Early Vitrectomy for Macular Tractional Maculopathy. Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 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 identify the effect of current vitreous surgery for symptomatic macular tractional maculopathy.
Characteristics of this study is as below
- Multicenter, prospective clinical trial. (early surgical intervention vs.surgical intervention when full-thickness macular hole formation or deterioration of visual acuity occurs)
- Non-randomized study (decision was made by patients after full explanation)
- After 1 year follow up, functional change(visual acuity)and anatomical change would be evaluated
详细描述
Degenerative myopia is relatively common disorder, especially in Korean, Japanese and Chinese.
Choroidal neovascularization is well-noted cause of VA deterioration, but nowadays, with improvement of diagnostic tools, such as OCT, VA deterioration from myopic tractional maculopathy is being concerned as well.
But till now, the necessity of early vitrectomy on MTM is controversial. By now some clinicians prefer conservative treatment, which means pars plana vitrectomy would be postponed till structural change such as macular hole formation is noticed. And the others prefer early vitrectomy, which means pars plana vitrectomy should be performed when the symptom begins.
In this study, investigators try to verify the validity of early vitrectomy comparing conservative treatment.
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
- 20 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 20 years
- •Symptom duration < 6 Months
- •Visual acuity on trial: more than 20/320 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
- •Any evidence of atrophic change, scar or exudation on macula active intraocular inflammation
- •History of intraocular surgery other than uncomplicated cataract extraction 3 months 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)