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Two Studies Link Flomax to IFIS

David F. Chang, M.D., and John R. Campbell, M.D., last year identified a new small-pupil syndrome occurring during a small percentage of cataract surgeries, which they named Intraoperative Floppy Iris Syndrome (IFIS). Through sleuthing worthy of Sherlock Holmes, the two surgeons were able to link IFIS to the use of Flomax (tamsulosin, Boehringer-Ingelheim, Ingelheim, Germany), the most commonly prescribed alpha-adrenergic blocker for the treatment of benign prostatic hypertrophy, or BPH.

	IFIS is characterized by iris billowing, prolapse to phaco and side port incisions, and progressive miosis during phaco. IMAGE: COURTESY OF DAVID CHANG, M.D.

IFIS during cataract surgery is characterized by iris billowing in response to normal irrigating fluid currents; a strong tendency toward iris prolapse, and progressive miosis during the phaco and cortical irrigation/aspiration steps.

To substantiate their initial findings, Drs. Chang and Campbell undertook two companion studies:

► retrospective study reviewed the cases of 511 consecutive cataract patients (706 eyes) over a 12-month period to assess the percentage of patients who were on Flomax or other alpha-adrenergic blockers, and to determine the percentage of patients who manifested IFIS.

► separate prospective study involved 741 consecutive patients (900 eyes) and was used to determine the incidence of IFIS and the percentage of these patients who were taking Flomax and other alpha-adrenergic blockers.

Following are the primary results of the retrospective study:

► patients on alpha-adrenergic blockers for BPH: 27 (all men)

► patients on Flomax: 16

► patients on other alpha-adrenergic blockers: 11

► percentage of all patients on alpha-adrenergic blockers: 3%

► patients manifesting IFIS: 10

► Flomax patients manifesting IFIS: 10

► all other patients manifesting IFIS: 0

► percentage of all patients manifesting IFIS: 2%

Following are the primary results of the prospective study:

► patients manifesting IFIS: 16 (these patients were all men)

► percentage of patients manifesting IFIS: 2.2%

► IFIS patients on Flomax at time of surgery: 14*

► percentage of 725 non-IFIS patients taking Flomax: 0%

*One other IFIS patient had stopped taking Flomax more than a year prior to his surgery.

Conclusions:

From these studies, Drs. Chang and Campbell conclude that IFIS occurred in approximately 2% of the cataract surgery population under review, and that IFIS appears to be directly caused by use of Flomax. They further note that progressive intraoperative miosis, such as that occurring with IFIS, significantly increases the risk of cataract surgical complications.

The authors advise that all cataract patients should be questioned preoperatively about concurrent or prior use of Flomax. They conclude that pupil-stretching techniques are ineffective in IFIS cases, and that the use of iris hooks or expansion rings before initiating the capsulorhexis may be preferable. They also mention Healon5 and bimanual microincisional phaco as potentially helpful techniques.

About this data: For their retrospective study, Drs. Chang and Campbell reviewed consecutive cataract surgeries on 706 eyes over a
12-month period in a two-surgeon practice to asses the percentage of patients on alpha-adrenergic blockers. For their prospective study, the doctors reviewed cataract surgeries on 900 consecutive eyes performed in another practice to determine the incidence of IFIS and the percentage of IFIS cases who were taking alpha-adrenergic blockers. The paper by Drs. Chang and Campbell detailing the complete results and conclusions of the two IFIS studies can be found in the April 2005 issue of the Journal of Cataract and Refractive Surgery.