Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism

Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial
Published:January 14, 2020DOI:https://doi.org/10.1016/j.ophtha.2020.01.010

      Purpose

      To present outcomes of the United States Food and Drug Administration premarket approval clinical trial of small-incision lenticule extraction (SMILE) for the correction of myopia and astigmatism.

      Design

      Prospective, multicenter clinical trial.

      Participants

      The study included 357 eyes of 357 patients treated with SMILE (50 for myopia and 307 for myopia with astigmatism). Preoperative sphere ranged between –1.00 and –10.00 diopters (D), with manifest spherical equivalent (MSE) of up to –11.50 D and refractive cylinder of up to –3.00 D.

      Methods

      -Participants were followed up for 12 months. Corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA), stability of the manifest refraction, and vector analysis of refractive cylinder are presented for the 307 eyes treated for myopia with astigmatism. Adverse events (AEs) are presented for all 357 eyes.

      Main Outcome Measures

      Corrected distance visual acuity, uncorrected distance visual acuity, manifest refraction, astigmatic outcomes, and adverse events.

      Results

      Of the 307 astigmatic eyes enrolled in the study, 304 were treated successfully. In 3 eyes, the procedure was aborted because of intraoperative suction loss. The mean MSE reduced from –5.39±2.30 D at baseline to –0.01±0.24 D at 12 months. Of all eyes, 95.3% were within 0.50 D of emmetropia at 12 months. The percentage of eyes with UDVA of 20/20 or better was 89.0%. No loss of 2 or more lines of CDVA was observed at the 12-month visit. The refractive cylinder reduced from –1.53±0.70 D at baseline to –0.18±0.31 D at 12 months. The mean correction ratio of refractive cylinder was 0.96±0.16 and a slight undercorrection was apparent for higher attempted corrections of astigmatism. Three intraoperative AEs associated with difficult lenticule removal and resultant cap tear occurred, and all resolved without sequelae at postoperative day 1. During the postoperative period, 8 AEs were recorded, but none of them had significant consequences.

      Conclusions

      Small-incision lenticule extraction for the treatment of myopia and astigmatism was safe and effective, and the reported AEs had no significant impact on visual acuity. Slight undercorrection of refractive cylinder requires further attention.

      Abbreviations and Acronyms:

