Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Launched by AFFILIATED HOSPITAL OF NANTONG UNIVERSITY · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new system called SMILE 4.0-VISULYZE, which aims to improve outcomes for patients undergoing a specific type of eye surgery known as Small Incision Lenticule Extraction (SMILE). The goal is to find the best settings for the surgery to help people see better after the procedure. Participants in the trial will be divided into two groups: one will receive the standard treatment based on previous experiences, while the other will use the new SMILE 4.0-VISULYZE system to fine-tune their surgery.

To be eligible for this trial, participants should be between 18 and 40 years old, have stable vision for the past two years, and be willing to undergo the SMILE surgery. They should also have good corrected vision before the surgery and must have stopped wearing contact lenses for a specific amount of time before the procedure. Throughout the trial, patients will be monitored for their vision improvement at various times after surgery, helping to determine how effective and safe the new system is for treating vision problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
• • 2. Age: 18 to 40 years old;
• • 3. Optimal preoperative corrected visual acuity ≥4.8;
• • 4. More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
• • 5. Patients who are willing to perform SMILE surgery
• Exclusion Criteria:
• • 1. Patients with history of eye surgery and trauma;
• • 2. Patients with keratoconus tendency;
• • 3. systemic connective tissue diseases and autoimmune diseases;
• • 4. Patients with high blood pressure, diabetes and heart disease history;
• • 5. Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
• • 6. Patients with scar constitution.