A Pilot Study of Lyophilized Decellularized Storage of SMILE-Derived Lenticules.

Abstract

Purpose: To assess the feasibility and biocompatibility of a novel approach for preserving small incision lenticule extraction (SMILE) surgery-derived lenticules by integrating decellularization and lyophilization techniques.

Methods: A total of 72 lenticules were divided into two distinct groups: the lyophilized decellularized storage group, which underwent treatment with Triton X-100 and sodium dodecyl sulfate, followed by freeze-drying and storage at -20°C for 24 hours; and the control group, which was stored in a sterile plastic vial at room temperature after extraction. Comprehensive analyses, including scanning electron and transmission electron microscopy, hematoxylin-eosin staining, transmittance measurements, and live/dead staining, were conducted on all lenticules to evaluate their preserved properties. SPSS v20.0 software (SPSS, Inc) was used for statistical analysis of quantitative data, and a P value less than .05 was considered statistically significant.

Results: Histomorphology observed that the lyophilized decellularized lenticules effectively removed cellular components while preserving the structural regularity and integrity of the collagen fibers. After rehydration, the lenticules exhibited central thickening and peripheral thinning. The optical transmittance of all rehydrated lyophilized decellularized lenticules was significantly higher than that of lyophilized ones (all P < .05), but still lower than that of fresh lenticules (all P < .05). After 20 to 30 minutes of rehydration, the optical transmittance of the lenticules exceeded 80%, and both weight and optical transmittance stabilized (all P > .05). Furthermore, in vitro biocompatibility testing revealed relatively good morphology and comparable quantity of human keratocytes, with no detection of dead cells.

Conclusions: Lyophilized decellularized storage of SMILE-derived lenticules effectively preserved the tissue morphology, optical transparency, and biocompatibility, suggesting potential for clinical application. [J Refract Surg. 2025;41(6):e542-e550.].