Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
Affiliated Hospital of Nantong University
600 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria6
- 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.
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Interventions
The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
The traditional group had their infusion rates based on past experience.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06982807