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Physician Advisory: Flomax Appears to be the Cause of a Newly Described Small Pupil Syndrome.
Intraoperative Floppy Iris Syndrome (IFIS), a new small pupil disorder, appears to be associated with the use of tamsulosin (Flomax; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT), according to an ASCRS member alert. In response to preliminary reporting of two companion studies that identified the new syndrome and its association with this drug, the ASCRS issued a physician advisory on Flomax, a common treatment for symptomatic benign prostatic hypertrophy (BPH). The results of the studies have been submitted for publication in the Journal of Cataract & Refractive Surgery and will also be reported at the ASCRS Symposium in April.
David F. Chang, MD, of Los Altos, CA, and John R. Campbell, MD, of San Rafael, CA, performed the studies (one prospective, the other retrospective), which involved more than 1,600 patients combined. The studies sought to characterize the operative features, incidence, cause, and best course of management of IFIS.
"With the studies' results, we found convincing evidence that the cause of IFIS is Flomax, and that the incidence of this syndrome in a cataract surgical population is 2.3%," Dr. Chang told CRSToday.
Flomax is unique among the class of alpha1 antagonists in that it is highly selective for the alpha1A receptor subtype that predominates in the prostate. In terms of other systemic effects, such as postural hypotension, Flomax is more uroselective when compared to other nonsubtype specific alpha1 blockers used for symptoms of BPH. Drs. Chang and Campbell's review of the pharmacologic literature suggests that the same alpha1A receptor subtype that predominates in the prostate is also the primary subtype that mediates contraction of the iris dilator smooth muscle. The authors hypothesize that as patients take Flomax over time there is atrophy of their iris dilator smooth muscle. "It is the loss of this normal tone that we believe causes the iris to billow and prolapse in response to normal intraocular fluid currents," Dr. Chang told CRSToday. "This finding also explains why IFIS still occurs in some patients who have been off the drug for more than 1 year." Although in some cases, stopping Flomax use preoperatively for 1 to 2 weeks results in less miosis and billowing, the benefit is variable, and it unfortunately does not prevent IFIS in many eyes.
The authors state that IFIS is characterized by subnormal preoperative pupil dilation and repeated incisional prolapse of a billowing, floppy iris, which results in progressive intraoperative miosis. According to Dr. Chang, in IFIS, mechanical pupil stretching and partial thickness sphincterotomies do not effectively expand or maintain the pupil diameter. Iris retractors or pupil expansion rings are the most effective way to manage these cases, Dr. Chang said. He points out that these devices are less commonly used for small pupil management because of the increased surgical time and expense. In addition, these devices are more difficult to safely insert once the capsulorhexis has been completed. "The ability to anticipate IFIS in advance of surgery can allow surgeons to alter their usual method of pupil expansion before the capsulorhexis step," he said.
"As one might predict, Dr. Campbell and I found that the iris prolapse and the unpredictable and unexpected miosis associated with IFIS increases the risk of cataract surgery complications," Dr. Chang said. "These complications include posterior capsule rupture, and permanent iris transillumination defects." However, what is not clear is what the complication rate will be going forward, now that surgeons can anticipate IFIS and be prepared to use iris retractors. "The belief that such knowledge, understanding, and recognition of IFIS can make a difference in surgical outcomes is the reason that we wrote the preliminary article, and that ASCRS issued this special member alert," said Dr. Chang.
Restrictions Placed on New Jersey Nurse Anesthetists
The Superior Court of New Jersey Appellate Division recently ruled in favor of more stringent office anesthesia regulations to be imposed on nurse anesthetists. The New Jersey State Board of Medical Examiners proposed the standards of supervision for certified registered nurse anesthetists (CRNAs), which will go into effect on February 1. However, the New Jersey Association of Nurse Anesthetists is taking action to have the recently passed legislation overturned by the Supreme Court of New Jersey.
According to a press release from the American Medical Association, the regulations require two physicians to be present during surgery, one to perform the procedure and the other to either supervise the CRNA or administer the anesthesia. The legislation also allows physicians who do not possess hospital-anesthesia rights to apply for alternative privileging. Only offices with a single surgical suite will be affected because the state's department of health regulates those with two or more surgical suites.
