At Press Time
AAO/ASCRS Begin IFIS Outreach
Surgeons See Alpha Blockers Posing Higher Surgical Risk.
By Jerry Helzner, Senior Editor
■ Armed with new surgeon survey data in which three-quarters of respondents believe that tamsulosin (Flomax) increases the risk of cataract surgery complications, the American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy of Ophthalmology (AAO) are making sure that primary care doctors are aware of the association of Intraoperative Floppy Iris Syndrome (IFIS) with alpha blockers, such as tamsulosin.
A joint statement issued by ASCRS and AAO notes that "IFIS has also been reported with non-subtype-specific alpha-1 adrenergic antagonists, such as terazosin (Hytrin), doxazosin (Cardura) and alfuzosin (Uroxatral). However, several prospective and retrospective studies suggest that IFIS is more likely to occur with tamsulosin than with the non-specific alpha blockers." The joint educational statement and the survey results were recently circulated by the American College of Physicians and the American Academy of Family Physicians to their members.
According to the online survey sent to ASCRS members, 95% of the nearly 1,000 respondents believe that tamsulosin makes cataract surgery more difficult and 77% believe it increases the risks of surgery. Specifically, cataract surgeons reported an increased rate of significant iris damage (52% of respondents) and an increased rate of posterior capsule rupture (23% of respondents) in eyes with IFIS during the past 2 years. Of those respondents with sufficient experience to judge, 90% believe that IFIS is more likely to occur with tamsulosin than with non-specific alpha blockers. Many ophthalmologists (59%) would recommend an ophthalmic evaluation for patients with a history of cataracts or decreased vision prior to initiating treatment with tamsulosin. Overall, nearly two-thirds of survey respondents would either avoid taking tamsulosin if they themselves had cataracts (41%) or would have their cataract removed first (23%).
"We're not presenting the member survey as a level 1 scientific study," says David Chang, M.D., chair of the ASCRS Cataract Clinical Committee and clinical professor of ophthalmology at the University of California, San Francisco. "However, it does provide a snapshot of cataract surgeons' clinical experience with IFIS and points to their diversity of opinions and experiences with a variety of surgical problems that alpha blockers cause." Dr. Chang and John Campbell, M.D., first reported on IFIS and its association with tamsulosin in 2005. "For patients with cataracts, we are asking the prescribing physician to consider involving the cataract surgeon before the decision is made to start an alpha blocker," Dr. Chang says. "The eye surgeon can assess not only how advanced the cataract is, but also how much risk an alpha blocker might add, particularly in light of other co-morbidities."
Asked for his personal opinion about possible alternatives to tamsulosin, Dr. Chang said that Uroxatral is a different uroselective alpha blocker that appears to be less likely to cause IFIS. He adds that one alternative class of drugs that can be considered for patients with cataracts would be finasteride (Proscar) or dutasteride (Avodart). Dr. Chang notes that finasteride is not an alpha blocker and actually shrinks the prostate over time by blocking production of the hormone dihydrotestosterone. Compared to alpha blockers, however, it takes longer for the urinary symptoms to improve. "The largest ever prostate cancer prevention trial showed that finasteride reduced the risk of prostate cancer by 25 to 30% and new statistical data was recently reported that further strengthens this conclusion," says Dr. Chang. "This new data may lead to increasing use of finasteride for BPH, which would certainly reduce the risk of IFIS as a side benefit."
A Colleague Remembers Dr. Shugar
Dr. Gayton Recalls a Caring, Innovative Physician.
By Johnny Gayton, M.D.
■ On Memorial Day of this year, one of the brightest minds in ophthalmology, Dr. Joel Shugar, met an untimely death doing something he loved dearly. Joel was the leader of Optic Nerve, a national championship skydiving team. He was almost as passionate about skydiving as he was about ophthalmology.
