Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Affiliated Hospital of Nantong University
RECRUITING
Nantong
The Affiliated Hospital of Nantong University
ACTIVE_NOT_RECRUITING
Nantong
Contact Information
Primary
Ying Yu, professor
yuying.2009@163.com
86 15996621616
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 600
Treatments
Experimental: Group 4.0-VISULYZE group
The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
Active_comparator: traditional group
The traditional group had their infusion rates based on past experience.
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov