NCT02575911已完成不适用
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
研究概览
简要总结
The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
- •Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
- •If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
- •Willing and able to return for ALL scheduled follow-up examinations;
- •Willing and able to provide written informed consent;
- •Eligible for bilateral LASIK procedures to be done on the same day;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
- •Known sensitivity to planned study concomitant medications;
- •Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
- •Irregular astigmatism, based on the Investigator's judgement;
- •Pregnant, lactating or planning to become pregnant during the course of the study;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
时间窗: Month 3 postoperative
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
次要结局
- Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative(Month 1, Month 3 postoperative)
- Ease of Flap Dissection at Day 0, Operative Day(Day 0, operative day)
- Stromal Bed Quality at Day 0, Operative Day(Day 0, operative day)
- Opaque Bubble Layer (OBL) at Day 0, Operative Day(Day 0, operative day)
- Best Corrected Distance Visual Acuity (BCDVA) by Visit(Baseline, Month 1, Month 3 postoperative)
- Manifest Refraction Spherical Equivalent (MRSE)(Baseline, Month 1, Month 3 postoperative)
- Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative(Month 1 postoperative)
- Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative(Month 1, Month 3 postoperative)
- Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op(Month 1, Month 3 postoperative)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Femto-flap Versus SBK Flap,Predictability and VariabilityRefractive ErrorsRefractive SurgeryNCT04684888Suzan A Rattan50
已完成
不适用
A Study of Flap Thickness Results Using the Carriazo Pendular Microkeratome - 130 Micrometers Head.Corneal Flap Thickness (Micrometers)NCT01298089Democritus University of Thrace131
终止
不适用
Corneal Flap Thickness Planed vs Measured After LASIK by Using Tree Different Systems CutRefractive ErrorsNCT00558324Asociación para Evitar la Ceguera en México43
已完成
不适用
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200MyopiaNCT05501795Stephen Wexler58
已完成
不适用
LASIK Flap Thickness and Visual Outcomes Using the WaveLight FS200 Femtosecond LaserMyopiaNCT02060461The Cleveland Clinic33