As-Oct Analysis Of Artificial Endothelial Layer (Endoart) Implantation: One-Year Experience

Endothelial keratoplasty (EK) is the treatment of choice for patients with all types of corneal endothelial dysfunction. Still, concerns regarding long-term graft survival are relevant, particularly for some patients. A potential solution to this issue may come from the introduction of a novel device named EndoArt, that acts as an artificial fluid barrier replacing the function of the diseased corneal endothelium. Aim of the study is to illustrate the behaviour of the artificial endothelium using AS-OCT analysis, during the first year of our experience.  

Ophthalmology Unit, Sant’Orsola – Malpighi Hospital, Bologna, Italy

We analysed AS-OCT images of patients who underwent EndoArt implantation at week 1, month 1, 3, 6 and 12, whenever feasible. We measured corneal central thickness (CCT) before the surgery and after it, excluding DSAEK and the implant. We reviewed images to evaluate the presence of implant detachment, its localization and extension. In addition, we evaluated the presence and the extension of annular fibrosis, visible as an hyper-reflective band, developing along the margins of the Endoart.  

Surgery on 9 patients resulted in 4 needing implant removal due to posterior stromal adherence issues. Patients retaining implants saw significant reduction in CCT (804.6 ± 134.7 μm) at months 3 (538.6 ± 51.6 μm), 6 (588 ± 60.4 μm), and 12 (595.8 ± 104.7). Complete device detachment (38%) was predominant, followed by infero-temporal (29%). 3 of 5 patients with longer follow-up developed annular fibrosis around 3 months post-surgery, which reformed swiftly after detachments. Two patients had stable superior-temporal detachment extending approximately 20° for 6 months post-surgery, showing unchanged fibrosis. Interestingly, patients with more detachments and corneal opacity did not develop evident fibrosis observed in others.

Artificial endothelium effectively reduces corneal edema and consequent corneal thickness, with efficacy persisting up to one year post-implantation. Device detachments more frequently originate in the inferior sectors, holding clinical significance and being more prone to extension. Conversely, superior detachments, with an extension not exceeding 20-30° of circumference, tend to remain localized and cause minimal edema and loss of cornea transparency and may not require rebubbling. Overall, annular fibrosis does not appear to significantly prevent detachment occurrence; however, it seems to correlate with implant functionality and thus with the maintenance of corneal transparency.