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临床试验/NCT01198483
NCT01198483Unknown不适用

Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Refractive outcome

研究概览

简要总结

The purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

详细描述

Purpose:

To compare refractive outcomes after combined cataract and vitreoretinal surgery.

Methods:

Patients with a diagnosis of vitreoretinal disorder and a coexisting significant cataract were randomly assigned to be treated with a microincision cataract surgery and a 23-gauge vitrectomy (treatment group 1) or with a smallincision cataract surgery and a 23-gauge vitrectomy (treatment group 2).

Main outcome measures:

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • diagnosis vitreoretinal disorder with coexisting cataract
  • combined surgery
  • age over 60 years
  • IOL master for preoperative intraocularlens (IOL) calculation

排除标准

  • ultrasound for IOL calculation due to hazy media (dense cataract,vitreous hemorrhage)
  • macular edema, proliferative diabetic retinopathy
  • myopia or hyperopia more than 5 diopters, astigmatism more than 2 diopters
  • previous refractive surgery, retinal detachment surgery, glaucoma surgery and vitrectomy

结局指标

主要结局

Refractive outcome

时间窗: 12 weeks after surgery

Refractive outcome includes autorefraction using Humphrey Automatic Refractor/Keratometer(Carl Zeiss AG, Oberkochen, Germany) and subjective manifest refraction.

次要结局

  • intraocular pressure (IOP)(12 weeks after surgery)
  • functional outcome(12 weeks after surgery)
  • measurements of anterior chamber depth (ACD)(12 weeks after surgery)

研究者

发起方
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christiane I. Falkner-Radler

MD

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

研究点 (2)

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