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临床试验/NCT04949347
NCT04949347已完成不适用

Glycerin-Preserved, Human-Donor, Corneoscleral Patch Grafts for Glaucoma Drainage Devices

Siriraj Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Numbers of eyes with graft related complication

研究概览

简要总结

This was a retrospective, non-comparative study of 100 eyes of 100 consecutive glaucoma patients who had undergone glaucoma drainage device implantation (Baerveldt shunt) during January 2006 to December 2016. Glycerin-preserved, human-donor, corneoscleral tissue was used as a patch graft to cover the tube portion of the GDD over the sclera. The patch graft related complication was comparable to the previous reports using conventional sclera or pericardium.

详细描述

This retrospective, non-comparative study was conducted at the Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. The medical records of consecutive patients who had undergone glaucoma drainage device implantation employing the fornix-based conjunctival flap technique and using a glycerin-preserved, human-donor, corneoscleral graft. The procedures were carried out by, or under the supervision of, one surgeon (NK) between January 2006 and December 2016 were reviewed. The study protocol was approved by the Siriraj Institutional Review Board, Faculty of Medicine, Siriraj Hospital, Mahidol University.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Consecutive patients who had undergone glaucoma drainage device implantations between January 2006 and December 2016 at Siriraj hospital by or under supervision of one surgeon (NK).
  • The GDD implantation using glycerin-preserved, human-donor, corneoscleral tissue as a patch graft

排除标准

  • 1.Patients who had follow-up period less than 12 months after operation.

结局指标

主要结局

Numbers of eyes with graft related complication

时间窗: Postoperative period from January 3, 2006 to August 31, 2019

Numbers of eyes with the patch-graft related complications included tube exposure, infection, leaking, etc

次要结局

  • numbers of medication(Postoperative period from January 3, 2006 to August 31, 2019)
  • Intraocular pressure(preoperative and postoperative period from January 3, 2006 to August 31, 2019)
  • Visual acuity(Postoperative period from January 3, 2006 to August 31, 2019)
  • Numbers and types of post-operative intervention(Postoperative period from January 3, 2006 to August 31, 2019)

研究者

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

Naris Kitnarong

Associate professor

Siriraj Hospital

研究点 (1)

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