A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mean Postoperative Spherical Aberration
研究概览
简要总结
The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.
详细描述
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or VSS-Rx1 OPM software.
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
- Single (Participant)
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
- •Male or female at least 18 years of age at the time of preoperative exam
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
- •Demonstration of refractive stability
- •Anticipated postoperative stromal bed thickness of at least 250 microns
- •Willing and able to return for all study examinations
排除标准
- •Pregnant, breast-feeding, or intend to become pregnant over the course of the study
- •Concurrent use of topical or systemic medications that may impair healing
- •History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
- •Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
- •Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course
结局指标
主要结局
Mean Postoperative Spherical Aberration
时间窗: 3 months
Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.
Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity
时间窗: 3 Months
Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity
次要结局
未报告次要终点