Use of the VisuMax Femtosecond Laser for the Correction of Myopia With Small Incision Lenticular Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
Evaluation of the safety and efficacy of the Carl Zeiss Meditec VisuMax femtosecond laser for lamellar resection (ReLEx smile) in the reduction of myopia.
详细描述
Quality control study of patients treated with ReLEx smile for myopia at the Department of Ophthalmology, Aarhus University Hospital.
The patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for keratorefractive correction of myopia
- •Patient consent to undergo keratorefractive correction of myopia
排除标准
- •Pregnant or lactating women
结局指标
主要结局
Effectiveness
时间窗: Refraction one year after surgery
Achieved change in refraction (spherical equivalent, SE) in diopters will be compared with attempted change in refraction (SE) in diopters. Data will be reported as fraction of eyes within an error (achieved - attempted) of +/- 0.5 diopters (SE) and within an error of +/- 1 diopters (SE).
Safety
时间窗: One year after surgery
Data will be reported as: * Percentage of eyes with best spectacle corrected visual acuity (BSCVA) worse than 20/40 for eyes with BSCVA of 20/20 or better before survey * Percentage of eyes that lose 2 Snellen lines or more of BSCVA
次要结局
未报告次要终点
研究者
Jesper Hjortdal
Professor, consultant, MD, PhD
University of Aarhus