Good Cataract Surgery Outcomes Possible in Intraoperative Floppy Iris Syndrome Due to Tamsulosin

November 16, 2006

November 16, 2006 — In patients treated with tamsulosin ( Flomax) who undergo cataract surgery, the complication rate is low and visual outcome good when surgeons are forewarned regarding the history of tamsulosin use and employ appropriate operative strategies to manage the iris, according to a study presented here at the 2006 joint meeting of the American Academy of Ophthalmology and Asia Pacific Academy of Ophthalmology in Las Vegas, Nevada.

Tamsulosin is a commonly prescribed systemic alpha-1 adrenergic antagonist, a class of medications used to treat symptoms of benign prostatic hyperplasia (BPH). In a study of 1600 cataract patients completed in 2005, David F. Chang, MD, and John R. Campbell, MD, described a new small pupil syndrome, intraoperative floppy iris syndrome (IFIS), which is associated with this drug class.

IFIS has been linked to an increased rate of complications, including iris trauma, posterior capsule rupture, and vitreous loss. "With news of IFIS, doctors began raising questions about the safety of prescribing alpha-1 blockers and how to address the need for cataract surgery in patients already taking them," said presenter and lead investigator David F. Chang, MD, from Altos Eye Physicians in Los Altos, California. "We decided to investigate the risk of surgical complications when the surgeon anticipates IFIS and employs alternative methods of small pupil management."

During a 7-month period, 135 consecutive cataract patients receiving tamsulosin were enrolled across 10 study sites in the United States. Patients with a history of iridocyclitis, iris neovascularization, or prior iris surgery, and patients with traumatic cataracts, zonular dialysis, or cataracts associated with ocular disease were excluded.

Subjects underwent cataract surgery performed by one of 15 surgeons, who were asked to choose, at their discretion, among 4 pupil management techniques: iris retractors, pupil expansion ring, viscoadaptive ophthalmic viscosurgical device ( Healon 5), and preoperative topical atropine.

Data were collected for a total of 167 eyes. No IFIS was noted in 10% of eyes, and moderate (floppy iris, significant miosis, and a small tendency for iris prolapse) to severe (floppy iris, significant miosis, and a strong tendency for iris prolapse) IFIS was noted in 73% of eyes. Of the 32 eyes in patients who preoperatively ceased tamsulosin treatment, no change in IFIS severity was observed (Mann-Whitney test, z = 1.14; P = .26).

Complications included posterior capsule rupture and vitreous loss (0.6%; 95% confidence interval [CI], 0% - 1.8%) and clinical cystoid macular edema (0.6%; 95% confidence interval [CI], 0% - 1.8%). Best corrected visual acuity of at least 20/40 vision was achieved in 95% of eyes enrolled; of the 9 eyes that achieved lower visual acuity, cause was attributed to amblyopia (n = 1 eye), epiretinal membrane (n = 2 eyes), and age-related macular degeneration (n = 5 eyes).

"The 2 techniques most frequently used by the surgeons were Healon 5 and iris retractors, which are probably the most common techniques around the world," Dr. Chang told Medscape. "The study showed that the complication rates were very reasonable, and perhaps no higher than those in patients without a history of Flomax use. This is encouraging, because it suggests that experienced surgeons who know about Flomax use in advance can effectively achieve a good outcome."

Rosa Braga-Mele, MEd, MD, FRCS(C), associate professor at the University of Toronto and director of the cataract unit and surgical teaching at Mount Sinai Hospital in Toronto, Ontario, Canada, said the results of the study wereimportant because of apprehension on the part of surgeons to operate on patients using tamsulosin.

However, Dr. Braga-Mele pointed out, the relevance of alpha-1 blockers in eye surgery is not obvious to patients, and those under treatment for BPH may not report the medication use to an ophthalmologist. "This study shows that, as surgeons, we have an obligation to develop a thorough patient history, such that we know if patients have ever been on this medication," she said.

In addition, Dr. Braga-Mele said that surgeons should be prepared to employ IFIS management strategies due to the common use of alpha-1 blockers. "Because even previous use can have an effect, stopping the drug for surgical considerations is not useful," she explained. "Therefore, surgeons need to ensure they are familiar with at least 1 of the 4 mentioned surgical techniques."

Dr. Chang is a consultant for Advanced Medical Optics and Alcon.

2006 Joint Meeting of the AAO and APAO: Abstract PA078. Presented November 14, 2006.

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