Risks and side-effects of eye laser surgery with SMILE®

No medical procedure is free of risks. Therefore, you need to be familiar with its limitations and possible risks before undergoing eye laser treatment. To minimize the risk of the procedure, we are giving you a guarantee for four things:

  • There is no flap in SMILE® and thus, there are no flap-related risks.
  • Dr. Breyer's experience from more than 60.000 operations gives you additional security.
  • We are performing more preliminary examinations than required by the KRC [Commission of Refractive Surgeons] to check your eligibility for the procedure.
  • We will never go to the limits of what is possible and will only recommend to you the method most secure for you - or will advise you not to do it.
Surfer with surf board walking out of the sea.

No worries about sports injuries: Since no flap is cut with SMILE pro, there is no greater risk during sports after laser eye surgery than before.

No flap, no flap-related complications

Both in femto-LASIK and LASIK, a flap incision of around 20 mm is required since the excimer laser cannot penetrate the topmost corneal layer. This incision destabilizes the eye's surface and has many additional side-effects which do not occur with SMILE®. "Dry eyes" and "sands of Sahara" occur significantly more rarely with the SMILE® method. The same applies to injuries to the epithelium and weakening of the cornea which can be attributed to the fact that the topmost corneal layer never gets attached as firmly again as it was before the femto-LASIK.

We never had a patient complaining of dry eyes after SMILE® treatment; at least theoretically, they can occur in the first days after the treatment. In dry eyes, a disorder of tear production occurs in the first few weeks as a consequence of the operation. By means of appropriate therapy, you can counteract this symptom. Sands of Sahara - which is actually called diffuse lamellar keratitis, DLK - is an inflammation below the flap after femto-LASIK or LASIK some patients experience. It can be treated with anti-inflammatory drops and has late consequences in rare cases only. In isolated cases, adhesions of the epithelium below the flap occur which can necessitate repeating the operation in an occasional case. As a consequence of these possible but rare complications, a reduction of visual acuity occurs in less than one percent of cases. However, this figure can be reduced even further by follow-up treatment. Therefore, please be sure to attend the aftercare appointments we indicated.

"The larger the surgeon's experience, the lower the risk."

Dr. Breyer, , 40,000 surgeries

Since the incision in the cornea is very small, these complications have not been described yet after SMILE®. Therefore, it is also suitable for patients with dry eyes.

Your specialist for eye laser surgery

Portraitfoto von Dr. Detlev Breyer

Dr. Detlev Breyer

Ophthalmologist, eye surgeon and lead surgeon
(img: focus_siegel.set.png alt: Focus Top Mediziner Auszeichnungen class: align-right-push) Dr. Breyer is a member of the teaching faculty of large specialist associations, not only in Germany but also in Europe and the US. Since 2011, he has been reporting on his experiences with ReLEx® SMILE on international congresses. In 2014, his presentation on the comparison of femto-LASIK and ReLEx® SMILE at the congress of the American Society of Cataract and Refractive Surgery (ASCRS) received the prize of best presentation of the meeting. Since 2013, he has been included in the list of Focus-Top-Mediziner [list of top doctors curated by the magazine Focus].

Why do microkeratome- and flap-related complications not occur with SMILE®?

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SMILE pro mit dem VISUMAX 800 (Zeiss)

First, no flap is cut in the gentle eye laser surgery procedure SMILE®, which means that no microkeratome is used. The SMILE® procedure also cannot be compared to femto-LASIK since the vision is corrected in a completely different way: Not with an excimer laser but with a femtosecond laser, or with the VISUMAX® 800® (Zeiss), to be precise. It can penetrate the topmost cornea to prepare a lenticule inside the cornea. A miniscule opening of 2 to 3 mm in the topmost corneal layer is sufficient to remove it. Due to this small incision, the risk of infection can be disregarded almost completely; it was reported in less than one case in ten thousand.

"Infection was reported in less than one case in ten thousand and can be disregarded almost completely in SMILE® due to the small incision."

Dr. Breyer

The surgeon's experience is key

There is a learning curve with every operation, and it is therefore not only obvious but also proven that an experienced surgeon makes less mistakes. The SMILE® eye laser surgery procedure firstly requires a lot of routine in handling the femtosecond laser and secondly requires a lot of practice in preparing the lenticule. Dr. Breyer is one of the first users of this eye laser surgery procedure globally and has performed more than 5.000 SMILE® operations. In addition, he is a high-volume surgeon specialized in minimally invasive procedures who has performed more than 60.000 procedures. He knows how to also handle difficult situations correctly - this gives you additional security.

