Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Not Applicable

Recruiting

• Conditions: Refractive Surgery; Myopia; Refractive Error

• Registration Number: NCT06982807
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief 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 our 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.

We 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, we 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
spherical equivalent	preoperative, postoperative 10 days, 1, 3, 6, 12 months	Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.

Secondary Outcome Measures

Name	Time	Method
uncorrected distance visual acuity	preoperative, postoperative 10 days, 1, 3, 6, 12 months	Use a standardized visual acuity chart (e.g., Snellen or LogMAR chart)
corrected distance visualacuity	preoperative, postoperative 10 days, 1, 3, 6, 12 months	Use autorefractor-keratometer and phoroptor

Trial Locations

Locations (1)

The Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China