Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- spherical equivalent
研究概览
简要总结
The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.
In this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.
The investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- •Age: 18 to 40 years old;
- •Optimal preoperative corrected visual acuity ≥4.8;
- •More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- •Patients who are willing to perform SMILE surgery
排除标准
- •Patients with history of eye surgery and trauma;
- •Patients with keratoconus tendency;
- •systemic connective tissue diseases and autoimmune diseases;
- •Patients with high blood pressure, diabetes and heart disease history;
- •Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
- •Patients with scar constitution.
结局指标
主要结局
spherical equivalent
时间窗: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.
次要结局
- uncorrected distance visual acuity(preoperative, postoperative 10 days, 1, 3, 6, 12 months)
- corrected distance visualacuity(preoperative, postoperative 10 days, 1, 3, 6, 12 months)