Dr. Breyer is talking to a patient

Dr. Breyer is talking to a patient

Excessive or insufficient correction can be improved upon in a second operation in most cases

In eye laser treatment, there is always a risk of excessive or insufficient correction. While our patients have gained a visual acuity of 100% without additional correction by glasses or contact lenses after a SMILE® operation so far, a slight deviation from the planned target refraction cannot be ruled out on principle. In this case, you would still have to wear glasses or contact lenses even after the treatment, even if they had much lower diopter values. In particular, this applies to activities in which you have to rely on very good vision, for example while driving.

The results for patients with astigmatism (abnormal corneal curvature) or very high values to be corrected are frequently not as good as those for patients with only very slight ametropia - in these cases, we are therefore recommending the placement of contact lenses (ICL) or lenses (IOL) into the eye. In most cases, the excessive or insufficient correction can be improved upon in a second operation. In this case, we would recommend PRK which also forgoes the flap. Another advantage is the stability of the result. The visual acuity you can achieve only a short time after the operation can worsen again over time. Glares and halos can also occur in twilight and at night, in particular with higher-degree ametropia.

What’s precious to you belongs in good hands

If you are interested in having the best vision without glasses, please feel free to make an appointment with Dr. Breyer for a non-binding individual consultation or preliminary examination. You can make an appointment by phone, e-mail, WhatsApp or our appointment app. We are also happy to call you back. We are looking forward to your message.

Further literature

Postoperative Corneal Complications in Small Incision Lenticule Extraction: Long-Term Study

Yan Wang, MD, PhD; Jiaonan Ma, MD; Lin Zhang, MD, PhD; Haohan Zou, MD; Jinxiao Li, MD; Yue Zhang, MD; Vishal Jhanji, MD; Journal of Refractive Surgery. 2019;35(3):146-152 doi.org/10.3928/1081597X-20190118-02.

Five-year results of Small Incision Lenticule Extraction (ReLEx SMILE)

Blum M, Täubig K, Gruhn C, Sekundo W, Kunert KS. Br J Ophthalmol. 2016 Jan 8. pii: bjophthalmol-2015-306822. doi: 10.1136/bjophthalmol-2015-306822. [Epub ahead of print] PubMed PMID: 26746577.

Clinical Outcomes of Small Incision Lenticule Extraction with Accelerated Cross-Linking (ReLEx SMILE Xtra) in Patients with Thin Corneas and Borderline Topography

Ganesh S, Brar S. J Ophthalmol. 2015;2015:263412. doi: 10.1155/2015/263412. Epub 2015 Jun 28. PMID: 26221538; PMC ID: PMC4499409

Short-term outcomes of Small Incision Lenticule Extraction (SMILE) for low, medium and high myopia.

Fernández J, MD; Valero A, MD; Martínez J, OD; Piñero DP, PhD; Rodríguez-Vallejo M, OD, Journal of Refractive Surgery 2015, 429, 1.

One-year refractive results, contrast sensitivity, high-order aberrations and complications after myopic small-incision lenticule extraction (ReLEx SMILE)

Sekundo W, Gertnere J, Bertelmann T, Solomatin I. Graefes Arch Clin Exp Ophthalmol. 2014 May;252(5):837-43. doi: 10.1007/s00417-014-2608-4. Epub 2014 Mar 20. PMID: 24647595

Early corneal nerve damage and recovery following small incision lenticule extraction (SMILE) and laser in situ keratomileusis (LASIK)

Mohamed-Noriega K, Riau AK, Lwin NC, Chaurasia SS, Tan DT, Mehta JS. Invest Ophthalmol Vis Sci. 2014 Mar 25;55(3):1823-34. doi: 10.1167/iovs.13-13324. PubMed PMID: 24569584

SMILE versus Femto-LASIK. Vergleich von optischer Abbildungsqualität sowie Effektivität und Sicherheit — PDF, 183.31 kB >

Breyer D., Der Augenspiegel, 06, 2013, 32-35

Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction

Original Research Article, Anders Vestergaard, Anders R. Ivarsen, Sven Asp, Jesper Ø. Hjortdal, J Cataract Refract Surg. 2012 Nov;38(11):2003-10. doi: 10.1016/j.jcrs.2012.07.021. Epub 2012 Sep 14. PMID: 22981612

