Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin.

OBJECTIVE: To determine whether severe intraoperative floppy iris syndrome (IFIS) is more or equally likely with tamsulosin or alfuzosin.

DESIGN: Prospective, masked, multicenter, cross-sectional study.

PARTICIPANTS AND CONTROLS: Consecutive patients taking systemic tamsulosin or alfuzosin and scheduled for routine cataract surgery (case group) and patients with no history of systemic α1-antagonists scheduled for routine cataract surgery (control group).

METHODS: Phacoemulsification with intraocular lens implantation was performed and recorded on video. Intracameral phenylephrine or epinephrine, either by direct injection or placement in the irrigation bottle, was not permitted. Every surgical video subsequently was reviewed remotely by 2 masked investigators who diagnosed the presence or absence of IFIS and graded the severity of IFIS as follows: none, mild (billowing only), moderate (billowing and either iris prolapse or ≥2 mm of pupil constriction), or severe (billowing accompanied by iris prolapse and ≥2 mm of pupil constriction).

MAIN OUTCOME MEASURES: Rate and severity of IFIS and surgical complication rate.

RESULTS: A total of 226 eyes (70 in the tamsulosin group, 43 in the alfuzosin group, and 113 in the control group) were enrolled. Severe IFIS was noted in 34.3% (24/70) of the tamsulosin eyes and in 16.3% (7/43) of the alfuzosin eyes compared with 4.4% (5/113) of the control eyes. The differences between each of the 3 groups were statistically significant. In the absence of epinephrine in the irrigation bottle, 12.4% of control eyes had moderate to severe IFIS. There were no instances of posterior capsular rupture or significant surgical complications in either the case or control groups.

CONCLUSIONS: Moderate to severe IFIS can occur in low-risk eyes when epinephrine is omitted from the irrigation bottle. Although both tamsulosin and alfuzosin significantly increase the risk of IFIS compared with patients without prior α1-antagonist intake, severe IFIS statistically was more likely with tamsulosin than with alfuzosin (P = 0.036). Patients with symptomatic benign prostatic hyperplasia and cataracts requiring a uroselective α1-antagonist may consider trying alfuzosin first.