Abstract
BackgroundSmall incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively.Methods/DesignSingle tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye.DiscussionThis novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice.Trial registrationClinicaltrials.gov NCT01216475.
Highlights
Small incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx)
This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established Laser in-situ keratomileusis (LASIK) for myopia, providing evidence for translation into clinical practice
As we do not expect to see a great improvement to the results from the already established LASIK, we aim to demonstrate that SMILE is just as good in terms of visual outcome in this randomized non-inferiority trial
Summary
Small incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). The advantages of LASIK include early postoperative improvement and stabilization of visual acuity, minimal postoperative patient discomfort, and the possibility of enhancement in the future [1]. Side effects such as dry eyes, Femtosecond lasers have been widely used in LASIK to fashion a corneal flap, which is followed by corneal ablation using a separate excimer laser [4]. Small incision lenticule extraction (SMILE) is a variation of ReLEx that requires no retractable flap, reducing surgical time, reduced patient inconvenience from moving from one laser to another, and, potentially, more accurate ablation [8]
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