p-value<0.05). Despite low visual potential and co-morbidities, BCVA significantly improved from 1.73±0.53LogMAR to 1.42±0.66LogMAR at 12-month follow-up. There were no long-term reported infections or inflammation related to EndoArt® implantation. A comparison of this high-risk cohort to patients that are not at higher risk for rejection (n=70) resulted in similar trends of CCT improvement and pain relief. BCVA and re-bubbling rate were better in the normal-risk cohort.

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. A comparison with lower-risk patients showed similar trends, though visual acuity outcomes differed, likely due to reduced visual potential. As EndoArt® is not subject to rejection, it may offer a durable long-term solution for high-risk patients.