Status:
RECRUITING
Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Refractive Surgery
Myopia; Refractive Error
Eligibility:
All Genders
18-40 years
Phase:
NA
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-V...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06982807
Start Date
November 1 2024
End Date
December 31 2026
Last Update
May 28 2025
Active Locations (2)
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1
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
2
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001