Purpose: Laser in situ Keratomileusis (LASIK) is considered to be safe and effective for the treatment of moderate myopia. Nevertheless, the treatment can result in complications, associated with additional costs for treatment of the latter and an associated reduction of the primary treatment's overall cost efficiency.
Methods: To both identify clinically relevant LASIK-associated complications and to estimate their expectable incidence and treatment cost-profile, a quantitative meta-analysis of trial publications between 1995 - 2004 was implemented. Inclusion criteria were a minimum sample size of 25 eyes, a reported preoperative patient refraction between - 1 und - 14 dioptres and the documentation of an at least 6 months recall period. For each reported complication its "meta incidence" (point estimate and 95 % confidence interval) was estimated. Furthermore, for each complication a clinical pathway for its treatment was modelled assuming a worst case scenario; the treatment costs for this pathway were simulated. The resulting costs for the treatment of one complication were then averaged by the expectable incidence of the respective complication; the maximum "expectable" costs for the respective complication's treatment were then summed up to correct the overall LASIK direct costs.
Results: A total of 30 trial reports was included into the meta-analysis; in total, 21 clinically relevant complications were identified (31 % intraoperative complications, among which 19 % were microkeratome-associated, versus 69 % postoperative complications, among which 87 % were classified as long-term postoperative). The most frequent complication was "light sensations" with a meta incidence of 46 % (95 % confidence interval 42 - 50 %), the most cost intensive complications were those requiring clinical re-treatment (overall meta incidence 24 % and expectable cost increase of 449 euro per primary LASIK procedure). In summary the total direct costs of 2426 euro per eye for the initial LASIK procedure may be increased by a total of maximum 648.30 euro, according to a maximum "expectable" cost increase of 27 % per primary LASIK due to complications.
Conclusion: At least the worst case scenario introduced into this investigation demonstrated an economically relevant order for the expectable LASIK complications and the associated additional costs for complication treatment.