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临床试验/NCT04552314
NCT04552314已完成不适用

Predictive Value of Postoperative Filtering Bleb Vascularity in Mitomycin-C Augmented Trabeculectomy

Medical University of Lublin0 个研究点目标入组 51 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
主要终点
Rates of surgical success

研究概览

简要总结

  1. Study objective: To evaluate the relationship between filtering bleb vascularity and the surgical outcomes after trabeculectomy
  2. Study design: A prospective study of 51 eyes of 44 patients after primary MMC-augmented trabeculectomy. The follow-up was 12 months.

详细描述

Total vessel area of a filtering bleb was measured with ImageJ software on colour photographs of a filtering bleb on day 1, 14, 1, 3 and 6 months and 1 year after trabeculectomy. Blebs were classified clinically as successful (IOP below 18 mmHg and a >30% reduction in IOP without antiglaucoma medications or additional surgical interventions) or failed. Linear regression analysis was performed to determine the correlation of the bleb vascularity with IOP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary open angle glaucoma (POAG) with medically uncontrolled intraocular pressure (IOP)
  • pseudoexfoliation glaucoma (PEXG) with medically uncontrolled intraocular pressure (IOP)

排除标准

  • primary angle closure glaucoma (PACG)
  • secondary glaucoma except PEXG
  • previous eye surgery
  • subjects with decreased vision due to other reasons than glaucoma (e.g., exudative age-related macular degeneration (AMD), proliferative diabetic retinopathy, inflammatory eye diseases)

结局指标

主要结局

Rates of surgical success

时间窗: 1 year

The successful bleb group consisted of eyes with IOP below 18 mmHg and a \>30% reduction in IOP at 1 year after surgery without antiglaucoma medications or additional surgical interventions. Failed blebs were defined when IOP was over 18 mmHg, below 18 mmHg with antiglaucoma medications or if any additional surgical intervention was necessary

次要结局

  • Correlation of Bleb vascularity with IOP(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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