Randomized Clinical Trial Comparing Klex And Femtosecond Lasik In Myopia And Myopic Astigmatism

This study aims to compare the effectiveness and safety of KLEx and FS-LASIK as treatment options for myopia and myopic astigmatism.

This trial is registered at ClinicalTrials.gov (NCT06477081).

Cornea and Refractive Surgery Department, Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico.

This ongoing clinical trial involves participants randomized into two groups: KLEx and FS-LASIK. Postoperative evaluations are conducted on the first day after surgery, at 1 week, and 1, 3, 6, and 12 months. The primary outcome measure is uncorrected visual acuity (UCVA). Secondary outcomes include postoperative spherical equivalent (SE), best-corrected visual acuity (BCVA), loss of 2 or more lines of BCVA, percentage of eyes within ±0.5 diopters of the refractive target, dry eye, and adverse events.

Thirty eyes were randomized (KLEx=12, FS-LASIK=18). The mean age was 31 ± 7.6 (KLEx) and 30.2 ± 6.37 (FS-LASIK). Both groups had similar preoperative UCVA logMAR (1.1 ± 0.15 vs 1.0 ± 0.33), BCVA, sphere, cylinder, SE (-3.88 ± 1.66 vs -3.86 ± 2.06), OSDI, and aberrations (p>0.05). At day 1, week 1, and month 1, no significant differences were found in visual outcomes (p>0.05), except for coma, which was higher in KLEx at day 1 (0.23 ± 0.14 vs 0.12 ± 0.06, p=0.02) and lower at month 1 (0.07 ± 0.03 vs 0.13 ± 0.05, p=0.001). By month 1, both groups achieved UCVA logMAR 0.0. No significant differences were found in sphere (0.2 ± 0.2 vs 0.31 ± 0.29), cylinder, SE (0.10 ± 0.27 vs 0.06 ± 0.16), OSDI, or spherical aberration.

Preliminary results suggest that KLEx is a safe and effective treatment for myopia and myopic astigmatism, offering refractive efficacy comparable to FS-LASIK. However, long-term follow-up will be crucial in making a definitive comparison between both techniques.