Objective:To evaluate efficacy and safety of the Mihe keratoprosthesis(MIOK)with autologous auricular carti-lage reinforcement for bilateral end-stage corneal blindness.Methods:This was a prospective,single-center,sin...Objective:To evaluate efficacy and safety of the Mihe keratoprosthesis(MIOK)with autologous auricular carti-lage 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 implanta-tion.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.展开更多
基金supported by the Capital Clinical Characteristic Key Projects(Grant No.Z161100000516012)The capital health research and development of special(Grant No.2024-1-5043).
文摘Objective:To evaluate efficacy and safety of the Mihe keratoprosthesis(MIOK)with autologous auricular carti-lage 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 implanta-tion.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.
