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Clinical Trials in China / NCT06982807
Recruiting Not applicable

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

NCT06982807 · tracked via the Priya Life Science China tracker
Sponsor
Affiliated Hospital of Nantong University
Phase
Not applicable
Started
2024-11-01
Last updated
2025-05-28

Condition(s) studied

Refractive SurgeryMyopia; Refractive Error

Investigational drug(s) / intervention(s)

Group 4.0-VISULYZEtraditional group

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
The Affiliated Hospital of Nantong University Nantong Jiangsu Active Not Recruiting
The Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting

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Other trials for the same condition

Assessment of IOP After Corneal Refractive Surgery Based on AI Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06982807 on ClinicalTrials.gov ↗ ← All trials in China