Clinical Investigation of the WaveLight® Ultraviolet Femtosecond Laser for Corneal Flap Creation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)
研究概览
简要总结
The purpose of this study is to see how safe the WaveLight Ultraviolet Femtosecond Laser, Model 1026 (UV fs-Laser), is for creating corneal flaps during laser-assisted in situ keratomileusis (LASIK) surgery. This study will be conducted in Australia.
详细描述
Subjects who qualify to participate will have both eyes treated. Each subject will be randomly assigned to 1 of 2 topical anesthetics (numbing eye drops) and each eye will be randomly assigned to either the UV fs-Laser or the WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
Subjects will attend a total of 6 scheduled study visits, including a preoperative Screening Visit (Day -45 to -1), a Surgery Visit (Day 0), and 4 postoperative visits at Day 1, Week 1, Month 1, and Month 3/exit, for a total individual duration of participation of approximately 4 months.
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
- •Eligible for LASIK treatment;
- •Myopia as specified in the protocol;
- •Uncorrected distance visual acuity of greater than or equal to 0.30 logMAR;
- •Best corrected distance visual acuity of less than or equal to 0.10 logMAR;
- •Presence of clear natural lens (non-cataractous eye);
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •An active implanted device for which laser use may be a contraindication;
- •Previous ocular surgery;
- •Ocular conditions that may affect subject safety or impact study outcomes;
- •Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
- •Current use of medications with known ocular side effects and photosensitivity;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
干预措施: IR fs-Laser (Device)
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
干预措施: Anesthetic 1 eye drops (Device)
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
干预措施: LASIK Surgery (Procedure)
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
干预措施: Anesthetic 2 eye drops (Device)
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
干预措施: IR fs-Laser (Device)
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
干预措施: UV fs-Laser (Device)
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
干预措施: IR fs-Laser (Device)
UV fs-Laser/Anesthetic 2 Right, IR fs-Laser/Anesthetic 2 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 2 eye drops
干预措施: Anesthetic 2 eye drops (Device)
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
干预措施: LASIK Surgery (Procedure)
UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
干预措施: UV fs-Laser (Device)
UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
干预措施: IR fs-Laser (Device)
UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
干预措施: Anesthetic 1 eye drops (Device)
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
干预措施: LASIK Surgery (Procedure)
UV fs-Laser/Anesthetic 1 Left, IR fs-Laser/Anesthetic 1 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 1 eye drops
干预措施: UV fs-Laser (Device)
UV fs-Laser/Anesthetic 2 Left, IR fs-Laser/Anesthetic 2 Right
LASIK surgery performed with the UV fs-Laser (left eye) and IR fs-Laser (right eye) as randomized with Anesthetic 2 eye drops
干预措施: UV fs-Laser (Device)
UV fs-Laser/Anesthetic 1 Right, IR fs-Laser/Anesthetic 1 Left
LASIK surgery performed with the UV fs-Laser (right eye) and IR fs-Laser (left eye) as randomized with Anesthetic 1 eye drops
干预措施: LASIK Surgery (Procedure)
结局指标
主要结局
Difference of intended and achieved flap thickness measured at center (i.e., corneal apex)
时间窗: Month 1
Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only.
Difference of flap thickness measured between central (i.e., corneal apex) and periphery (i.e., 3 millimeter radius)
时间窗: Month 1
Optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures, will be used to measure the thickness of the cornea. This endpoint is pre-specified for the UV fs-Laser only.
Ability to lift flap at time of surgery
时间窗: Day 0 Surgery
The surgeon will record a response on a questionnaire indicating ability to lift the corneal flap at time of surgery (unable to lift flap / able to lift flap). This endpoint is pre-specified for the UV fs-Laser only.
Ocular adverse events (AEs) related to corneal flap creation with UV fs-Laser and IR fs-Laser
时间窗: Day 0 Surgery up through Month 3
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons. AEs pertaining to corneal flap creation that are attributable to the laser will be recorded.
Flap-related loss of best-corrected distance visual acuity (BCDVA) greater than or equal to 2 lines (greater than or equal to 10 letters logMAR) at 1 month postoperative or later
时间窗: Month 1 up to Month 3
Visual acuity will be assessed with correction in place (phoropter or trial frame) at a distance of 4 meters under well-lit conditions using letter charts.
Number of device deficiencies
时间窗: Day 0 Surgery through Month 3
A device deficiency is defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety, or performance.
次要结局
未报告次要终点