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临床试验/NCT02423382
NCT02423382已完成不适用

Measurement of the Retinal Oxygen Saturaiton After Long-term Silicon Oil Tamponade With Oxymap

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2014年2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
49
试验地点
1
主要终点
The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months

研究概览

简要总结

The purpose of this study is to evaluate the effects of long-term tamponade with silicone oil on retinal saturation with Oxymap.

详细描述

Silicone oil is the first choice treatment for long-term vitreous replacement in complicated cases of retinal detachment. However, it will cause various problems for permanent tamponade, such as keratopathy, glaucoma, cataracts, and silicone oil emulsification3. In addition, silicone oil has the potential to cause retinal toxicity. Moreover, the gravity and mechanical pressure of the silicone oil on the retina may influence retinal blood flow and, and the presence of silicone oil in the vitreous cavity may block the oxygen exchange between the retinal surface and the vitreous humor, resulting in the metabolic disturbance of the retina. In this study, the investigators utilized a noninvasive measurement (Oxymap, Reykjavik, Iceland) to evaluate the effect of silicone oil tamponade on oxygen saturation and diameter in retinal vessels in complicated retinal detachment cases.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • initial silicone oil tamponade duration of more than 3 months
  • transparent reflecting media
  • intraocular pressure (IOP) between 11 and 21mmHg
  • complete retinal re-attachment
  • healthy contralateral eye.

排除标准

  • severe refractive media opacity (serious keratoleukoma and cataracts)
  • silicone oil emulsification
  • ocular hypertension
  • retinal detachment
  • retinal scar within the main vascular arch
  • any ocular disease and any history of surgery in the contralateral eye
  • any type of systemic disease
  • pregnancy

结局指标

主要结局

The changes from baseline in the retinal oxygen saturation by Oxymap at 2 months

时间窗: 1 day before silicone oil removal and 2 months after silicone oil removal.

次要结局

  • The changes from baseline in the retinal vessel width by Oxymap at 2 months(1 day before silicone oil removal and 2 months after silicone oil removal.)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bingsheng Lou

DR.

Sun Yat-sen University

研究点 (1)

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