NCT06973278招募中不适用
A Prospective Study on Clinical Effectiveness After SMILE Versus SMILE Xtra in Myopia
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月1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
- 200
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
To evaluate the clinical efficacy and refractive stability of SMILE Xtra compared to SMILE in patients with myopia
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years.
- •High myopia with a manifest refraction spherical equivalent (MRSE) - 6.00D～-10.00D and refractive changes within ± 0.50D in the past two years;
- •Best corrected distance visual acuity (CDVA) ≥ 20/
- •Preoperative refractive status is stable (myopia progression not exceeding 0.50D per year for at least 2 years).
- •Predicted residual stromal thickness (RST) ≥ 250μm after lenticule removal. 6.Soft contact lenses discontinued for at least 1 week, rigid contact lenses for at least 3 weeks, and orthokeratology lenses for at least 3 months.
排除标准
- •The presence of other eye diseases: keratoconus or suspected keratoconus, active keratoconjunctivitis, severe dry eye, glaucoma, retinal diseases such as retinal tears or macular degeneration, etc.,
- •The presence of significant corneal scarring or cataracts affects observation.
- •Systemic diseases such as active systemic inflammation, connective tissue diseases, other conditions that prevent
结局指标
主要结局
visual acuity
时间窗: 1 week, 1 month, 6 months, 12 months，24 months and 36 months
次要结局
未报告次要终点
研究者
研究点 (1)
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