Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems Cut
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Measured thickness flap using Confocal microscopy study
研究概览
简要总结
Determine the flap thickness created by femtosecond laser or a mechanical microkeratome using in vivo confocal microscopy and compare measured versus intended flap thickness.
详细描述
Eighty-six eyes had undergone LASIK were examined, al within 2 weeks to 1 month after surgery. Study involved 3 treatment groups: One with 30 eyes of 15 patients, corneal flaps were created with the microkeratome femtosecond laser 15 KHz 100μm (Intralase Corp, Irvine, Calif.), one with 30 eyes of 15 patients, corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif) and one with 26 eyes of 13 patients, corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) . A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •Patients ask for LASIK surgery
- •Patients with stable refraction in the last year
- •Patients without systemic and ocular disease
- •Patients with 500 microns in pachymetry
- •Normal topography
排除标准
- •Patients cannot attend their appointments
- •Residual, recurrent or active ocular disease
- •Previous ocular surgery except LASIK
- •Autoimmune or connective tissue disease
- •Pregnancy
研究组 & 干预措施
II
Corneal flaps were created with mechanical microkeratome K3000 130μm ( BD Ophthalmic Systems, Waltham, Mass) .
干预措施: LASIK (Procedure)
III
Corneal flaps were created with microkeratome femtoseconds laser (Intralase Corp, Irvine, Calif.)
干预措施: LASIK (Procedure)
I
Corneal flaps were created with mechanical microkeratome (Hansatome 160μm (Chiron Vision Corp, Claremont, Calif)
干预措施: LASIK (Procedure)
结局指标
主要结局
Measured thickness flap using Confocal microscopy study
时间窗: 14 days after LASIK
次要结局
未报告次要终点