Femtosecond (FS) laser vision correction procedure for moderate to high myopia: a prospective study of ReLEx(®) flex and comparison with a retrospective study of FS-laser in situ keratomileusis.

Purpose: To present our initial clinical experience with ReLEx(®) flex (ReLEx) for moderate to high myopia. We compare efficacy, safety and corneal higher-order aberrations after ReLEx with femtosecond laser in situ keratomileusis (FS-LASIK).

Methods: Prospective study of ReLEx compared with a retrospective study of FS-LASIK. ReLEx is a new keratorefractive procedure, where a stromal lenticule is cut by a femtosecond laser and manually extracted. Forty patients were treated with ReLEx on both eyes. A comparable group of 41 FS-LASIK patients were retrospectively identified. Visual acuity, spherical equivalent (SE) and corneal tomography were measured before and 3 months after surgery.

Results: Preoperative SE averaged -7.50 ± 1.16 D (ReLEx) and -7.32 ± 1.09 D (FS-LASIK). For all eyes, mean corrected distance visual acuity remained unchanged in both groups. For eyes with emmetropia as target refraction, 41% of ReLEx and 61% of FS-LASIK eyes had an uncorrected distance visual acuity of logMAR ≤ 0.10 at day 1 after surgery, increasing to, respectively, 88% and 69% at 3 months. Mean SE was -0.06 ± 0.35 D 3 months after ReLEx and -0.53 ± 0.60 D after FS-LASIK. The proportion of eyes within ±1.00 D after 3 months was 100% (ReLEx) and 85% (FS-LASIK). For a 6.0-mm pupil, corneal spherical aberrations increased significantly less in ReLEx than FS-LASIK eyes.

Conclusions: ReLEx is an all-in-one femtosecond laser refractive procedure, and in this study, results were comparable to FS-LASIK. Refractive predictability and corneal aberrations at 3 months seemed better than or equal to FS-LASIK, whereas visual recovery after ReLEx was slower.