Ray Cantor, Director of Governmental Affairs for the Medical Society of New Jersey is very pleased with the decision of the Superior Court, "This is one of those scope-of-practice victories that are rare to achieve, and it's very good for patient safety." Although tighter regulations have also been placed on physicians with this ruling, in terms of anesthesia certification, Mr. Cantor maintains that physicians are reacting by taking the appropriate measures in order to qualify to supervise the CRNA.
Mitch Tobin, the director of state government affairs for the American Association of Nurse Anesthetists, is concerned about a loss of jobs among New Jersey's 400 CRNAs and does not believe patient safety is compromised by permitting CRNAs to administer anesthesia during office surgeries.
The scope-of-practice issue regarding physician supervision of CRNAs has been contested in many states. Currently, 12 states authorize CRNAs to care for Medicare patients in hospitals without the supervision of a physician.
Preliminary Results Prove Promising in European Tetraflex Study
Lenstec, Inc. (St. Petersburg, FL), the manufacturer of the Tetraflex, conducted European clinical trials on the IOL, which provides versatile near, far, and intermediate vision. Deepak Chitkara, MD, FRCOphth, of Liverpool England, consultant for Lenstec, presented preliminary results at the ESCRS/Paris 2004 meeting. A total of 42 eyes of 28 patients were examined. Results of a 3-month follow-up on 20 eyes and a 6-month follow-up on 11 eyes revealed improvements in both uncorrected near vision bilaterally (from J14.9 preoperatively to J2.66 at 6 months) and distance corrected near vision (reported as J4.54 at 3 months and J4.62 at 6 months).
Monocularly, 57% of patients attained J3 or better, while 86% attained J5 or better, uncorrected. Results of binocular vision were even more optimal, with 89% of the patients reading J3 or better unaided at 3 months, and 100% reading J5 or better unaided at 6 months. Average accommodation achieved at 3 months was 3.42D and 3.75D at 6 month binocularly. Although the trials are still in early stages, no patients have experienced any adverse effects and the Tetraflex has already received the CE Mark in Europe.
In related news, Jim Simms, formerly of Thinoptx, Chiron Vision, and CILCO, has been appointed VP of Refractive Products for Lenstec. Mr. Simms brings solid expertise in the development and approval of IDEs, PMAs, and supplementary proposals for various ophthalmic products, and is well educated in all aspects of IOL clinical evaluation, product management, and development and commercialization processes.
FDA Approval of BBL Chromagar MRSA
BD Diagnostics Systems ( Sparks, MD) recently received FDA 510(k) clearance for its BBL Chromagar methicillin-resistant staphylococcus aureus (MRSA) product. The process of identifying MRSA colonization in patients, who may have retained postsurgical infections, is simplified by the chromogenic culture medium. BBL Chromagar MRSA also achieves direct detection and identification of most forms of MRSA within 24 hours less time than other current labor-intensive methods.
President Plans to Cap Malpractice Awards
On January 5, President George W. Bush announced his intention to limit malpractice damage awards to Congress. Bush's proposed campaign would restrict awarded damages for malpractice suits to $250,000, while still covering economic losses with unlimited damages. Similar legislation to put parameters on malpractice awards was passed by the House of Representatives last year, but was haulted in the Senate.
Bush spoke about physicians relocating from states where malpractice insurance premiums are high, or even leaving the profession. He also expressed trepidation about doctors avoiding possible suits by refusing patients with severe, complicated cases. "What's happening all across the country is that lawyers are filing baseless suits against hospitals and doctors ... And they're doing it for a simple reason: They know the medical liability system is tilted in their favor."
The President's agenda was met with disapproval from several groups. Democrats charge that Bush is rewarding the medical industry and insurance companies for having contributed so greatly to his own re-election. According to a press release, the new Senate Minority Leader, Nevada Democratic Senator, Harry Reid, stated "Congress should not be giving a free pass to big drug companies at a time when millions of Americans may have had their health put at risk by pharmaceutical giants," referring to the push of such drugs as Vioxx (Merck & Co., Inc., Whitehouse Station, NJ). Trial lawyers maintain that Bush is inventing a crisis while protecting insurance company profits.
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