RecruitingNot ApplicableNCT06982807

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors


Sponsor

Affiliated Hospital of Nantong University

Enrollment

600 participants

Start Date

Nov 1, 2024

Study Type

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

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Group 4.0-VISULYZE and a procedure called traditional group for people with myopia; refractive error and refractive surgery. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGroup 4.0-VISULYZE

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

PROCEDUREtraditional group

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


Locations(2)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT06982807


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