Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- visual outcomes
研究概览
简要总结
this is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia.
详细描述
This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients were eligible for the study if they were older than 18 years and younger than 40 years.
- •Stable myopia up to -6.0D and astigmatism up to -3.0D determined by manifest refraction for at least 6 months.
- •best corrected distance visual acuity of at least 20/20, and stable keratometry after cessa¬tion of soft contact lens wear for at least 2 weeks.
排除标准
- •any anterior seg¬ment pathology.
- •any form of retinal degeneration. unstable myopia.
- •severe dry eye.
- •corneal thickness that would have resulted in less than 300 µm residual stromal thickness.
- •Patients who had keratoconus or were keratoconus suspects.
- •previous ocular sur¬gery.
- •a history of herpes zoster ophthalmicus or herpes simplex keratitis.
- •a history of a steroid-responsive rise in in¬traocular pressure (IOP) or a preoperative IOP of more than 21 mmHg.
- •diabetes mellitus, autoimmune dis¬ease, connective tissue disease, and chronic use of systemic corticosteroid or immunosuppressive therapy were also excluded from the study.
结局指标
主要结局
visual outcomes
时间窗: 6 months
uncorrected and best corrected distant visual acuity in LogMAR
refractive outcomes
时间窗: 6 months
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
次要结局
未报告次要终点
研究者
magda torky
priniciple investigator
Dar Al Shifa Hospital