Optimizing SMILE surgery for correcting vision problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to enhance the surgical parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) by utilizing the SMILE 4.0-VISULYZE system. Patients scheduled for SMILE surgery will be divided into two groups: one receiving traditional parameter adjustments based on historical data and the other using the advanced 4.0-VISULYZE system for optimization. The study will compare postoperative outcomes such as uncorrected and best-corrected visual acuity, as well as various refractive measurements at multiple follow-up intervals. The goal is to achieve better visual outcomes for patients undergoing this procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
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:

1. Patients with history of eye surgery and trauma;
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.

Where it's running

• The Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting
• The Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Active not recruiting

Study contacts

• Study coordinator: Ying Yu, professor
• Email: yuying.2009@163.com
• Phone: 86 15996621616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.