Abstract:AIM: To evaluate the efficacy and safety of scleral lenses (SLs) in patients with keratoconus. METHODS: Electronic databases including PubMed, Scopus, Web of Science, Embase, and Cochrane Library were systematically searched to find the articles on visual function and patient satisfaction following SLs fitting. A random-effects model was applied to specify the pooled values. RESULTS: Of 833 studies, 19 articles (704 eyes) and 14 studies (475 eyes) were included in qualitative and quantitative synthesis, respectively. Pooled mean difference (PMD) of best corrected visual acuity (BCVA) was -0.37 [95% confidence interval (CI), -0.48 to -0.26] logMAR in favor of SLs treatment. SLs markedly reduced ocular and corneal higher-order aberrations and increased the quality of vision. The overall pooled values for comfort, visual quality and patient satisfaction with SLs were 4.19 (95%CI, 3.83 to 4.55), 4.30 (95%CI, 3.97 to 4.64), and 80.83% (95%CI, 71.54% to 90.13%), respectively. The most reported complications were lens breakage (26.1%) and conjunctival injection (11.4%–15.8%). CONCLUSION: SLs fitting leads to improved visual outcomes and patient satisfaction in patients with keratoconus.