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Clinical Outcomes of Small Incision Lenticule Extraction in Myopia: Study of Vector Parameters and Corneal Aberrations

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Clinical Outcomes of Small Incision Lenticule Extraction in Myopia: Study of Vector Parameters and Corneal Aberrations Korean J Ophthalmol 2020;34(1):76-84 https://doi.org/10.3341/kjo.2019.0109 pISSN: 1011-8942 eISSN: 2092-9382 Original Article Clinical Outcomes of Small Incision Lenticule Extraction in Myopia: Study of Vector Parameters and Corneal Aberrations Jay Jiyong Kwak1, Ikhyun Jun1, Eung Kweon Kim1,2, Kyoung Yul Seo1, Tae-Im Kim1,2 1Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Korea 2Corneal Dystrophy Research Institute, Severance Biomedical Science Institute, and Brain Korea 21 Project for Medical Science, Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Korea Purpose: To investigate clinical outcomes of small incision lenticule extraction (SMILE) including vector parame- ters and corneal aberrations in myopic patients. Methods: This retrospective, observational case series included 57 eyes (29 patients) that received treatment for myopia using SMILE. Visual acuity measurement, manifest refraction, slit-lamp examination, autokeratome- try, corneal topography, and evaluation of corneal wavefront aberration were performed preoperatively and at 1 and 3 months after surgery. We analyzed the safety, efficacy, vector parameters, and corneal aberrations at 3 months after surgery. Results: Preoperatively, mean manifest refraction spherical equivalent refraction was -4.94 ± 1.94 D (range, -8.25 to 0 diopters [D]), and the cylinder was -1.14 ± 0.82 D (range, -3 to 0 D). Mean manifest refraction spher- ical equivalent improved to -0.10 ± 0.23 D at 3 months postoperatively, when uncorrected distance visual acu- ity was 20 / 20 or better in 55 (96%) eyes. The linear regression model of target induced astigmatism vector versus surgically induced astigmatism vector exhibited slopes and coefficients (R2) of 0.9618 and 0.9748, re- spectively (y = 0.9618x + 0.0006, R2 = 0.9748). While total corneal root mean square higher order aberrations, coma and trefoil showed statistically significant increase, spherical aberration did not show statistically signifi- cant change after SMILE. Conclusions: SMILE has proven to be effective and safe for correcting myopia and astigmatism. We showed that SMILE did not induce spherical aberrations. A small increase in postoperative corneal higher order aber- ration may be associated with increase in coma and trefoil. Key Words: Astigmatism, Corneal wavefront aberration, Refractive surgical procedures, Small incision lenticule extraction, Vector analysis Received: August 29, 2019 Final revision: September 5, 2019 Since Jose Barraquer invented keratomileusis for correc- Accepted: October 17, 2019 tion of high myopia in 1949, researchers have combined Corresponding Author: Tae-Im Kim, MD, PhD. Institute of Vision Re- keratomileusis with excimer laser surface ablation to de- search, Department of Ophthalmology, Severance Hospital, Yonsei Uni- versity College of Medicine, 50 Yonseri-ro, Seodaemun-gu, Seoul 03722, velop one of the most commonly used laser corneal refrac- Korea. Tel: 82-2-2228-3574, Fax: 82-2-312-0541, E-mail: [email protected] tive surgery techniques, laser in situ keratomileusis The abstract was presented at the 119th Annual Meeting of the Korean (LASIK) [1]. Creation of a corneal flap allows early visual Ophthalmological Society in Busan, Korea, April 7-8, 2018. recovery, less discomfort, and reduced stromal inflamma- © 2020 The Korean Ophthalmological Society This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses /by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 76 JJ Kwak, et al. Clinical Outcome of SMILE 1 tion. However, this procedure can induce loss of corneal Materials and Methods biomechanical strength and worsen dry eye [2]. Surface ablation laser surgery is another type of corneal refractive Patients surgery. Unlike LASIK, surface ablation does not create a flap but uses an excimer laser to expose and remove the This study was a retrospective, observational case series corneal stroma after removing the corneal epithelium by approved by the institutional review board of Yonsei Uni- mechanical scraping (photorefractive keratectomy) or 20% versity College of Medicine, Seoul, South Korea (4-2019- alcohol (laser epithelial keratomileusis) [2]. Without the 0521). The study followed the tenets of the Declaration of flap, surface ablation results in a biomechanically stronger Helsinki. Written informed consent was waived due to the cornea compared to that of LASIK. Technological ad- retrospective nature of the study. Patients enrolled in this vancements have allowed incorporation of wavefront