Abstract
Purpose: :
ReLEx® smile is a new keratorefractive procedure whereby a stromal lenticule is cut by a femtosecond laser and manually extracted through a peripheral corneal tunnel. The purpose of this prospective quality control study is to present our initial clinical experience with ReLEx smile for treatment of moderate and high myopia.
Methods: :
379 eyes (198 patients) were treated for myopia (spherical equivalent (SE) ranging from -13.13 to -1.63 D, mean -7.28 D) with ReLEx smile and prospectively followed for 3 months. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), spherical equivalent (SE), proportion of eyes within ± 0.5/1.0 D, loss/gain of lines of CDVA, patient satisfaction, and complications were registered.
Results: :
In total, 332 eyes completed the 3-month follow up. For eyes with emmetropia as target refraction, 83% had an UDVA of ≥20/25 (logMAR ≤0.1) at day 1 after surgery, increasing to 91% at 3 months. Nine eyes lost ≥ 2 lines of CDVA, and 42 eyes lost 1 line of CDVA. Loss of CDVA was primarily caused by interface scatter, and occurred mainly during treatment of the initial 100 eyes. Two eyes gained 2 lines, and 53 eyes gained 1 line of CDVA at the 3-month follow-up. Comparing attempted vs. achieved correction, the proportion of eyes within ± 0.50 D was 77.1 %, and 94.3% were within ± 1.0 D. The difference in attempted vs. achieved SE correction was -0.13 ± 0.49 D (range 1.50 to -1.88 D). Ninety-five percent of the patients would recommend refractive surgery to others.
Conclusions: :
ReLEx smile is a flapless all-in-one femtosecond laser refractive procedure. Refractive predictability, safety and patient satisfaction at 3 months seems equal to ReLEx flex and FS-LASIK. Optimizing laser energy settings and surgeon experience is important to minimize initial inferior results.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01481792
Keywords: refractive surgery: other technologies • clinical (human) or epidemiologic studies: outcomes/complications • laser