Evolution in the Risk of Cataract Surgical Complications among Patients Exposed to Tamsulosin: A Population-Based Study.

PURPOSE: Tamsulosin is associated with intraoperative floppy iris syndrome (IFIS), an important risk factor for complications during cataract surgery. Significant efforts have been made to increase awareness of the risks associated with tamsulosin, and educational initiatives have fostered the uptake of technical adjustments to decrease adverse event rates among tamsulosin-exposed patients. However, the effectiveness of these efforts at the population level has not been studied.

DESIGN

Population-based study to evaluate cataract surgical adverse event rates over time among patients exposed to tamsulosin and those not exposed to this drug.

PARTICIPANTS

All male patients 66 years of age and older undergoing cataract surgery in Ontario, Canada, between January 1, 2003, and December 31, 2013, were included in the study.

METHODS

Linked healthcare databases were used to study the evolution in the risk of cataract surgical adverse events over time among tamsulosin-exposed and non-tamsulosin-exposed patients adjusting for patient-, surgeon-, and institution-level covariates. The study timeframe incorporated periods before and after the first reports of tamsulosin-associated IFIS.

MAIN OUTCOME MEASURES: Four important cataract surgical adverse events were evaluated: posterior capsule rupture, dropped lens fragments, retinal detachment, and suspected endophthalmitis.

RESULTS

Among patients exposed to tamsulosin, the risk of surgical adverse events decreased over time (odds ratio, 0.95 per year; 95% confidence interval, 0.91-0.99 per year). This trend was observed across patient age strata. Among patients not recently exposed to tamsulosin, the risk of surgical adverse events also decreased over time (odds ratio, 0.96 per year; 95% confidence interval, 0.95-0.98 per year).

CONCLUSIONS

The risk of cataract surgical complications among both tamsulosin-exposed and non-tamsulosin-exposed patients declined between 2003 and 2013. Tamsulosin remains an important risk factor for cataract surgical adverse events, and ongoing efforts will be needed to develop and disseminate surgical approaches that mitigate the risks posed by tamsulosin.