NCT03328715已完成不适用
iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study
Vienna Institute for Research in Ocular Surgery2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- macular thickness
研究概览
简要总结
Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT
详细描述
48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
- •Diabetic macula edema - for the study group
- •Age 21 and older
- •written informed consent prior to surgery
排除标准
- •Any relevant corneal disease
- •In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
结局指标
主要结局
macular thickness
时间窗: 2 hours
macular thickness is measured with the central subfield thickness function
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Prim, Prof.,
Vienna Institute for Research in Ocular Surgery
研究点 (2)
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