Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
NCT ID: NCT06982807
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2024-11-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 4.0-VISULYZE group
The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
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.
traditional group
The traditional group had their infusion rates based on past experience.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
ALL
No
Sponsors
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Affiliated Hospital of Nantong University
OTHER
Responsible Party
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Locations
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The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-K270
Identifier Type: -
Identifier Source: org_study_id
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