NCT06788418招募中不适用
Comparative Study of SMILE, ICL, and Wavelight Plus Alcon Technologies in Myopia Correction
Beijing Visionly Plus Eye Hospital4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Vision at 12 months post-surgery
研究概览
简要总结
Myopia is a prevalent refractive error with significant lifestyle impact. While traditional SMILE (Small Incision Lenticule Extraction) and ICL (Implantable Collamer Lens) surgeries are standard options, the advent of the Wavelight Plus Alcon system presents a promising new technique. This trial aims to evaluate the safety, efficacy, and patient satisfaction across these methods.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-40 years
- •Spherical equivalent of -1.00 to -10.00 D
- •Stable refraction for at least 12 months
- •Informed consent provided
排除标准
- •Other ocular pathologies
- •Previous refractive surgery
- •Pregnancy or nursing
- •Autoimmune or connective tissue disorders
结局指标
主要结局
Vision at 12 months post-surgery
时间窗: From the day of surgery through to the 12-month post-operative follow-up
Uncorrected distance vision (UDVA) at 12 months post-surgery
次要结局
- Change in spherical equivalent at 12 months post-surgery(From the day of surgery through to the 12-month post-operative follow-up)
研究者
研究点 (4)
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