Medical malpractice predictors and risk factors for ophthalmologists performing LASIK and photorefractive keratectomy surgery.

PURPOSE: To identify physician predictors in LASIK and photorefractive keratectomy (PRK) surgery that correlate with a higher risk for malpractice liability claims and lawsuits. DESIGN: Retrospective, longitudinal, cohort study. PARTICIPANTS AND METHODS: A comparison of physician demographic and practice pattern data of 100 consecutive Ophthalmic Mutual Insurance Company (OMIC) LASIK and PRK claims and lawsuits with demographic and practice pattern data for all active refractive surgeons insured by OMIC between 1996 to 2002 was made. Background information and data were obtained from OMIC underwriting applications, a physician practice pattern survey, and claims file records. Using an outcome of whether or not a physician had a history of a claim or lawsuit, logistic regression analyses were used separately for each predictor as well as controlling for refractive surgery volume. MAIN OUTCOME MEASURE: Malpractice claim or lawsuit for performance of PRK or LASIK surgery. RESULTS: Logistic regression analysis demonstrated that the most important predictor of filing a claim was surgical volume, with those performing more surgery having a greater risk of incurring a claim (odds ratio [OR] = 31.4 for >1000 surgeries/year versus 0-20 surgeries/year, 95% confidence interval [CI] = 7.9-125, P = 0.0001). Having one or more prior claim was the only other predictor examined that remained statistically significant after controlling for patient volume (OR = 6.4, 95% CI = 2.5-16.4, P = 0.0001). Physician gender, advertising use, preoperative time spent with patient, and comanagement seemed to be strong predictors in multivariate analyses when surgical volume was greater than 100 cases per year. CONCLUSION: The chances for incurring a malpractice claim or lawsuit for PRK or LASIK correlate significantly with higher surgical volume and a history of a claim or lawsuit. Additional risk factors that increase in importance with higher surgical volume include physician gender, advertising use, preoperative time spent with the patient, and comanagement with optometrists. These findings may be used in the future to help improve the quality of care for patients undergoing refractive surgery and to provide data for underwriting criteria and risk management protocols to manage proactively and perhaps reduce the risk for claims and lawsuits against refractive surgeons.

Keratectasia after laser in situ keratomileusis (LASIK): evaluation of the calculated residual stromal bed thickness.

PURPOSE: To report corneal histopathology associated with keratectasia after laser in situ keratomileusis (LASIK) and to evaluate the thickness of the calculated residual stromal bed in two cases and those in the literature. DESIGN: Interventional case reports. METHODS: Three eyes of two patients developed keratectasia after LASIK. Corneal specimens after penetrating keratoplasty in one eye of each patient were studied histopathologically, and the residual stromal bed was directly measured. For comparison, residual stromal bed thicknesses were calculated from published cases of keratectasia. RESULTS: Two eyes of a 26-year-old woman and one eye of a 22-year-old woman developed keratectasia after LASIK. Calculated residual stromal bed thicknesses were 210, 213, and 261 microm. Histologic sections revealed focal scarring in the flap plane. The cornea specimens measured 75 and 118 microm thinner than calculated values immediately after LASIK. Transmission electron microscopy of one case revealed an average lamellar thickness of 0.94 microm. In 28 (49%) of 57 previous cases of keratectasia, the calculated residual stromal bed thicknesses were greater than 250 microm. CONCLUSIONS: Both the flap and the stromal bed of the cornea may thin after LASIK. A residual stromal bed thickness of 250 microm does not preclude the development of keratectasia after LASIK.