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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimization of surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) surgery to correct refractive errors such as myopia. This study compares the traditional method based on past experience with a new system called SMILE 4.0-VISULYZE, which uses a regression model to adjust input parameters. The goal is to achieve better postoperative visual outcomes, including improved uncorrected and best-corrected visual acuity, spherical power, cylindrical power, and spherical equivalent. Patients scheduled for SMILE surgery will be divided into two groups: one where infusion rates are adjusted using the SMILE 4.0-VISULYZE system and another where adjustments are made based on historical experience. The study will monitor these groups over time to compare results at multiple points post-surgery, including 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year. The study aims to assess the effectiveness and safety of the SMILE 4.0-VISULYZE system in treating refractive errors. Participants will undergo assessments of their visual acuity and refractive measurements before surgery and at several follow-up visits up to one year after surgery. The primary outcome is the spherical equivalent measured preoperatively and at 10 days, 1, 3, 6, and 12 months after surgery. Secondary outcomes include uncorrected and corrected distance visual acuity measured at the same time points. This study is conducted with ongoing monitoring to evaluate both efficacy and safety of the surgical methods.
CONDITIONS
Brief 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 (the diopter increases 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
- Stopped wearing soft contact lenses for more than 2 weeks and hard contact lenses for more than 3 months before surgery
- Willing to undergo SMILE surgery
You will not qualify if you...
- History of eye surgery or trauma
- Tendency toward keratoconus
- Systemic connective tissue diseases or autoimmune diseases
- History of high blood pressure, diabetes, or heart disease
- History of other eye diseases such as uveitis, scleritis, or other eye inflammations
- Scar constitution
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo SMILE surgery with infusion rates calibrated either by 4.0-VISULYZE or based on past experience.
1 surgery visit and immediate post-operative care
Duration - 12 months
Participants are monitored for recovery and visual acuity at multiple timepoints after surgery.
Visits at 10 days, 1 month, 3 months, 6 months, and 12 months post-operation
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
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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