Study Comparing SMILE 4.0-VISULYZE System Versus Traditional Method for Correcting Refractive Errors in Adults

What this Trial Is About

Researchers are evaluating the optimization of surgical input parameters for patients undergoing Small Incision Lenticule Extraction SMILE surgery to correct refractive errors such as myopia. This study compares the traditional method based on past experience with a new system called SMILE 4.0-VISULYZE, which uses a regression model to adjust input parameters. The goal is to achieve better postoperative visual outcomes, including improved uncorrected and best-corrected visual acuity, spherical power, cylindrical power, and spherical equivalent. Patients scheduled for SMILE surgery will be divided into two groups one where infusion rates are adjusted using the SMILE 4.0-VISULYZE system and another where adjustments are made based on historical experience. The study will monitor these groups over time to compare results at multiple points post-surgery, including 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year. The study aims to assess the effectiveness and safety of the SMILE 4.0-VISULYZE system in treating refractive errors. Participants will undergo assessments of their visual acuity and refractive measurements before surgery and at several follow-up visits up to one year after surgery. The primary outcome is the spherical equivalent measured preoperatively and at 10 days, 1, 3, 6, and 12 months after surgery. Secondary outcomes include uncorrected and corrected distance visual acuity measured at the same time points. This study is conducted with ongoing monitoring to evaluate both efficacy and safety of the surgical methods.

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors