Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAffiliated Hospital of Nantong University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Group 4.0-VISULYZE
Procedure/SurgeryThe 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
traditional group
Procedure/SurgeryThe traditional group had their infusion rates based on past experience.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Group 4.0-VISULYZE groupExperimental treatment 1 intervention
Group B: traditional groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
spherical equivalent
Use autorefractor-keratometer and phoroptor to measure degree of myopia and astigmatism，then derive the spherical equivalent.
Time frame
preoperative, postoperative 10 days, 1, 3, 6, 12 monthsSecondary outcomes
1
uncorrected distance visual acuity
Use a standardized visual acuity chart (e.g., Snellen or LogMAR chart)
Time frame
preoperative, postoperative 10 days, 1, 3, 6, 12 months2
corrected distance visualacuity
Use autorefractor-keratometer and phoroptor
Time frame
preoperative, postoperative 10 days, 1, 3, 6, 12 monthsSponsors and contacts
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Source ClinicalTrials.gov