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临床试验/NCT00863018
NCT00863018已完成不适用

Change in Corneal Endothelium After Glaucoma Surgery; Trabeculectomy and Glaucoma Implant Surgery

Chungnam National University1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2003年8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
61
试验地点
1
主要终点
Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area

研究概览

简要总结

The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.

详细描述

To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Patients who need glaucoma surgery for intraocular pressure control

排除标准

  • congenital glaucoma
  • Pre-existing corneal abnormality
  • lost from follow up without any ocular problem within 6 months from surgery

结局指标

主要结局

Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area

时间窗: 1 and 2 years longitudinal follow up

次要结局

  • Clinical factors associated with the damage of corneal endothelium after glaucoma surgery(1 and 2 years longitudinal follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang-sik Kim

professor

Chungnam National University

研究点 (1)

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