Efficacy and safety of Mihe keratoprosthesis in Chinese population: a retrospective single-center study

Aim: The aim of this study is to quantify anatomical and functional outcomes of the Mihe keratoprosthesis (KPro) in a Chinese population over a period of 1–3 years and analyze the possible causes of postoperative complications. Materials and methods: Patients who completed both stage 1 and stage 2 Mihe KPro surgery more than or equal to 1 year were included. The interval between stage 1 and stage 2 of the procedure, specifications of the KPro, prognosis, postoperative complications, and any subsequent surgeries were documented. Indications, intraoperative characteristics, postoperative visual acuity, and complications were analyzed. Results: Twenty-eight eyes of 28 patients who underwent Mihe KPro surgery were reviewed with a mean follow-up of 14.4 ± 5.3 months. Chemical burn was shown to be the most common indication for KPro surgery with 13 cases (46.4%). The final postoperative best-corrected visual acuity (BCVA) improved in 22 eyes (78.6%). Postoperative BCVA improved to 0.5 logMAR or better in nine eyes (32.1%) and 1.3 logMAR or better in 14 eyes (50.0%) at 12 months. The retention rate of Mihe KPro was 100% (28 eyes). Complications including anterior proliferative membrane (25.0%), exposure of the KPro stent (7.1%), glaucoma (7.1%), exposure of autologous auricular cartilage (7.1%), retroprosthetic membrane (3.6%), proliferative growth on the surface of the autologous auricular cartilage (3.6%), central retinal artery occlusion (3.6%), and endophthalmitis and retinal detachment (3.6%). Conclusions: Mihe KPro’s wholly domestic design and production mark is a pivotal milestone for Chinese ophthalmology. It offers a new therapeutic option for end-stage corneal blindness, but its long-term efficacy and safety still require validation through larger sample sizes and longer follow-up durations.