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临床试验/NCT02385370
NCT02385370Unknown3 期

Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 126 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
126
主要终点
IOP (intraocular pressure)

研究概览

简要总结

Patients with advanced glaucoma that are candidates for trabeculectomy will be included.

Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Advanced uncontrolled glaucoma patients.

排除标准

  • History of any kind of intraocular surgery.
  • Monocular patients.
  • Unwillingness to participate in the study

研究组 & 干预措施

using standard method of applying MMC

Active Comparator

applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes

干预措施: MMC (Drug)

intratendon injection of MMC

Active Comparator

intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure

干预措施: MMC (Drug)

结局指标

主要结局

IOP (intraocular pressure)

时间窗: until 6 months

Goldmann applanation tonometry

次要结局

  • Bleb morphology(until 6 months)

研究者

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

Zahra Rabbani Khah

Shahid Beheshti Medical University

Shahid Beheshti University of Medical Sciences

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