Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Affiliated Hospital of Nantong University600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

600

Conditions

Refractive Surgery Myopia; Refractive Error

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

spherical equivalent

Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.

Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months

Secondary Outcomes

uncorrected distance visual acuity

Use a standardized visual acuity chart (e.g., Snellen or LogMAR chart)

Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months

corrected distance visualacuity

Use autorefractor-keratometer and phoroptor

Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts