A Report by the American Academy of Ophthalmology Ophthalmic Technology Assessment Committee Refractive Management/Intervention Panel: Ayad A. Farjo, MD1; Alan Sugar, MD, MS2; Steven C. Schallhorn, MD3; Parag A. Majmudar, MD4; David J. Tanzer, MD5; William B. Trattler, MD6; John B. Cason, MD7; Kendall E. Donaldson, MD, MS8; George D. Kymionis, MD, PhD9
Ophthalmology, March 2013, Vol 120, e5-e20 © 2013 by the American Academy of Ophthalmology. Click here for free access to the OTA.
Objective: To review the published literature to assess the safety, efficacy, and predictability of femtosecond lasers for the creation of corneal flaps for LASIK; to assess the reported outcomes of LASIK when femtosecond lasers are used to create corneal flaps; and to compare the differences in outcomes between femtosecond lasers and mechanical microkeratomes.
Methods: Literature searches of the PubMed and Cochrane Library databases were last conducted on October 12, 2011, without language or date limitations. The searches retrieved a total of 636 references. Of these, panel members selected 58 papers that they considered to be of high or medium clinical relevance and the panel methodologist rated each article according to the strength of evidence. Four studies were rated as level I evidence, 14 studies were rated as level II evidence, and the remaining studies were rated as level III evidence.
Results: The majority of published studies evaluated a single laser platform. Flap reproducibility varied by device and the generation of the device. Standard deviations in flap thicknesses ranged from 4 to 18.4 µm. Visual acuities and complications reported with LASIK flaps created using femtosecond lasers are within Food and Drug Administration safety and efficacy limits. Of all complications, diffuse lamellar keratitis is the most common after surgery but is generally mild and self-limited. Corneal sensation was reported to normalize by 1 year after surgery. Unique complications of femtosecond lasers included transient light-sensitivity syndrome, rainbow glare, opaque bubble layer, epithelial breakthrough of gas bubbles, and gas bubbles within the anterior chamber.
Conclusions: Available evidence (level I and II) indicates that femtosecond lasers are efficacious devices for creating LASIK flaps, with accompanying good visual results. Overall, femtosecond lasers were found to be as good as or better than mechanical microkeratomes for creating LASIK flaps. There are unique complications that can occur with femtosecond lasers and long-term follow-up is needed to evaluate the technology fully.
1 Brighton Vision Center, Brighton, Michigan
2 Ophthalmology and Visual Ciences, W.K. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan
3 University of California, San Francisco, California; Global Medical Director Optical Express; Gordon-Weiss-Schanzlin Vision Institute, San Diego, California
4 Chicago Cornea Consultants Ltd., Chicago, Illinois
5 Gordon-Weiss-Schanzlin Vision Institute, San Diego, California
6 Center for Excellence in Eye Care, Miami, Florida
7 Ophthalmology Clinic, Naval Medical Center, San Diego, California
8 Bascom Palmer Eye Institute of Plantation, Plantation, Florida
9 Institute of Vision Optics (IVO), Faculty of Medicine, University of Crete, Heraklion, Crete, Greece