Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Residual Refractive Cylinder
研究概览
简要总结
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction.
详细描述
The objective of the current study is to prospectively evaluate 3-month clinical outcomes from LASIK performed using the Phorcides surgical planning software with Contoura topography-guided ablation in both eyes of subjects with myopia and myopic astigmatism seeking refractive surgery for distance correction. Data will be compared to published results for wavefront optimized LASIK and LASIK performed with Contoura using other refractive algorithms.
The hypothesis is that use of the Phorcides planning software will result in a higher percentage of eyes with residual refractive cylinder ≤ 0.25D than will be achieved with wavefront-optimized (WFO) LASIK. It is also expected that unaided postoperative visual acuity and visual symptoms will be improved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidate for Contoura excimer laser vision correction
- •Gender: males and females.
- •Age: 20 or older
- •Willing and able to provide written informed consent for participation in the study.
- •Willing and able to comply with scheduled visits and other study procedures.
- •Good ocular health, with no pathology that compromises visual acuity (other than refractive error)
- •Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye being treated
- •Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D
- •Desire good vision at distance in both eyes
排除标准
- •Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, Fuchs' dystrophy, etc.)
- •Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or corneal transplant, DSAEK, DMEK, lamellar keratoplasty)
- •Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- •Desire for good uncorrected near vision in one or both eyes
- •Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial
- •Unsuitability for the trial, in the opinion of the investigator, for any reason
- •Pregnancy or desire to become pregnant during the trial
- •Intraoperative complications.
结局指标
主要结局
Residual Refractive Cylinder
时间窗: 3 months postop
Residual refractive cylinder in diopters
次要结局
- Uncorrected Distance Visual Acuity(3 months postop)
- Residual Refractive Sphere(3 months postop)
- Satisfaction and Vision(3 months postop)