Comparison of outcomes after SMILE using VISUMAX 800 and VISUMAX 500 for correcting myopia and myopic astigmatism: a systematic review and meta-analysis

BackgroundThe aim of this study was to compare the outcomes of correcting myopia and myopic astigmatism between small incision lenticule extraction (SMILE) surgery performed using VisuMax 500 (SMILE group) and that using VisuMax 800 (SMILE Pro group).MethodsPubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were searched up to February 2026 to identify relevant studies. The PRISMA guidelines were followed. Primary outcomes were postoperative efficacy, safety, and predictability at the end of follow-up. Secondary outcomes were the postoperative high-order aberrations (HOAs) parameters and the vector analysis parameters.ResultsA total of nine studies including 1,692 eyes were involved, with 1,036 eyes undergoing SMILE surgery, 656 eyes undergoing SMILE Pro surgery. All of the 9 selected studies were nonrandomized comparative studies (NRCSs) with the follow-up period ranged from 1 to 6 months. Compared with SMILE, SMILE Pro group had better stability of corrected vision (OR, 0.47; 95% CI, 0.25 to 0.86). As for cylinder and vector analysis, SMILE group showed a marginally greater residual cylinder than the SMILE Pro group (MD=−0.06; 95% CI, −0.13 to 0.00). There was statistically significant difference in |AE| between the two groups (MD=4.29; 95% CI, 2.34 to 6.24), suggesting that the SMILE group tended toward under-correction, while the SMILE Pro group tended toward over-correction. The post-operative UDVA, spherical equivalent (SE), and higher order aberrations and other vector analysis parameters between the two groups were not statistically significant.ConclusionsWithin the limitations of this study, we did not detect evidence of statistical difference between SMILE and SMILE Pro surgical procedures when used for the treatment of myopia and astigmatism. SMILE Pro using VISUMAX 800 provided more accurate refractive cylinder outcomes. Further multicentre studies with larger sample sizes and longer follow-up are warranted to confirm VisuMax 800 system superior practical benefits in surgical workflow, refractive outcomes and patient comfort.