The concentration of mitomycin C and wound healing reaction and safety in trabeculectomy with mitomycin C

Ministry of Food and Drug Safety0 个研究点目标入组 36 人开始时间: 待定最近更新: 2019年7月17日

适应症

试验速览

暂无简介。

•Patients diagnosed with POAG, PACG, pseudoexfoliation glaucoma, or secondary glaucoma were screened. The inclusion criteria were age older than 20 years, and inadequate IOP control despite maximally tolerated medical therapy. In addition, eyes with IOP less than 21 mmHg while receiving medical therapy but with progressive optic nerve damage or visual field (VF) deterioration were included. Diagnosis of glaucoma was made based on an optic disc examination and the presence of a VF defect. Glaucoma eyes were defined as eyes showing glaucomatous optic disc appearances (i.e., neuroretinal rim thinning, notching, and/or retinal nerve fiber layer (RNFL) defects) and corresponding glaucomatous VF defects.

•Exclusion criteria were patients with previous intraocular surgery except cataract operation and those with a known allergy to MMC. Patients with anterior-segment pathologic features that could affect IOP measurement (penetrating keratoplasty, keratoconus, refractive surgery) and posterior-segment pathologic features that could interfere with optic nerve head or VF assessment (non-glaucomatous optic neuropathy, diabetic retinopathy, vascular occlusion) were also excluded. In addition, patients with thrombocytopenia, coagulopathy, those receiving phenytoin as a yellow fever vaccine or prophylactic agent, and women with fertility who were pregnant or planned to become pregnant during the follow-up period were excluded. In cases where both eyes of a subject were eligible for the study, the eye that had undergone surgery first was chosen for inclusion.

发起方

Ministry of Food and Drug Safety