Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis Regarding Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Oxford score
研究概览
简要总结
Comparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral eyes with spherical correction range from -2 to -6 diopters and cylinder range from 0 to - 3.5 diopters
排除标准
- •sign or symptom of dry eye disease (tear film breakup time (TBUT) >10 seconds
- •Schirmer I test >10 mm /5 minutes)
- •corneal or conjunctival staining
- •Meibomian gland dysfunction
- •Previous ocular and or eyelid medical or surgical treatment
- •pregnancy
- •Chronic systemic disorder
结局指标
主要结局
Oxford score
时间窗: After 6 months of surgery
Oxford score (the score range from 0 to 5), higher value indicate more severe disease
Schirmer I test
时间窗: After 6 months of surgery
Schirmer I test (in mm/5 minutes)
Tear Break-Up Time
时间窗: After 6 months of surgery
Tear Break-Up Time (in seconds)
Dry Eye Work Shop scale
时间窗: After 6 months of surgery
Dry Eye Work Shop scale (value range from 0 to 4), higher value indicate more severe disease
Ocular Surface Disease Index
时间窗: After 6 months of surgery
Ocular Surface Disease Index (the index range from 0 to 100), higher value indicate more severe disease
次要结局
未报告次要终点