Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 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.
研究组 & 干预措施
LenSx
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
干预措施: Femtosecond Laser System (Device)
LenSx
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
干预措施: LASIK surgery (Procedure)
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
- Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op(Month 1, Month 3 postoperative)
- 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)
- Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative(Month 1, Month 3 postoperative)
- 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)