Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ease of Lifting Flaps
研究概览
简要总结
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.
Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.
Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
- •Must be over 18 years of age
- •Must have visual acuity correctable to at least 20/25 in both eyes
- •If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
- •Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
- •Must sign and be given a copy of the written Informed Consent form
- •Postoperative refractive target is emmetropia
排除标准
- •Known sensitivity to planned study concomitant medications
- •Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
- •Presenting any contraindications to femtosecond initiated LASIK
- •Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
- •Irregular astigmatism, based on Investigator's judgment
- •Undergoing monovision LASIK
- •Pregnant, lactating or plan to become pregnant during the course of this study
- •For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.
结局指标
主要结局
Ease of Lifting Flaps
时间窗: Operative
0 - Unable to lift flap 1. - Able to lift flap with aid of sharp instrument 2. - Able to lift flap with difficulty using blunt instrument 3. - Able to lift flap with moderate resistance using blunt instrument 4. - Able to lift flap with minimal resistance using blunt instrument 5. - Able to lift flap without any resistance using blunt instrument (Scale)
次要结局
- Stromal Bed Quality(Operative)