Optimizing SMILE surgery for correcting vision problems
Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
NA · Affiliated Hospital of Nantong University · NCT06982807
This study is testing if using a new system for SMILE eye surgery can help patients see better after the procedure compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University (other) |
| Locations | 2 sites (Nantong, Jiangsu and 1 other locations) |
| Trial ID | NCT06982807 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 40 with stable refractive errors who are considering SMILE surgery.
Not a fit: Patients with a history of eye surgery, keratoconus, or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes and satisfaction for patients undergoing SMILE surgery.
How similar studies have performed: Other studies have shown promising results with similar optimization approaches in refractive surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nantong, Jiangsu and 1 other locations
- The Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (ACTIVE_NOT_RECRUITING)
- The Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: Ying Yu, professor
- Email: yuying.2009@163.com
- Phone: 86 15996621616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Refractive Surgery, Myopia, Refractive Error