NCT04110067招募中不适用
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia
Suphi Taneri1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Subjective Distance Refraction
研究概览
简要总结
Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism.
It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient.
This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D.
It is to
- gather long-term results and refractive stability
- detect rare complications or side-effects
- evaluate the efficacy in a large number of patients
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •myopia more than -7.75 D
- •refractive stability more than 1 year
排除标准
- •corneal irregular astigmatism
- •ectatic conditions
结局指标
主要结局
Subjective Distance Refraction
时间窗: 1 year
Subjective Refraction
Distance Visual Acuity
时间窗: 1 year
Visual Acuity sine and cum correctione
次要结局
- Epithelial thickness map in Optical coherence tomography(1 year)
- Tectonic stability as assessed by Pentacam(1 year)
研究者
Suphi Taneri
Director
St. Franziskus Hospital
研究点 (1)
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