      AE ( adverse event), CDVA ( corrected distance visual acuity), CR ( correction ratio), D ( diopter), EM ( error of magnitude), ER ( error ratio), EV ( error vector), FDA ( Food and Drug Administration), IRC ( intended refractive correction), MSE ( manifest spherical equivalent), PMA ( premarket approval), SIRC ( surgically induced refractive correction), SMILE ( small incision lenticule extraction), UDVA ( uncorrected distance visual acuity)
      To read this article in full you will need to make a payment
      Subscribe to Ophthalmology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Zhang Y.
        • Shen Q.
        • Jia Y.
        • et al.
        Clinical outcomes of SMILE and FS-LASIK used to treat myopia: a meta-analysis.
        J Refract Surg. 2016; 32: 256-265
        • Lee J.K.
        • Chuck R.S.
        • Park C.Y.
        Femtosecond laser refractive surgery: small-incision lenticule extraction vs. femtosecond laser-assisted LASIK.
        Curr Opin Ophthalmol. 2015; 26: 260-264
        • Reinstein D.Z.
        • Archer T.J.
        • Gobbe M.
        Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes.
        Eye Vis (Lond). 2014; 1: 3
        • Sekundo W.
        • Kunert K.S.
        • Blum M.
        Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study.
        Br J Ophthalmol. 2011; 95: 335-339
        • Shah R.
        • Shah S.
        • Sengupta S.
        Results of small incision lenticule extraction: all-in-one femtosecond laser refractive surgery.
        J Cataract Refract Surg. 2011; 37: 127-137
        • Ivarsen A.
        • Hjortdal J.
        Correction of myopic astigmatism with small incision lenticule extraction.
        J Refract Surg. 2014; 30: 240-247
        • Kobashi H.
        • Kamiya K.
        • Ali M.A.
        • et al.
        Comparison of astigmatic correction after femtosecond lenticule extraction and small-incision lenticule extraction for myopic astigmatism.
        PLoS One. 2015; 10e0123408
        • Zhang J.
        • Wang Y.
        • Wu W.
        • et al.
        Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up.
        BMC Ophthalmol. 2015; 15: 8
        • Qian Y.
        • Huang J.
        • Zhou X.
        • Wang Y.
        Comparison of femtosecond laser small-incision lenticule extraction and laser-assisted subepithelial keratectomy to correct myopic astigmatism.
        J Cataract Refract Surg. 2015; 41: 2476-2486
        • Kamiya K.
        • Shimizu K.
        • Igarashi A.
        • Kobashi H.
        Visual and refractive outcomes of small incision lenticule extraction for the correction of myopia: 1-year follow-up.
        BMJ Open. 2015; 5e008268
        • Qian Y.
        • Huang J.
        • Chu R.
        • et al.
        Influence of intraocular astigmatism on the correction of myopic astigmatism by femtosecond laser small-incision lenticule extraction.
        J Cataract Refract Surg. 2015; 41: 1057-1064
        • Hansen R.S.
        • Lyhne N.
        • Grauslund J.
        • Vestergaard A.H.
        Small-incision lenticule extraction (SMILE): outcomes of 722 eyes treated for myopia and myopic astigmatism.
        Graefes Arch Clin Exp Ophthalmol. 2016; 254: 399-405
        • Liu M.
        • Chen Y.
        • Wang D.
        • et al.
        Clinical outcomes after SMILE and femtosecond laser-assisted LASIK for myopia and myopic astigmatism: a prospective randomized comparative study.
        Cornea. 2016; 35: 210-216
        • Chan T.C.
        • Ng A.L.
        • Cheng G.P.
        • et al.
        Vector analysis of astigmatic correction after small-incision lenticule extraction and femtosecond-assisted LASIK for low to moderate myopic astigmatism.
        Br J Ophthalmol. 2016; 100: 553-559
        • Zhang J.
        • Wang Y.
        • Chen X.
        Comparison of moderate- to high-astigmatism corrections using wavefront-guided laser in situ keratomileusis and small-incision lenticule extraction.
        Cornea. 2016; 35: 523-530
        • Chan T.C.
        • Ng A.L.
        • Cheng G.P.
        • et al.
        Effect of location of opening incision on astigmatic correction after small-incision lenticule extraction.
        Sci Rep. 2016; 6: 35881
        • Pedersen I.B.
        • Ivarsen A.
        • Hjortdal J.
        Changes in astigmatism, densitometry, and aberrations after SMILE for low to high myopic astigmatism: a 12-month prospective study.
        J Refract Surg. 2017; 33: 11-17
        • Ganesh S.
        • Brar S.
        • Pawar A.
        Results of intraoperative manual cyclotorsion compensation for myopic astigmatism in patients undergoing small incision lenticule extraction (SMILE).
        J Refract Surg. 2017; 33: 506-512
        • Kanellopoulos A.J.
        Topography-guided LASIK versus small incision lenticule extraction (SMILE) for myopia and myopic astigmatism: a randomized, prospective, contralateral eye study.
        J Refract Surg. 2017; 33: 306-312
        • Khalifa M.A.
        • Ghoneim A.M.
        • Shaheen M.S.
        • Pinero D.P.
