Corneal refractive surgery disrupts corneal integrity and reduces biomechanical stability in consequence of the beneficial refractive alteration. The minimal invasive cap-based refractive procedure, small-incision lenticule extraction (SMILE), has been proposed to affect corneal integrity less than flap-based procedures, due to the fibre-sparing incision of the strong anterior corneal lamellae. Flap-based procedures include laser-assisted in situ keratomileusis (LASIK), femtosecond laser-assisted in situ keratomileusis (FS-LASIK) and femtosecond lenticule extraction (FLEx). The purpose of this systematic review was to evaluate corneal biomechanical changes by noncontact air pulse tonometry after treatment of myopia/myopic astigmatism with SMILE compared to flap-based refractive surgery. A total of 220 publications were identified through a systematic search in PubMed and Embase. Two levels of screening identified nine studies (three randomised controlled trials (RCT) and six nonrandomised clinical trials) eligible for the review. All the nonrandomised clinical trials were graded to have an overall serious risk of bias. Measurements with the Corvis ST were not included in any of the eligible studies. The RCTs found no statistical significant differences between SMILE or flap-based procedures concerning corneal hysteresis (CH) or corneal resistance factor (CRF), as measured with the Ocular Response Analyzer. However, a greater reduction in CRF and CH was found in the flap-based group in five and two of the nonrandomised studies, respectively. The findings in this review illustrate that the presumed biomechanical advantages of a cap-based small incision could not be demonstrated in existing studies and by commercially available technology. However, studies with lower levels of evidence suggest less affection of corneal viscoelastic properties after SMILE when evaluating corneal stability by noncontact tonometry.

We report the first paired-eye study to directly compare Ocular Response Analyzer (ORA) derived corneal waveform parameters after the two all-femtosecond laser refractive techniques, ReLEx FLEX (FLEX) and ReLEx SMILE (SMILE). A total of 34 patients, treated with FLEX in one eye, and SMILE in the other for moderate to high myopia, were examined before and 6 months after surgery. Overall, the 37 corneal waveform parameters from the ORA were not able to detect any major differences in corneal biomechanical properties, between the flap-based FLEX procedure and the cap-based SMILE procedure.