Mihe (MIOK) KPro with auricular cartilage reinforcement in end-stage corneal blindness: An open-label, nonrandomized trial

Objective: To evaluate efficacy and safety of the Mihe keratoprosthesis (MIOK) with autologous auricular cartilage reinforcement for bilateral end-stage corneal blindness. Methods: This was a prospective, single-center, single-arm, non-randomized clinical trial. Patients with bilateral end-stage corneal blindness for which conventional corneal surgeries or standard Boston type I implantation were contraindicated, were enrolled. All participants underwent Mihe Kpro implantation through a two-stage surgical procedure. Autologous auricular cartilage was utilized to reinforce the tissue on the cornea's surface during each stage. Main outcome measures were keratoprosthesis retention rate, best corrected visual acuity (BCVA) and complications. Results: Thirty-six patients were enrolled, and 35 of these patients completed the Mihe (MIOK) Kpro implantation. The most common indication for Mihe Kpro implantation was alkali burns (15 eyes, 42.9%), followed by end-stage dry eyes (11 eyes, 31.4%), melting metal burns (5 eyes, 14.3%), explosion injury (2 eyes, 5.71%), sulfuric acid burn (1 eyes, 2.86%), and multiple failed penetrating keratoplasty (1 eye, 2.86%). Thirty-four patients retained their initial keratoprosthesis until the final visit, with an average follow-up period of 68.84 ± 35.28 months (Median 85.55 months). Postoperative BCVA improved to 20/200 or better in 92% (23/25) of eyes at the final follow-up. Postoperative complications included fibrovascular tissue overgrowth on the optical surface (5 eyes, 14.3%), macular edema (5 eyes, 14.3%), residual corticle lens (4 eyes, 11.4%), newly acquired glaucoma (3 eyes, 8.57%), infectious endophthalmitis (3 eyes, 8.57%), transient intraocular pressure (IOP) elevation (2 eyes, 5.71%), retroprosthetic membrane (1 eye, 2.86%), and sterile vitritis (1 eye, 2.86%). Conclusions: Mihe KPro reinforced with autologous auricular cartilage provides an effective and safe approach for visual rehabilitation in patients with bilateral end-stage corneal blindness.