Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Myopia; Refractive Error; Refractive Surgery

Treatments: Procedure: traditional group; Procedure: Group 4.0-VISULYZE

Study type: Interventional

Funder types: Other

Identifiers

NCT06982807

2024-K270

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Group 4.0-VISULYZE group

Experimental group

Description:

The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE

Treatment:

Procedure: Group 4.0-VISULYZE

traditional group

Active Comparator group

Description:

The traditional group had their infusion rates based on past experience.

Treatment:

Procedure: traditional group