Long-term follow-up of SMILE-derived corneal stromal lenticules preserved in nutrient capsules for treating corneal diseases.

Purpose: To investigate the long-term safety and efficacy of using keratorefractive lenticule extraction (KLEx)-derived corneal stromal lenticules preserved in nutrient capsules for the treatment of corneal diseases.

Setting: Eye and ENT Hospital of Fudan University.

Design: Observational study.

Methods: Ten eyes of 10 patients with corneal diseases (6 males, 4 females, age 38.10 ± 9.11 years, ) were treated with phototherapeutic keratectomy combined with epikeratophakia or intrastromal keratoplasty using KLEx-derived lenticules. Corneal stromal lenticules which used for transplantation was extracted from healthy myopia patients and stored in nutrient capsules at 4 °C for 28 days. Patients underwent slit-lamp microscopy, uncorrected and corrected distance visual acuity (CDVA), subjective refraction, corneal topography, and anterior segment optical coherence tomography evaluations preoperative and were followed-up at 1-week, 1-month, 3-months, and 1-year postoperatively.

Results: No complications occurred intra- or postoperatively. CDVA increased by at least two lines in seven eyes and by one line in one eye, while remaining unchanged in two eyes, by the final follow-up. There was no significant difference found in the comparison of each postoperative corneal thickness to preoperative measure. The lenticules maintained a good degree of transparency 1-year post-operatively and adhered closely to the adjacent tissue. Intraocular pressure remained stable from preoperatively to all points postoperatively. There was no significant difference in corneal endothelial cell density values between pre and all post-operative time points.

Conclusion: KLEx-derived corneal stromal lenticules preserved in nutrient capsules for up to 28 days can be safely and effectively utilized as allografts for the treatment of corneal diseases, demonstrating favorable long-term outcomes.