Refractive Outcomes And Safety Profile Of Smile Pro Lenticule Extraction: Prospective Evaluation Of 100 Eyes

Since its clinical introduction by Walter Sekundo, lenticule extraction has evolved into a key component of modern corneal refractive surgery. By preserving anterior stromal architecture and avoiding flap creation, it aims to enhance biomechanical stability while minimizing flap-related complications. This study evaluates visual outcomes, early visual rehabilitation, and refractive safety following SMILE Pro treatment over a 12-week follow-up period.

Retrospective single-center study including 100 consecutive eyes treated between June 2024 and August 2025. All procedures were performed by one experienced refractive surgeon using a standardized surgical protocol.

Preoperative assessment included manifest refraction, spherical equivalent (SE), and corrected distance visual acuity (CDVA, logMAR). Postoperative examinations were conducted at day 1, week 1, and 12 weeks. UDVA (logMAR) was recorded at each visit, and CDVA was assessed at 12 weeks. The safety index was calculated as the ratio of postoperative to preoperative CDVA. Outcomes were analyzed with respect to visual rehabilitation kinetics and refractive safety.

Mean UDVA improved rapidly, measuring 0.01 logMAR at day 1, −0.03 logMAR at week 1, and −0.05 logMAR at 12 weeks, demonstrating continuous visual optimization. No loss of CDVA was observed at final follow-up. The mean safety index was 1.1, indicating maintained or improved corrected visual acuity. Visual rehabilitation was characterized by early functional acuity with progressive enhancement over the 12-week period.

SMILE Pro demonstrated rapid visual rehabilitation, excellent uncorrected visual outcomes, and a favorable safety profile. The flapless, cap-based architecture preserves anterior lamellar stromal fibers, supporting corneal biomechanical integrity compared with flap-dependent procedures. The platform allows cap diameters up to 7.9 mm and optical zones up to 7.0 mm, enabling customized corneal geometry. A short laser treatment time (~10 seconds), simplified docking to the patient interface, and rapid lenticule preparation enhance procedural efficiency. With a mean safety index of 1.1, SMILE Pro represents an advanced biomechanically conscious evolution of lenticule-based refractive surgery with predictable outcomes and fast recovery.