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

Ang M, Tan D, Mehta JS. Source: Singapore National Eye Centre, Singapore, Trials. 2012 May 31;13:75. doi: 10.1186/1745-6215-13-75. PMID: 22647480 [PubMed - indexed for MEDLINE]

Early clinical outcomes, including efficacy and endothelial cell loss, of refractive lenticule extraction using a 500 kHz femtosecond laser to correct myopia

Kazutaka Kamiya, Akihito Igarashi, Rie Ishii, Nobuyuki Sato, Hiroyuki Nishimoto, Kimiya Shimizu, Journal of Cataract & Refractive Surgery, Volume 38, Issue 11, November 2012, Pages 1996-2002

Results of small incision lenticule extraction: All-in-one femtosecond laser refractive surgery

Rupal Shah, MS, Samir Shah, M.Tech, Sayantan Sengupta, DO, From New Vision Laser Centers, Vadodara, Gujarat, India, Journal of Cataract and Refractive Surgery, Jan 2011, Vol 37, Iss 1, Pages 127 – 137

Comparison of Visual and Refractive Outcomes Following Femtosecond Laser-Assisted LASIK With SMILE in Patients With Myopia or Myopic Astigmatism

Sri Ganesh, MS, DNB; Rishika Gupta, MS, [J Refract Surg. 2014;30(9):590-596.], doi:10.3928/1081597X-20140814-02, PubMed PMID: 25250415.

Five-year results of refractive lenticule extraction

Marcus Blum, Andrea Flach, Kathleen S. Kunert, MD, Walter Sekundo, MD, J Cataract Refract Surg 2014; 40:1425-1429 2014 ASCRS and ESCRS

Outcomes of small incision lenticule extraction (SMILE) in low myopia.

Reinstein DZ, Carp GI, Archer TJ, Gobbe M. J Refract Surg. 2014 Dec;30(12):812-8. doi: 10.3928/1081597X-20141113-07. Erratum in: J Refract Surg. 2015 Jan;31(1):60. PubMed PMID: 25437479.

Refractive lenticule extraction: Transition and comparison of 3 surgical techniques

Marcus Ang, FAMS, FRCSEd, Jodhbir S. Mehta, FRCOph, Cordelia Chan, FRCSEd Hls M. Htoon, PhD, Jane C. W. Koh, Adv. Dip. Statistics, Donald T. Tan, FRCOph, J Cataract Refract Surg 2014: 40:1415-1424 2014 ASCRS und ESCRS

Dry Eye Disease after Refractive Surgery – Comparative Outcomes of Small Incision Lenticule Extraction versus LASIK

Alexandre Denoyer, MD, PhD, Elise Landman, MD, Liem Trinh, MD, Jean-François Faure, MD, François Auclin, MD, Christophe Baudouin, MD, PhD, Ophthalmology 2015;122:669-676 2015 by the American Academy of Ophthalmology. doi: 10.1016/j.ophtha.2014.10.004. Epub 2014 Nov 22. PubMed PMID: 25458707

SMILE Procedures With Four Different Cap Thicknesses for the Correction of Myopia and Myopic Astigmatism

Jose L. Güell, MD, PhD; Paula Verdaguer, MD; Gloria Mateu-Figueras, PhD; Daniel Elies, MD; Oscar Gris, MD, PhD; Mostafa A. El Husseiny, MD; Felicidad Manero, MD; Mercè Morral, MD, PhD, [J Refract Surg. 2015;31(9):580-585.], doi:10.3928/1081597X-20150820-02

Influence of femtosecond lenticule extraction and small incision lenticule extraction on corneal nerve density and ocular surface: a 1-year prospective confocal, microscopic study

Ishii R, Shimizu K, Igarashi A, Kobashi H, Kamiya K. J, Refract Surg. 2015 Jan;31(1):10-5. doi: 10.3928/1081597X-20141218-01. PubMed PMID: 25599538.

Energy Setting and Visual Outcomes in SMILE: A Retrospective Cohort Study

Liuyang Li, MD; Julie M. Schallhorn, MD; Jiaonan Ma, MD; Tong Cui, MD; Yan Wang, MD, PhD. in: Journal of Refractive Surgery. 2018;34(1):11-16 https://doi.org/10.3928/1081597X-20171115-01

First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia: six-month results

Sekundo W, Kunert K, Russmann C, Gille A, Bissmann W, Stobrawa G, Sticker M, Bischoff M, Blum M. J Cataract Refract Surg. 2008;34:1513–1520. PMID: 18721712 DOI: https://doi.org/10.1016/j.jcrs.2008.05.033.