I first met Joel many years ago as a result of the "piggyback" procedure. He and I had used piggyback lenses to help improve the visual acuity of numerous patients in north Florida and south Georgia. We were dismayed a few years later to discover that many of our patients were developing opacification between the implants. I figured out that the cause was epithelial cells growing between the implants, but it was Joel's keen sense of observation that determined how to prevent it.
He observed that patients with a capsulorrhexis larger than the anterior lens optic and patients with one lens in the sulcus did not develop the problem. That observation kept the piggyback procedure from becoming a historical footnote and has allowed it to continue to help many patients, including premium lens patients. I will be forever indebted to him for that observation. Shortly after working with me on the piggyback, Joel wrote me and asked for permission to use one of my nicknames in ophthalmology. I readily agreed, and we jokingly became the "High-Tech Rednecks" of ophthalmology. We adopted this pseudonym not out of political persuasion, but because we both lived in rural areas and enjoyed high-tech equipment and toys.
Dr. Shugar was born in Albany, N.Y. He earned an M.S. degree in Electrical Engineering. He received his M.D. from SUNY/Buffalo School of Medicine. He served his internship in internal medicine in Buffalo and completed his residency in ophthalmology at the University of Florida. From there, he founded the Nature Coast EyeCare Institute in Perry, Fla., and became one of the nation's top eye surgeons.
Joel made many other contributions to our profession. He wrote 65 articles, was a regular contributor to online discussions and was the developer of both Shugarcaine and Epi-Shugarcaine. These solutions are used by eye surgeons all over the globe to make cataract surgery more comfortable and safer for patients. Epi-Shugarcaine's usage is continuing to increase because of its effectiveness in stabilizing the iris in IFIS patients.
Dr. Joel Shugar
Joel was also known in North Florida for his "Gift of Sight" program. Two days before Thanksgiving each year, he would perform cataract surgery on needy patients. More than 300 people have benefited from the program. His practice would like other practices to continue with that program in his memory. If we would all do at least one charity case at Thanksgiving in his memory, thousands of needy patients would be able to see. What a wonderful way to remember a colleague who unselfishly gave of his time to help us better care for our patients and worked tirelessly to help needy people in his area.
Next-generation Crystalens Approved
Clinical Data Show Improvement in Near Vision.
■ Bausch & Lomb said that it has received approval from the FDA to market the next-generation Crystalens HD accommodating, presbyopia-correcting IOL in the United States.
The first Crystalens was approved by the FDA in November 2003, with the Crystalens HD being the fourth generation of the only FDA-approved accommodating lens.
The surface of the Crystalens HD has been shaped to enhance the depth of focus with a proprietary optical modification. The enhanced optic is designed to improve near vision without compromising intermediate or distance vision. Bausch & Lomb says the HD lens does this without inducing increased undesirable dysphotopsia or night vision symptoms.
The new Crystalens HD
A total of 125 primary eyes were implanted with the Crystalens HD in patients who had a visually significant cataract, less than 1 D of corneal astigmatism and the potential for BCVA of 20/25 or better in both eyes. Of these patients, 80% reported vision at J2 or better at 4 months.
"Extensive market research has clearly indicated that patients and surgeons alike are asking for a truly accommodating IOL as their choice of lens. With these results, where patients reported getting one more line of near vision, we are coming ever closer to meeting the desired need for an optic that does provide truly good near vision without compromising the quality of vision at intermediate or distance," said Michael Judy, chief marketing officer at Bausch & Lomb Surgical.
