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New treatment option for Refractive Surgery
Official title Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
ClinicalTrials.gov ID: NCT06982807
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);
- Age: 18 to 40 years old;
- Optimal preoperative corrected visual acuity ≥4.8;
- More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery
- Patients who are willing to perform SMILE surgery
You likely can't join if
- Patients with history of eye surgery and trauma;
- Patients with keratoconus tendency;
- systemic connective tissue diseases and autoimmune diseases;
- Patients with high blood pressure, diabetes and heart disease history;
- Other eye disease history such as uveitis, scleritis and other eye inflammation patients;
- Patients with scar constitution.
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.