TABLE 1.
Complication | FDA Study* | Non-FDA Study† |
---|---|---|
Epithelial defect, % | 0.50 | 5.0–22.6 |
Lamellar keratitis, % | 0.99 | 0.2–3.2 |
Haze, % | 0.57 | 1.8–6.2 |
Flap folds, % | 1.00 | 0.2–1.1 |
Thin flap, % | 0.42 | 0.08–0.75 |
Free-cap, % | 3.40 | 0.08–1.00 |
Irregular flap, % | n/a | 0.09–0.2 |
Buttonholed flap, % | n/a | 0.13–0.56 |
Incomplete flap, % | n/a | 0.23–0.75 |
Dislodged flap, % | 0.22 | 1.1–2.0 |
Epithelial ingrowth, % | 0.14 | 0.33–9.1 |
Debris, % | 3.31 | 1.9–100 |
Infectious keratitis, % | 0.0 | 0–0.2 |
Post-LASIK ectasia, % | 0.0 | 0.2 |
Includes studies of wavefront-guided LASIK for myopia, LASIK for myopia, and LASIK for hyperopia.
Includes complications reported in studies of 1000 people or more and in reports focusing on specific complications. Data are presented as the proportion of patients affected. Modified with permission from Sakimoto et al.4
n/a, not available.