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临床试验/NCT01752478
NCT01752478已完成不适用

Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Reduction of levator function

研究概览

简要总结

The purpose of this study to is to determine the incidence of post-operative ptosis in patients undergoing vitreoretinal surgery. An additional purpose is to identify pre-operative and intra-operative factors which correlate to the development of post-operative ptosis in vitreoretinal surgery cases.

详细描述

This study will evaluate patients who will undergo vitreoretinal surgery at UCSF Medical Center and San Francisco General Hospital. After informed consent has been obtained, the measurement of eyelid parameters such as levator function, palpebral fissure height, upper eyelid crease height, MRD1 and MRD2 will be collected at pre-operative and post-operative follow up visits. External eye photographs taken at each visit will be evaluated by a masked reader who will calculate the eyelid parameters. Dermographic data and intraoperative factors such as operative time and type of procedure will be collected. For statistical analysis, Repeated ANOVA, Paired t-test, Wilcoxon signed rank test, Chi-square test and Pearson's correlation analysis will be calculated with SPSS software.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients who have vitreoretinal surgery from January 2013

排除标准

  • Minors, younger than age
  • Patients who have pre-existing ptosis at baseline in the operative eye.
  • Patients who are not able to cooperate with eyelid ptosis measurements

结局指标

主要结局

Reduction of levator function

时间窗: Baseline to 6 months

Difference between levator function at baseline and 6 months after surgery

次要结局

  • Operative time(At operation)
  • Incidence of ptosis(baseline to 6 months)
  • Change of palpebral fissure height, MRD1 and MRD2(Baseline to 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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