跳至主要内容
临床试验/NCT04541524
NCT04541524Unknown不适用

Vienna Preserflo Microshunt Cohort Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年6月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
IOP

研究概览

简要总结

The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.

详细描述

During the inclusion period two slightly different surgical approaches have been used. At the beginning of the surgery, the conjunctiva is opened and the Tenon capsule is getting dissected from the sclera. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. The outcomes of these two groups will be compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Glaucoma patients who received a PMS in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited

排除标准

  • Unwilling or unable to give informed consent.
  • Pregnancy or lactation

结局指标

主要结局

IOP

时间窗: one year

IOP in mmHg

Qualified success

时间窗: one year

IOP below 21 and IOP reduction of at least 20% from baseline with or without medication

Full success

时间窗: one year

IOP below 21 and IOP reduction of at least 20% from baseline without medication

Complications

时间窗: one year

Number of complications per eye

次要结局

  • Medication rate(one year)
  • Corneal endothelial cell count(one year)
  • OCT - shunt length(one year)
  • OCT - shunt entry(one year)
  • Re-intervention rate rate(one year)
  • Average medication(one year)
  • OCT - shunt clearance(one year)

研究者

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

Clemens Vass

Univ.Prof.Dr.med.univ.

Medical University of Vienna

研究点 (1)

Loading locations...

相似试验