Vergleich der Langzeitergebnisse bei Small Incision Refractive Lenticule Extraction (ReLEx SMILE) und Femto-LASIK

Zusammenfassung

Zielsetzung Ziel dieser retrospektiven Analyse war es, im 5-Jahres-Verlauf die ReLEx-SMILE-Methode und die femtosekundenlaserassistierte LASIK (FsLASIK, Femto-LASIK) in Bezug auf Sicherheit, Effektivität, Stabilität und intraoperative Komplikationen umfassend zu vergleichen. Bisherige Vergleichsstudien beschränken sich auf maximal 3 Jahre, sodass unsere Ergebnisse erstmalig längerfristige Daten zeigen.

Material/Methoden Es wurden 404 Augen nach FsLASIK (Mel 80, Carl Zeiss Meditec) und 1192 Augen nach ReLEx SMILE (VisuMax, Carl Zeiss Meditec) verglichen. Erhoben wurden die verwendeten Patientendaten 6 Monate, 1 Jahr, 2 Jahre, 3 Jahre und 5 Jahre nach refraktivem Eingriff.

Ergebnisse Fünf Jahre postoperativ zeigten beide Methoden vergleichbare Ergebnisse bei allen untersuchten Parametern. Innerhalb dieser 5 Jahre zeigte die ReLEx-SMILE-Methode hinsichtlich Sicherheit nach 6 Monaten, 1 Jahr und 2 Jahren signifikant bessere Visuswerte (p < 0,05). Auch der Verlauf des Fernvisus war nach der ReLEx-SMILE-Methode 1 Jahr, 2 Jahre und 3 Jahre postoperativ signifikant besser. Die Vorhersagbarkeit beider Methoden war gleichwertig und auch die intraoperativen Komplikationen fielen bei beiden Methoden gleich niedrig aus.

Zusammenfassung Die retrospektive Analyse unserer 5-Jahres-Ergebnisse zeigt, dass die ReLEx-SMILE-Methode und die FsLASIK mindestens ebenbürtig in Bezug auf die Sicherheit und Effektivität sowie Stabilität der Refraktionswerte sind. Aufgrund der hohen Patientenzufriedenheit, des hohen postoperativen Patientenkomforts und der naturgemäßen Abwesenheit von Flap-Komplikationen ist die ReLEx SMILE bei uns und unseren Patienten die Methode der Wahl, wenn es um einen refraktivchirurgischen Eingriff an der Hornhaut zur Korrektur von Myopie und myopem Astigmatismus geht.

Abstract

Aim Our aim was to retrospectively compare ReLEx Smile to femtosecondlaser-assisted LASIK (FsLASIK, femto-LASIK) in terms of safety, efficacy, stability as well as intraoperative complications. Comparable studies only show the results over the course of 3 years, making our data the first to examine longer term results.

Materials/Methods To accomplish this, we compared 404 eyes after FsLASIK (Mel 80, Carl Zeiss Meditec) and 1192 eyes after ReLEx SMILE (VisuMax, Carl Zeiss Meditec). We collected patientsʼ data at 6 months, 1 year, 2 years and 5 years after refractive surgery.

Results Five years postoperatively, the 2 methods showed equally good results in all investigated parameters. Over the course of these 5 years, the ReLEx SMILE achieved significantly better results for safety (p < 0.05) after 6 months, 1 year and 2 years. The results for visual acuity were significantly better for ReLEx SMILE after 1, 2 and 3 years. The predictability of both methods was consistently good over the entire period of time and intraoperative complications were equally low.

Conclusion After retrospective analysis of the visual outcomes of our patients up to 5 years after surgery, the ReLEx SMILE method turned out to be at least as safe and efficient as the FsLASIK. The stability of the refractive outcome was equally good with the 2 methods. Due to the high level of satisfaction experienced by the patients, high patient comfort intra- and postoperatively, absence of dry eyes, and the absence of flap complications, ReLEx SMILE has replaced the FsLASIK in our daily practice and become our method of choice for corneal refractive surgery when it comes to the correction of myopia and myopic astigmatism.

