Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors

Обзор

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.

Вмешательства

• Процедура Group 4.0-VISULYZE
  The 4.0-VISULYZE group had their infusion rates precisely calibrated using 4.0-VISULYZE
• Процедура traditional group
  The traditional group had their infusion rates based on past experience.

Первичные конечные точки

• spherical equivalent [Срок оценки: preoperative, postoperative 10 days, 1, 3, 6, 12 months]

Вторичные конечные точки (2)

• uncorrected distance visual acuity [Срок оценки: preoperative, postoperative 10 days, 1, 3, 6, 12 months]
• corrected distance visualacuity [Срок оценки: preoperative, postoperative 10 days, 1, 3, 6, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Affiliated Hospital of Nantong University — Nantong
• The Affiliated Hospital of Nantong University — Nantong

Публикации

• Zhao L, Gao N, Liu E, Cheng X, Li J, Ji H, Yu Y. Comparative Validation of a VISULYZE-Based Nomogram for Predicting Visual Outcomes and Higher-Order Aberrations After SMILE in High Myopia. J Ophthalmol. 2026 Jun 18;2026:1918446. doi: 10.1155/joph/1918446. eCollection 2026. PMID 42328095

Идентификаторы

NCT: NCT06982807 · 2024-K270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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