Mihe (MIOK) KPro with auricular cartilage reinforcement in end-stage corneal blindness: An open-label, nonrandomized trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 35 participants or records.
Read the paper
Related studies
- A Survey on Knowledge Graphs: Representation, Acquisition, and Applications
- Toxicity of nanomaterials
- The Human Gene Mutation Database: towards a comprehensive repository of inherited mutation data for medical research, genetic diagnosis and next-generation sequencing studies
- Halogen bonding (X‐bonding): A biological perspective
- Biofilm formation at the air–liquid interface by the Pseudomonas fluorescens SBW25 wrinkly spreader requires an acetylated form of cellulose
- Opioid Activation of Toll-Like Receptor 4 Contributes to Drug Reinforcement
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.