NCT06992011招募中不适用
A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 300 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
- 300
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
To evaluate and compare the clinical efficacy, biomechanical stability, and optical quality of SMILE and SMILE Xtra procedures in patients with myopia through a randomized controlled trial
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 (Participant)
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 18-50 years
- •MRSE (Manifest Refraction Spherical Equivalent) -6.00D to -10.00D with refractive changes within ±0.50D in past 2 years
- •CDVA (Corrected Distance Visual Acuity) ≥ 20/25
- •Myopia progression ≤ 0.50D/year for ≥2 years
- •RST (Residual Stromal Thickness) ≥ 250μm after lenticule removal
- •Contact lens discontinuation as per protocol
排除标准
- •Other eye diseases (keratoconus, glaucoma, etc.)
- •Corneal scarring, cataracts affecting observation
- •Systemic diseases affecting surgery compliance
- •Prior ocular surgeries
- •Pregnancy, breastfeeding, or menstruation
- •Drug allergies to surgical medication
结局指标
主要结局
visual acuity
时间窗: 1 week, 1 month,3 months， 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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