NCT06982807 Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
| NCT ID | NCT06982807 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Affiliated Hospital of Nantong University |
| Condition | Refractive Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2024-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06982807 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Refractive Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06982807 currently recruiting?
Yes, NCT06982807 is actively recruiting participants. Contact the research team at yuying.2009@163.com for enrollment information.
Where is the NCT06982807 trial being conducted?
This trial is being conducted at Nantong, China, Nantong, China.
Who is sponsoring the NCT06982807 clinical trial?
NCT06982807 is sponsored by Affiliated Hospital of Nantong University. The trial plans to enroll 600 participants.