Actively Recruiting
Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
Led by Affiliated Hospital of Nantong University · Updated on 2025-05-28
600
Participants Needed
2
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The diopter is relatively stable with an increase within -0.50D per year for 2 consecutive years
- Age between 18 and 40 years old
- Optimal preoperative corrected visual acuity of 4.8 or better
- Worn soft contact lenses for more than 2 weeks or hard contact lenses for more than 3 months before surgery
- Willing to undergo SMILE surgery for refractive error correction
You will not qualify if you...
- History of eye surgery or trauma
- Presence or tendency of keratoconus
- Systemic connective tissue or autoimmune diseases
- History of high blood pressure, diabetes, or heart disease
- History of other eye diseases such as uveitis, scleritis, or inflammation
- Scar constitution
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Active, Not Recruiting
2
The Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
Y
Ying Yu, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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