        Vector analysis of astigmatic changes after small-incision lenticule extraction and wavefront-guided laser in situ keratomileusis.
        J Cataract Refract Surg. 2017; 43: 819-824
        • Jun I.
        • Kang D.S.Y.
        • Reinstein D.Z.
        • et al.
        Clinical outcomes of SMILE with a triple centration technique and corneal wavefront-guided transepithelial PRK in high astigmatism.
        J Refract Surg. 2018; 34: 156-163
        • Pietila J.
        • Huhtala A.
        • Makinen P.
        • et al.
        Uncorrected visual acuity, postoperative astigmatism, and dry eye symptoms are major determinants of patient satisfaction: a comparative, real-life study of femtosecond laser in situ keratomileusis and small incision lenticule extraction for myopia.
        Clin Ophthalmol. 2018; 12: 1741-1755
        • Chan T.C.Y.
        • Wang Y.
        • Ng A.L.K.
        • et al.
        Vector analysis of high (≥3 diopters) astigmatism correction using small-incision lenticule extraction and laser in situ keratomileusis.
        J Cataract Refract Surg. 2018; 44: 802-810
        • Chan T.C.Y.
        • Wan K.H.
        • Kang D.S.Y.
        • et al.
        Effect of corneal curvature on optical zone decentration and its impact on astigmatism and higher-order aberrations in SMILE and LASIK.
        Graefes Arch Clin Exp Ophthalmol. 2019; 257: 233-240
        • Taneri S.
        • Kiessler S.
        • Rost A.
        • et al.
        Small-incision lenticule extraction for the correction of myopic astigmatism.
        J Cataract Refract Surg. 2019; 45: 62-71
        • Eydelman M.B.
        • Drum B.
        • Holladay J.
        • et al.
        Standardized analyses of correction of astigmatism by laser systems that reshape the cornea.
        J Refract Surg. 2006; 22: 81-95
        • Kunert K.S.
        • Russmann C.
        • Blum M.
        • Sluyterman V.L.G.
        Vector analysis of myopic astigmatism corrected by femtosecond refractive lenticule extraction.
        J Cataract Refract Surg. 2013; 39: 759-769
        • Messerschmidt-Roth A.
        • Sekundo W.
        • Lazaridis A.
        • Schulze S.
        [Three years follow-up study after refractive small incision lenticule extraction (SMILE) using 500 kHz femtosecond laser in “fast mode”].
        Klin Monbl Augenheilkd. 2017; 234: 102-108
        • Burazovitch J.
        • Ferguene H.
        • Naguszewski D.
        [Visual outcomes 5 years after small incision lenticule extraction (SMILE), surgery on spherocylindrical myopia eyes, from 616 eyes].
        J Fr Ophtalmol. 2018; 41: 433-440
        • Burazovitch J.
        • Naguzeswski D.
        • Beuste T.
        • Guillard M.
        [Visual outcomes four years after small incision lenticule extraction (SMILE) surgery on highly myopic eyes].
        J Fr Ophtalmol. 2017; 40: 561-570
        • Blum M.
        • Taubig K.
        • Gruhn C.
        • et al.
        Five-year results of small incision lenticule extraction (ReLEx SMILE).
        Br J Ophthalmol. 2016; 100: 1192-1195
        • Han T.
        • Zheng K.
        • Chen Y.
        • et al.
        Four-year observation of predictability and stability of small incision lenticule extraction.
        BMC Ophthalmol. 2016; 16: 149
        • Burazovitch J.
        • Naguzeswski D.
        • Beuste T.
        • Guillard M.
        Predictability of SMILE over four years in high myopes.
        J Fr Ophtalmol. 2017; 40: e201-e209
        • Guell J.L.
        • Verdaguer P.
        • Mateu-Figueras G.
        • et al.
        SMILE procedures with four different cap thicknesses for the correction of myopia and myopic astigmatism.
        J Refract Surg. 2015; 31: 580-585
        • Xia L.K.
        • Ma J.
        • Liu H.N.
        • et al.
        Three-year results of small incision lenticule extraction and wavefront-guided femtosecond laser-assisted laser in situ keratomileusis for correction of high myopia and myopic astigmatism.
        Int J Ophthalmol. 2018; 11: 470-477
        • Pedersen I.B.
        • Ivarsen A.
        • Hjortdal J.
        Three-year results of small incision lenticule extraction for high myopia: refractive outcomes and aberrations.
        J Refract Surg. 2015; 31: 719-724
        • Alio Del Barrio J.L.
        • Vargas V.
        • Al-Shymali O.
        • Alio J.L.
        Small incision lenticule extraction (SMILE) in the correction of myopic astigmatism: outcomes and limitations—an update.
        Eye Vis (Lond). 2017; 4: 26
        • Han T.
        • Xu Y.
        • Han X.
        • et al.
        Three-year outcomes of small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism.
        Br J Ophthalmol. 2019; 103: 565-568
        • Ivarsen A.
        • Asp S.
        • Hjortdal J.
        Safety and complications of more than 1500 small-incision lenticule extraction procedures.
        Ophthalmology. 2014; 121: 822-828
        • Wang Y.
        • Ma J.
        • Zhang J.
        • et al.
        Incidence and management of intraoperative complications during small-incision lenticule extraction in 3004 cases.
        J Cataract Refract Surg. 2017; 43: 796-802