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临床试验/NCT07350200
NCT07350200已完成不适用

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

Military Institute od Medicine National Research Institute0 个研究点目标入组 150 人开始时间: 2014年12月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150

研究概览

简要总结

XEN Glaucoma Implant for the Management of Operated Uncontrolled Glaucoma: Results and Complications During a Long-Term Follow-Up

详细描述

Purpose of the study is to analyze the surgical and refractive outcomes of XEN glaucoma implant, a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Intraocular pressure change, best corrected visual acuity, change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • presence of OUG, defined as prior treatment with surgical or cyclodestructive procedures
  • failure to achieve target IOP with maximally tolerated topical IOP-lowering treatment or intolerance to drugs
  • both primary and secondary open- and closed-angle glaucoma cases
  • presence of healthy mobile conjunctiva in at least one quadrant and bestcorrected visual acuity

排除标准

  • presence of clinically significant inflammation or infection within 30 days before surgery, history of corneal refractive surgery, corneal deposits or haze preventing intraoperative viewing of the anterior chamber, presence of an anterior chamber lens, advanced age-related macular degeneration (AMD), known or suspected allergy or sensitivity to porcine products or glutaraldehyde, pregnant or nursing women, and lack of consent to participate in the study

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Sponsor

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