Schlüsselwörter

refraktive Chirurgie - SMILE - LASIK - Femto-LASIK

Key words

refractive surgery - SMILE - LASIK - femto-LASIK

• Literatur

• 1 Knorz MC, Jendritza B, Liermann A. et al. [LASIK zur Myopiekorrektur: 2-Jahres-Ergebnisse]. Ophthalmologe 1998; 95: 494-498
• 2 OʼDoherty M, OʼKeeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006; 90: 20-23
• 3 Kato N, Toda I, Hori-Komai Y. et al. Five-year outcome of LASIK for myopia. Ophthalmology 2007; 115: 839-844.e2
• 4 Alió JL, Muftuoglu O, Ortiz D. et al. Ten-year follow-up of laser in situ keratomileusis for myopia of up to − 10 diopters. Am J Ophthalmol 2008; 145: 46-54
• 5 Kymionis GD, Tsiklis NS, Astyrakakis N. et al. Eleven-year follow-up of laser in situ keratomileusis. J Cataract Refract Surg 2007; 33: 191-196
• 6 Alió JL, Soria F, Abbouda A. et al. Laser in situ keratomileusis for − 6.00 to − 18.00 diopters of myopia and up to − 5.00 diopters of astigmatism: 15-year follow-up. J Cataract Refract Surg 2015; 41: 33-40
• 7 Dave R, OʼBrart DP, Wagh VK. et al. Sixteen-year follow-up of hyperopic laser in situ keratomileusis. J Cataract Refract Surg 2016; 42: 717-724
• 8 Shetty R, Francis M, Shroff R. et al. Corneal biomechanical changes and tissue remodeling after SMILE and LASIK. Invest Ophthalmol Vis Sci 2017; 58: 5703-5712
• 9 Chua D, Htoon HM, Lim L. et al. Eighteen-year prospective audit of LASIK outcomes for myopia in 53 731 eyes. Br J Ophthalmol 2018; DOI: 10.1136/bjophthalmol-2018-312587.
• 10 Kamiya K, Shimizu K, Igarashi A. et al. Visual and refractive outcomes of small incision lenticule extraction for the correction of myopia: 1-year follow-up. BMJ Open 2015; 26: e008268
• 11 Chansue E, Tanehsakdi M, Swasdibutra S, McAlinden C. Efficacy, predictability and safety of small incision lenticule extraction (SMILE). Eye Vis (Lond) 2015; 31: 14
• 12 Miao H, Tian M, Xu Y. et al. Visual outcomes and optical quality after femtosecond laser small incision lenticule extraction: an 18-month prospective study. J Refract Surg 2015; 31: 726-731
• 13 Pedersen IB, 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
• 14 Lentz SR, Tsiang M, Sadler JE. Regulation of thrombomodulin by tumor necrosis factor-alpha: comparison of transcriptional and posttranscriptional mechanisms. Blood 1991; 77: 542-550
• 15 Han T, Zheng K, Chen Y. et al. Four-year observation of predictability and stability of small incision lenticule extraction. BMC Ophthalmol 2016; 30: 149
• 16 Burazovitch J, Naguzeswski D, Beuste T. et al. Predictability of SMILE over four years in high myopes. J Fr Ophtalmol 2017; 40: e201-e209
• 17 Blum M, Täubig K, Gruhn C. et al. Five-year results of Small Incision Lenticule Extraction (ReLEx SMILE). Br J Ophthalmol 2016; 100: 1192-1195
• 18 Lee JK, Chuck RS, Park CY. Femtosecond laser refractive surgery: small-incision lenticule extraction vs. femtosecond laser-assisted LASIK. Curr Opin Ophthalmol 2015; 26: 260-264
• 19 Ganesh S, Gupta R. Comparison of visual and refractive outcomes following femtosecond laser-assisted LASIK with smile in patients with myopia or myopic astigmatism. J Refract Surg 2014; 30: 590-596
• 20 Ang M, Ho H, Fenwick E. et al. Vision-related quality of life and visual outcomes after small-incision lenticule extraction and laser in situ keratomileusis. J Cataract Refract Surg 2015; 41: 2136-2144
• 21 Ganesh S, Brar S, Pawar A. Matched population comparison of visual outcomes and patient satisfaction between 3 modalities for the correction of low to moderate myopic astigmatism. Clin Ophthalmol 2017; 11: 1253-1263 doi:10.2147/OPTH.S127101
• 22 Mohamed-Noriega K, Riau AK, Lwin NC. et al. Early corneal nerve damage and recovery following small incision lenticule extraction (SMILE) and laser in situ keratomileusis (LASIK). Invest Ophthalmol Vis Sci 2014; 55: 1823-1834
• 23 Mastropasqua L, Nubile M, Salgari N. et al. Refractive surgery preserving corneal neural architecture fewer nerves are severed in ReLEx SMILE than in LASIK. CRST Europe, Refractive Surgery, 2015.
• 24 Gyldenkerne A, Ivarsen A, Hjortdal JØ. Comparison of corneal shape changes and aberrations induced by FS-LASIK and SMILE for myopia. J Refract Surg 2015; 31: 223-229
• 25 Yan H, Gong L, Huang W. et al. Clinical outcomes of small incision lenticule extraction versus femtosecond laser-assisted LASIK for myopia: a meta-analysis. Int J Ophthalmol 2017; 10: 1436-1445
• 26 Xu L, Wang Y, Li J. et al. Comparison of forward light scatter changes between SMILE, femtosecond laser-assisted LASIK, epipolis LASIK: results of a 1-year prospective study. J Refract Surg 2015; 31: 752-758
• 27 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
• 28 Reinstein DZ, Archer TJ, Randleman JB. Mathematical model to compare the relative tensile strength of the cornea after PRK, LASIK, and small incision lenticule extraction. J Refract Surg 2013; 29: 454-460
• 29 Sinha Roy A, Dupps jr. WJ, Roberts CJ. Comparison of biomechanical effects of small-incision lenticule extraction and laser in situ keratomileusis: finite-element analysis. J Cataract Refract Surg 2018; 40: 971-980
• 30 Spiru B, Kling S, Hafezi F. et al. Biomechanical properties of human cornea tested by two-dimensional extensiometry ex vivo in fellow eyes: femtosecond laser-assisted LASIK versus SMILE. J Refract Surg 2018; 34: 419-423
• 31 Gao S, Li S, Liu L. et al. Early changes in ocular surface and tear inflammatory mediators after small-incision lenticule extraction and femtosecond laser-assisted laser in situ keratomileusis. PLoS One 2014; 9: e107370
• 32 Dong Z, Zhou X, Wu J. et al. Small incision lenticule extraction (SMILE) and femtosecond laser LASIK: comparison of corneal wound healing and inflammation. Br J Ophthalmol 2014; 98: 263-269
• 33 Breyer DR, Hagen P, Kaymak H. et al. [Impact of Different Percent Tissue Altered Values on Visual Outcome after Refractive Small Incision Lenticule Extraction (ReLEx SMILE)]. Klin Monatsbl Augenheilkd 2017; 234: 90-97 doi:10.1055/s-0042-117834
• 34 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