Clinical Research Directory

Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE

Sponsor: Tongji University

Summary

This prospective observational cohort study will investigate corneal biomechanical characteristics and their relationships with corneal stromal tissue features in adult patients undergoing clinically indicated small-incision lenticule extraction (SMILE). Participants will undergo standardized preoperative examinations, including Corvis ST assessment, refraction, axial length measurement, and corneal imaging. Corneal lenticules removed during routine SMILE surgery will be collected with informed consent and linked to clinical measurements from the corresponding eye using coded identifiers. The primary objective is to compare preoperative stiffness parameter at first applanation (SP-A1) between patients with high myopia and those with non-high myopia. Secondary objectives are to characterize postoperative biomechanical changes and clinical outcomes during 12 months of follow-up. Exploratory analyses will investigate relationships between stromal tissue characteristics and clinical biomechanical measurements. Surgical eligibility, surgical parameters, and postoperative care will be determined according to routine clinical practice independently of study participation. No additional corneal tissue will be removed for research.

Official title: Corneal Biomechanical Phenotypes, Stromal Tissue Characteristics, and One-Year Postoperative Changes in Patients Undergoing SMILE: A Prospective Observational Cohort Study

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