NCT06982807

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Refractive Surgery
• Myopia; Refractive Error

Interventions

Type	Name	Description
PROCEDURE	Group 4.0-VISULYZE	The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
PROCEDURE	traditional group	The traditional group had their infusion rates based on past experience.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-05-21
• Last updated: 2025-05-28

Locations

2 sites across 1 country: China