Randomized Clinical Trial Comparing Smartsight Versus Femtosecond Lasik In Myopia And Myopic Astigmatism
Published 2026 - 44th Congress of the ESCRS
Reference: PP10.01 | Type: Free paper | DOI: 10.82333/8p9z-q572
Authors: Dr Nicolás Kahuam-López* 1 , Dr Mauricio Muleiro-Alvarez 1 , Dr Guillermo Raul Vera-Duarte 1 , Dr Eber A. Medina-Estrada 1 , Dr Alejandra Botero-Benítez 1 , Dr Arturo Ramirez-Miranda 1 , Dr Enrique L. Graue-Wiechers 1 , Dr Alejandro Navas 1 , Dr Enrique O. Graue-Hernandez 1
1Cornea and Refractive Surgery,Instituto de Oftalmologia Conde de Valenciana,Mexico City,Mexico
Purpose
To compare the safety, efficacy, and refractive predictability of SmartSight versus FS-LASIK for the treatment of myopia and myopic astigmatism. This randomized clinical trial is registered at ClinicalTrials.gov (NCT06477081).
Setting
Cornea and Refractive Surgery Department, Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico.
Methods
In this ongoing randomized clinical trial, participants were allocated to SmartSight or FS-LASIK. Postoperative evaluations were performed at day 1, week 1, and months 1, 3, 6, and 12. The primary outcome was uncorrected distance visual acuity (UDVA). Secondary outcomes included spherical equivalent (SE), corrected distance visual acuity (CDVA), loss of ≥2 lines of CDVA, proportion of eyes within ±0.50 D of target refraction, dry eye symptoms, and adverse events.
Results
A total of 142 eyes were randomized (SmartSight, n=74; FS-LASIK, n=68). Mean age was 28.0 ± 4.8 and 29.4 ± 6.3 years, respectively. Both groups were comparable at baseline, with no significant differences in preoperative UCVA (logMAR 1.04 ± 0.39 vs 0.97 ± 0.38), BCVA, sphere, cylinder, spherical equivalent (–3.81 ± 1.36 vs –3.76 ± 1.66 D), OSDI score, or higher-order aberrations (all p>0.05).
At postoperative day 1, week 1, and months 1, 3, and 6, no statistically significant differences were observed in visual outcomes between groups (all p>0.05). At 6 months, 93% of eyes in the SmartSight group and 96% in the FS-LASIK group achieved UCVA of 20/20. Additionally, 93% and 96% of eyes, respectively, were within ±0.50 D of the intended SE.
Conclusions
SmartSight demonstrated visual, refractive, and safety outcomes comparable to FS-LASIK for the correction of myopia and myopic astigmatism. Both techniques showed high efficacy and predictability at 6 months. Further long-term follow-up is warranted to confirm refractive stability and safety over time.