Meta-analysis of the FDA Reports on Patient-Reported Outcomes Using the Three Latest Platforms for LASIK

J Refract Surg. 2017 Jun 1;33(6):362-368. doi: 10.3928/1081597X-20161221-02.


Purpose: To analyze the impact of the three latest U.S. Food and Drug Administration (FDA)-approved lasers on patient-reported outcomes after LASIK.

Methods: In this meta-analysis of patient-reported FDA data, an aggregated total of 718 eyes undergoing LASIK using VISX iDesign (Abbott Medical Optics Manufacturing, Milpitas, CA), Alcon Contoura (Alcon Research, Ltd., Fort Worth, TX), and Nidek CATz (Nidek Co. Ltd., Gamagori, Japan) lasers were evaluated for overall changes in visual symptoms postoperatively. Statistical significance was calculated when appropriate to assess changes. A P value of less than .05 was considered statistically significant.

Results: At 12 months following LASIK, there was a decrease in the postoperative difficulty driving at night (29%) with respect to preoperative values. There was a significant postoperative reduction in prior moderate to severe symptoms for light sensitivity (9%), difficulty driving at night (22%), reading difficulty (8%), double vision (2%), glare (12%), and halos (6%) at 12 months following LASIK.

Conclusions: Analysis of the FDA data shows that modern lasers have significantly improved patient-reported visual outcomes after LASIK. [J Refract Surg. 2017;33(6):362-368.].

Publication types

  • Comparative Study
  • Meta-Analysis

MeSH terms

  • Automobile Driving
  • Corneal Stroma / surgery
  • Corneal Topography
  • Glare*
  • Humans
  • Keratomileusis, Laser In Situ / methods*
  • Lasers, Excimer / therapeutic use*
  • Myopia / physiopathology
  • Myopia / surgery*
  • Patient Reported Outcome Measures*
  • Refraction, Ocular / physiology*
  • United States
  • United States Food and Drug Administration
  • Visual Acuity / physiology*