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临床试验/NCT03551834
NCT03551834Unknown1 期

Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月20日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
80
试验地点
1
主要终点
Intraocular pressure(IOP)

研究概览

简要总结

Glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. In order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. Despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. In this study we used a novel technique named short tunnel small flap (STSF) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft.

This randomized clinical trial, was performed at the Glaucoma Clinic of Labbafinejad Medical Center, Tehran, IRAN from September 2015 to January 2017 . The study was approved by the ethics committee at the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and followed the tenets of the Declaration of Helsinki. After explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent AGV implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. Primary outcome measure is Intraocular pressure(IOP) and Tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (IOP) > 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. Outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.

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
是

入选标准

  • •Iranian patients with Caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma.

排除标准

  • •Primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.

研究组 & 干预措施

Using short tunnel small flap technique

Active Comparator

干预措施: New surgical method (short tunnel small flap technique) (Other)

doing scleral patch graft glaucoma implantation

Active Comparator

干预措施: Conventional scleral patch graft glaucoma implantation (Other)

结局指标

主要结局

Intraocular pressure(IOP)

时间窗: 12 months post operatively

Goldmann applanation tonometry

Tube exposure

时间窗: 12 months post operatively

slit lamp examination

次要结局

  • success rate(12 months)

研究者

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

Zahra Rabbani Khah

Clinical Professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

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