NCT01121965Unknown不适用
Early Vitrectomy for Impending Macular Hole. Multicenter Clinical Trial
Seoul Retina Investigator Group18 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年11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
- 60
- 试验地点
- 18
- 主要终点
- Best Corrected Visual acuity
研究概览
简要总结
This study is designed to verify hypothesis that early vitrectomy may prevent impending macular hole from progression to full-thickness macular hole.
详细描述
In a study conducted 15 years ago, the 'Vitrectomy for Prevention of Macular hole Study Group' was not able to prove the benefits and advantages of vitrectomy for impending macular hole; however, during the interim period, notable improvements have been achieved with regard to diagnosis and efficacy of treatment.
Therefore, we designed this study to identify the effect of current vitreous surgery for symptomatic impending macular hole.
Characteristics of this study is as below
- Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole occurs)
- Non-randomized study (decision was made by patients after full explanation)
- After 1 year follow up, functional change(visual acuity)and anatomical change(development of full-thickness macular hole) would be evaluated
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female with impending macular hole(identified with OCT)
- •Age: over 45 years
- •Symptom duration < 6 Months
- •Visual acuity on trial: less than 73 letters in ETDRS chart Visual acuity of worsened eye: over 24 letters in ETDRS chart
排除标准
- •Any vision disturbing disease other than impending macular hole
- •Diabetic maculopathy or other retinal vascular disease
- •Prior history of major trauma: If symptom begins after trauma
- •Myopia over -6.5Dioper or eyes with axial length > 28mm
- •Evidence of scar, degeneration or exudation of macula
- •active intraocular inflammation
- •History of intraocular surgery other than uncomplicated cataract extraction 3months before
- •Uncontrolled IOP > 25mmHg
结局指标
主要结局
Best Corrected Visual acuity
时间窗: 48 weeks
次要结局
- Rate of occurrence of full-thickness macular hole(48 weeks)
研究者
研究点 (18)
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