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

Br J Ophthalmol. 2016 Sep;100(9):1192-5. doi: 10.1136/bjophthalmol-2015-306822. Epub 2016 Jan 8.

Abstract

Background: To evaluate the 5-year results of Refractive Lenticule Extraction (ReLEx) as Small Incision Lenticule Extraction (SMILE) technique for treatment of myopia and myopic astigmatism.

Methods: In 2008/2009, the worldwide first 91 eyes were treated using a novel surgical technique (SMILE), where a refractive lenticule of intrastromal corneal tissue is removed though a small incision completely eliminating flap-cutting. 56 out of 91 eyes of the original treatment group volunteered for re-examination 5 years after surgery. Uncorrected distance visual acuity and corrected distance visual acuity after 5 years, objective and manifest refractions as well as evaluation of the interface and corneal surface by slit-lamp examination were documented. Late side effects like corneal scars, corneal ectasia, persistent dry eye symptoms or cataract were documented.

Results: 5 years postoperatively, no significant change to the 6-month data was found. Spherical equivalent was -0.375 D and therefore close to target refraction (emmetropia). 32 of the 56 eyes had gained 1-2 Snellen lines. There was no loss of 2 or more lines over the 5-year period. Regression in the long term was 0.48 D.

Conclusions: This first long-term study demonstrates SMILE to be an effective, stable and safe procedure for treatment of myopia and myopic astigmatism.

Clinical trial number: DE/CA93/KP/07/001. Post-results.

Keywords: Cornea; Treatment Lasers; Treatment Surgery.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Astigmatism / diagnosis
  • Astigmatism / physiopathology
  • Astigmatism / surgery*
  • Corneal Pachymetry
  • Corneal Stroma / pathology
  • Corneal Stroma / surgery*
  • Corneal Surgery, Laser / methods*
  • Corneal Topography
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Myopia / diagnosis
  • Myopia / physiopathology
  • Myopia / surgery*
  • Prospective Studies
  • Refraction, Ocular*
  • Time Factors
  • Treatment Outcome
  • Visual Acuity*
  • Young Adult