Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

NCT06982807 | Recruiting DMC

• 1 other identifier: 2024-K270
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Refractive Surgery; Myopia; Refractive Error

Outcome Measures

Primary Outcomes (1)

• spherical equivalent

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

  preoperative, postoperative 10 days, 1, 3, 6, 12 months

Secondary Outcomes (2)

• uncorrected distance visual acuity

  preoperative, postoperative 10 days, 1, 3, 6, 12 months

• corrected distance visualacuity

  preoperative, postoperative 10 days, 1, 3, 6, 12 months

Study Arms (2)

Group 4.0-VISULYZE group

EXPERIMENTAL

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

Procedure: Group 4.0-VISULYZE

traditional group

ACTIVE COMPARATOR

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

Procedure: traditional group

Interventions

Group 4.0-VISULYZE PROCEDURE

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

Group 4.0-VISULYZE group

traditional group PROCEDURE

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

traditional group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (2)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

ACTIVE NOT RECRUITING

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Ying Yu, professor

CONTACT

86 15996621616; yuying.2009@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (2)