Post-approval Study of New Enrolment Patients Undergoing Bilateral Treatment With the VisuMax SMILE Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 7
- 主要终点
- Development of clinically relevant visual symptoms via questionnaire responses
研究概览
简要总结
The objective of the post-approval study (PAS) is to assess patient experience of visual symptoms 6 months after bilateral treatment with the VisuMax SMILE procedure as measured by a patient questionnaire.
详细描述
This is a prospective, multicenter, single arm, open-label, observational study of newly enrolled patients undergoing bilateral treatment with the approved SMILE procedure for the reduction or elimination of myopia with astigmatism. Patients complete a self-administered patient questionnaire preoperatively and 6 months postoperatively. Each patient's preoperative status is serving as the control for postoperative endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible for the approved VisuMax SMILE procedure according to the Professional Use Information, i.e.
- •Spherical refractive error (in minus cylinder format) from -1.00 D through -10.00 D;
- •Refraction spherical equivalent not greater in magnitude than 10.00 D;
- •Minimum age of 22 years;
- •Documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.
- •Good candidate for SMILE based on the surgeon's assessment of medical and ophthalmic health, cognitive function, and physical and social limitations
- •Intended bilateral SMILE treatment for the correction of myopia with astigmatism (-0.75 to -3.00 D)
- •Both eyes targeted for the full distance manifest spherocylindrical refraction
- •Fluent English in speaking and reading
- •Willingness and ability to return for 6-month postoperative examination
- •Signed informed consent
排除标准
- •Presence of any of the contraindications of the approved SMILE procedure for the reduction or elimination of myopia with astigmatism, i.e.
- •a residual stromal bed thickness that is less than 250 microns from the corneal endothelium;
- •abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration;
- •ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect);
- •irregular or unstable (distorted/not clear) corneal mires on central keratometry images;
- •severe dry eye;
- •active eye infection or inflammation;
- •recent herpes eye infection or problems resulting from past infection;
- •active autoimmune disease or connective tissue disease;
- •uncontrolled diabetes;
- •uncontrolled glaucoma.
- •Previous treatment with any form of refractive surgery
结局指标
主要结局
Development of clinically relevant visual symptoms via questionnaire responses
时间窗: 6 months
* Proportion of subjects that developed "very" or "extremely" bothersome visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction) * Proportion of subjects that developed difficulty performing daily activities (2 highest categories) due to visual symptoms from preoperative (with optical correction) to 6 months postoperatively (without optical correction)
次要结局
- Development and resolution of all visual symptoms via questionnaire responses(6 months)
- Satisfaction via questionnaire responses(6 months)
- Resolution of clinically relevant visual symptoms via questionnaire responses(6 months)
- Dry eye via questionnaire responses(6 months)