A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Stromal Bed Surface Quality
研究概览
简要总结
The study is a prospective, open-label, comparative study design that was chosen for the purpose of optimizing the Cheetah settings, and evaluating the Cheetah system quality of LASIK flap.
详细描述
This study is a 3-month, prospective, multicenter, open-label, comparative, randomized (1:1 ratio for right and left eyes) study.
The study will be conducted at up to 5 sites and up to 300 treated subjects to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.
Both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed:
A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the two piece PI) on the other eye. The eye treated with the Cheetah femtosecond laser will be the study eye and the eye treated with the commercial iFS femtosecond laser will be the control eye.
All procedures will be performed to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The study eye will be randomized (ratio of 1:1 for right eye and left eye).
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
- •To be considered for enrollment of the study, subject must:
- •Sign an informed consent and HIPAA authorization
- •Be at least 18 years of age at the time of study exam
- •Have refractive error and be eligible for commercial LASIK treatment
- •Be available for all scheduled follow-up visits (see below)
排除标准
- •Subject will not be eligible to take part of the study if subject, use or have:
- •Known to be pregnant, breastfeeding or intend to become pregnant during the study.
- •Recent ocular (eye) trauma or eye surgery
- •A history of or active ophthalmic (eye) disease or abnormality
- •Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions
- •A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis.
- •Cardiac pacemaker, implanted defibrillator or other implanted electronic device
- •Taking systemic or inhaled medications that may affect wound healing
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the study
- •Desire for monovision correction
- •Participating in any other clinical study
研究组 & 干预措施
Control/Investigational
Both eyes of each subject will be treated. The investigators will use the commercial Cheetah femtosecond laser and Cheetah two piece PI on one eye, and commercial Cheetah femtosecond laser and investigational Cheetah to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).
Subjects will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).
干预措施: Cheetah femtosecond laser and cheetah patient interface (Device)
Investigational/Control
Both eyes of each subject will be treated. The investigators will use the investigational Cheetah femtosecond laser and Cheetah PI on one eye, and commercial iFS femtosecond laser and PI on the other eye to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The eye to receive Cheetah flap will be randomized (ratio of 1:1 for right eye and left eye).
Subjects will undergo refractive correction via corneal ablation on both eyes using a commercial excimer laser for vision correction (same excimer laser system will be used on both eyes).
干预措施: IntraLase iFS femtosecond laser and patient interface (Device)
结局指标
主要结局
Stromal Bed Surface Quality
时间窗: At the Operative visit, one time visit
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher.
次要结局
未报告次要终点