Clinical benefit, complication patterns and cost effectiveness of laser in situ keratomileusis (LASIK) in moderate myopia: results of independent meta analyses on clinical outcome and postoperative complication profiles.

PURPOSE Laser in situ keratomileusis (LASIK) means a patient investment of 2426 Euro per eye, which usually cannot be funded by European health care insurers. In the context of recent resource allocation discussions, however, the cost effectiveness of LASIK could become an important indication of allocation decisions. Therefore an evidence based estimation of its incremental cost effectiveness was intended. METHODS Three independent meta analyses were implemented to estimate the refractive gain (dpt) due to conventional LASIK procedures as well as the predictability of the latter (%) (fraction of eyes achieving a postoperative refraction with maximum deviation of +/- 0.5 dpt from the target refraction). Study reports of 1995 - 2004 (English or German language) were screened for appropriate key words. Meta effects in refractive gain and predictability were estimated by means and standard deviations of reported effect measures. Cost data were estimated by German DRG rates and individual clinical pathway calculations; cost effectiveness was then computed in terms of the incremental cost effectiveness ratio (ICER) for both clinical benefit endpoints. A sensitivity analysis comprised cost variations of +/- 10 % and utility variations alongside the meta effects' 95% confidence intervals. RESULTS Total direct costs from the patients' perspective were estimated at 2426 Euro per eye, associated with a refractive meta benefit of 5.93 dpt (95% meta confidence interval 5.32 - 6.54 dpt) and a meta predictability of 67% (43% - 91%). In terms of incremental costs, the unilateral LASIK implied a patient investion of 409 Euro (sensitivity range 351 - 473 Euro) per gained refractive unit or 36 Euro (27 - 56 Euro) per gained percentage point in predictability. When LASIK associated complication patterns were considered, the total direct costs amounted up to 3075 Euro, resulting in incremental costs of 519 Euro / dpt (sensitivity range 445 - 600 Euro / dpt) or 46 Euro / % (34 - 72 Euro / %). Most frequently reported LASIK complications were "central islands / over- / undercorrection / regression" (meta incidence estimate 24%) and "haze" (15%), which were identified by means of an independent meta analysis. CONCLUSION Bearing incremental costs of 519 Euro per gained refractive unit in mind, the conventional LASIK procedures showed an encouraging cost effectiveness range; the latter estimate may serve as a rationale for future allocation discussions in ophthalmology.