An interventional study of Group 4.0-VISULYZE and traditional group in Refractive Surgery and Myopia; Refractive Error, sponsored by Affiliated Hospital of Nantong University. Recruiting at 2 sites in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Affiliated Hospital of Nantong University · Not applicable, Interventional, and Treatment
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 600 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Affiliated Hospital of Nantong University is the lead sponsor of 97 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
Procedure: Group 4.0-VISULYZE
The traditional group had their infusion rates based on past experience.
Procedure: traditional group
The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
The traditional group had their infusion rates based on past experience.
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 months
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 months
corrected distance visualacuity
Use autorefractor-keratometer and phoroptor
Time frame: preoperative, postoperative 10 days, 1, 3, 6, 12 months
Not enrolling at this site.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2025, 13 months after the start.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 13 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
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Affiliated Hospital of Nantong University