NCT00401713已完成不适用
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004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
- 40
- 试验地点
- 2
- 主要终点
- Visual Acuity: distance and near
研究概览
简要总结
The purpose of this study is to evaluate two surgical interventions in patients with AMD.
详细描述
The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AMD and submacular cnv
- •non responders to laser treatment or pdt
- •treatment: rpe transplantation or rpe + choroid translocation
- •age over 50 years
排除标准
- •other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
- •optic atrophy
- •unstable glaucoma
结局指标
主要结局
Visual Acuity: distance and near
时间窗: preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months
FLA
时间窗: (preoperatively, 3 months, +/- 12 months after surgery)
次要结局
- OCT((preoperatively, 3 months, 12 months after surgery))
- UHR OCT((after surgery, including silicone oil removal))
- autofluorescence((preoperatively, 3 months, +/- 12 months after surgery))
- perimetry((if feasible))
研究者
研究点 (2)
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