tech- study received treatment by SMILE from a single experi- nology to laser refractive surgery. Wavefront-guided exci- enced surgeon (TK) at Severance Hospital, Yonsei Univer- mer laser surgery is designed to minimize surgically sity College of Medicine between January 2017 and Janu- induced higher order aberrations or compensate for pre-ex- ary 2018. This study included 57 eyes of 29 subjects who isting higher order aberrations [2]. Small incision lenticule underwent SMILE. extraction (SMILE; Carl Zeiss Meditec AG, Jena, Germa- Inclusion criteria were myopia of fewer than 9.00 diop- ny) is a relatively new flapless refractive surgery that uti- ters (D), age 20 to 45 years, and corrected distance visual lizes a femtosecond laser to create a lenticule of the desired acuity (CDVA) of 0.7 Snellen or better. Exclusion criteria correction within the cornea, which is then extracted were systemic and ocular anomalies or pathologies and through a small corneal incision. The procedure was ini- history of intraocular or corneal surgery. tially introduced as femtosecond lenticule extraction (FLEx, Carl Zeiss Meditec AG), which required creation of Examination protocol a flap similar to that in LASIK plus an additional posterior cut to create a stromal lenticule that is then extracted [3]. Preoperatively, all patients underwent complete ophthal- Surgical techniques have evolved to pseudo small-incision mologic examination, including uncorrected distance visu- lenticule and small-incision lenticule extractions, which re- al acuity (UDVA) and CDVA, manifest refraction, slit- quire no retractable flaps [2]. Small-incision lenticule ex- lamp examination, autokeratometry, noncontact tonometry, traction involves removal of the same lenticule through a funduscopy, and Scheimpflug-based corneal topography small 2.0 to 3.0 mm pocket incision, whereas pseudo (Pentacam HR; Oculus Optikgeräte, Wetzlar, Germany). small-incision lenticule extraction is generally performed Corneal wavefront aberrations were measured using iTrace during the learning curve with a bigger pocket incision (5.0 (Tracey Technology, Houston, TX, USA). Postoperatively, to 6.0 mm) that allows conversion to lifting of the flap the patients were examined for UDVA and CDVA, auto- when unsuccessful [4]. Compared to LASIK, SMILE pro- keratometry, and tonometry at 1 day, 1 week, 1 month, and vided a similar visual outcome with a lower incidence of 3 months after surgery. We performed manifest refraction flap complications and dry eye [5,6]. As a result, SMILE is and Scheimpflug-based corneal topography at 1 week, 1 becoming a promising alternative to other refractive sur- month, and 3 months after surgery. We measured corneal geries despite its shorter history. The objective of this ret- aberrations 3 months after surgery rospective study is to evaluate the clinical outcomes, in- cluding astigmatic vector parameters and corneal Surgical procedure aberrometric changes, of SMILE in myopic patients. One experienced surgeon (TK) performed all surgeries with a 500-kHz VisuMax system (Carl Zeiss Meditec AG) using standardized techniques with the three-centration point marking technique [7]. After topical anesthesia with proparacaine hydrochloride (Alcaine; Alcon, Fort Worth, TX, USA), photo disruption was used to create posterior 77 Korean J Ophthalmol Vol.34, No.1, 2020 and anterior surfaces of the lenticule and side-cut opening. Table 1. Study demographics Following use of the femtosecond laser, the surgeon used a Characteristics Value spatula to separate the refractive lenticule and extract it us- No. of eyes 57 ing forceps. We instructed patients to instill moxifloxacin Age (yr) 25.59 ± 5.49 (20 to 41) 0.5% together with loteprednol etabonate 0.5% every two Sex, male : female 18 : 11 hours for the first 24 hours and then four times a day for the following two weeks. Subsequently, we tapered medi- Refractive error (D) cations to meet each patient’s condition. All surgeries were Sphere -4.37 ± 1.98 (-7.25 to 0) uneventful, and no complications such as suction loss, Cylinder -1.14 ± 0.82 (-3 to 0) black spots, difficult dissection, incomplete separation of Spherical equivalent -4.94 ± 1.94 (-8.63 to -1) the lenticule, or epithelial ingrowth occurred in any eyes. CDVA (logMAR) -0.04 ± 0.04 (-0.08 to 0) UDVA (logMAR) 1.10 ± 0.47 (0.30 to 2) Statistical analysis IOP (mmHg) 14.68 ± 3.02 (8 to 22) Values are presented as mean ± standard deviation (range) or We presented the results as mean, standard deviation, number. and range and performed Student’s t-test to evaluate the D = diopters; CDVA = corrected distance visual acuity; logMAR = logarithm of the minimum angle of resolution; UDVA = uncor- difference between preoperative and postoperative data. rected distance visual acuity; IOP = intraocular
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