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Recruiting NCT06982807

Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

No phase Interventional Refractive Surgery Myopia; Refractive Error

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group 4.0-VISULYZE, traditional group.
Who it may be relevant to
Registry conditions: Refractive Surgery, Myopia; Refractive Error. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Interventions

  • Procedure Group 4.0-VISULYZE
    The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
  • Procedure traditional group
    The traditional group had their infusion rates based on past experience.

Primary outcome measures

  • spherical equivalent [Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months]
Secondary outcome measures (2)
  • uncorrected distance visual acuity [Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months]
  • corrected distance visualacuity [Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Affiliated Hospital of Nantong University — Nantong
  • The Affiliated Hospital of Nantong University — Nantong

Publications

  • Zhao L, Gao N, Liu E, Cheng X, Li J, Ji H, Yu Y. Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia. J Ophthalmol. 2026 Jun 18;2026:1918446. doi: 10.1155/joph/1918446. eCollection 2026. PMID 42328095

Identifiers

NCT: NCT06982807 · 2024-K270

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