Endoart - The New Synthetic Corneal Endothelium Implant (Our Preliminary Results)

The purpose of this case series is to describe a novel device EndoArt® (EyeYon Medical, Ness Ziona, Israel) that may serve as an alternative to Descemet membrane endothelial keratoplasty (DMEK). The device is used for the treatment of chronic corneal edema due to endothelial dysfunctions such as Fuchs’ endothelial dystrophy, pseudophakic bullous keratopathy (PBK) or failed endothelial grafts.

Tbilisi State Medical University Eye Clinic “Akhali Mzera”, Tbilisi, Georgia

The EndoArt® implant is a 6.5-mm diameter, disc with the thickness 50-μm which serves as an artificial fluid barrier between the recipient’s posterior stroma and the anterior chamber.  In our study 5 eyes of 5 patients with PBK underwent EndoArt® implantation. The procedure was performed in accordance with the guidelines provided by the manufacturer.

Mean Central Corneal Thickness (CCT) was 792.6 μm (673 to 996 μm) preoperatively which decreased to 527.8 μm (490 to 569 μm) 2 weeks postoperatively. Although 4 out of 5 eyes required one re-bubbling procedure due to partial detachment of the implant, the CCT changes were consistent. Patients did not complain of pain during postsurgical period. All patients reported high satisfaction as the Visual Acuity (VA) improved and the reduction in eye pain - Visual Analog Scale (VAS) score decreased from >50mm at baseline to 0-mm postoperatively. No inflammatory reaction was observed in the treated eyes during the post-surgical follow-up examinations. There were no clinically significant, device-related side-effects and/or complications observed.

The EndoArt® is demonstrating clinical parameters supporting its design as a sterile, inert biocompatible polymer and resiliency. Those support simplicity of the surgical procedure, while exhibiting corneal thickness and pain reduction, and improved VA over time. Although no severe adverse events were observed, further studies should be conducted to investigate the safety and efficacy of the novel device.