Bausch & Lomb said that surgeons should continue to use the same surgical protocols for the Crystalens HD as they have used in the past. The company began shipping the Crystalens HD in early July.
| IN THE NEWS |
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| ■ Sirion gets first drug approval. Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, said that the FDA has approved its new drug application for Durezol (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a 6-month priority review. Sirion said that in two phase 3 trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol rapidly reduced inflammation and pain. Mean IOP for all study groups remained within the normal range throughout the study. "It is important to point out that in these phase 3 studies, patients were dosed for the first time after the ocular trauma from surgery had occurred, said Michael Korenfeld, M.D., assistant clinical professor of Ophthalmology and Visual Sciences at Washington University in St. Louis, Mo, and principal investigator for the phase 3 trials. "The results from these studies, particularly the ability to eliminate postoperative pain, demonstrate that Durezol is a powerful option for postoperative care." Sirion plans to make Durezol commercially available in late 2008. ■ Medicare fee cuts reversed. Sen. Edward Kennedy made an emotional return to the Senate and then cast a key vote that helped reverse a 10.6% cut in Medicare physician fees scheduled to go into effect in July. Congress has voted to replace the fee cuts with a positive 0.5% update this year and a 1.1% fee increase for 2009. President Bush vetoed the legislation but his veto was quickly overridden. ■ OPKO acquires "pink eye" treatment. OPKO Health, Inc. has acquired exclusive worldwide rights to a novel small-molecule agent in phase 2 clinical development for the treatment of viral conjunctivitis and other viral infections. The agent, CTC-96, also known as Doxovir, was developed by Redox Pharmaceutical Corporation. It is a member of a novel drug class that OPKO says has demonstrated potent anti-viral activity and nonsteroidal anti-inflammatory properties. OPKO says the compound has demonstrated good safety in preclinical and human clinical testing. ■ FDA panel makes recommendations on contact lens solutions. Acting on suggestions from the ophthalmic community, the FDA Ophthalmic Devices Panel has recommended that makers of contact lens solutions provide stricter labeling and conduct more thorough testing to prevent eye infections. At a June meeting, panel members agreed that incidents of eye infections in the past 2 years involving Advanced Medical Optics and Bausch & Lomb cleaning solutions have primarily stemmed from contact lens wearers failing to follow manufacturers' directions on proper use of these solutions. The panel suggested more explicit instructions to consumers, including warnings not to reuse cleaning solution, putting discard dates on lenses and a recommendation to replace contact lens cases frequently. One recommendation offered by the panel is that all cleaning solutions carry "rinse and rub" instructions. Most practitioners advocate rubbing to remove dirt and bacteria from the lens but some solutions have been advertised as "no rub." ■ DSAEK for children. A new corneal transplantation technique offers the hope of improving vision for children with blinding corneal disease while overcoming the technical difficulty and low success rate of traditional penetrating keratoplasty in children, according to a report in the Journal of the American Association for Pediatric Ophthalmology and Strabismus. A recent issue includes two case reports on the successful use of Descemet stripping automated endothelial keratoplasty (DSAEK) in children with corneal disease. If the promising results are borne out by further research, DSAEK could provide an alternative to traditional corneal transplantation — a notoriously difficult procedure in children, failing more often than it succeeds. OM |
Corporate LASIK Feels Pinch
LCA-Vision Sees Sharp Drop in Procedures.
■ The economic slowdown is taking its toll on LCA-Vision, the country's largest provider of so-called corporate laser vision correction.
Despite the addition of several new "LasikPlus" centers to a chain that currently has 76 locations, the company recently reported that year-over-year procedure volume dropped by approximately 38% in the 3-month period that ended June 30.
"Macro-economic conditions continue to negatively impact consumer confidence and discretionary spending, leading to continued softness in LasikPlus appointments by prospective patients and disappointing show rates," said Steven C. Straus, CEO of LCA-Vision. "We also believe that media coverage leading up to and following the April 25, 2008, Food and Drug Administration Ophthalmic Devices Panel negatively impacted our business in May and June."
The Ophthalmic Devices Panel held a hearing on LASIK "quality-of-life" outcomes in April after receiving complaints from individuals who had undergone LASIK and were dissatisfied with the results. Though the complaints came from a small minority of LASIK patients, some of the vision problems described at the hearing were quite serious.
"On the positive side, IntraLase is available in 73 of our 76 LasikPlus vision centers and month-to-date is being utilized in about 69% of our procedures, up from 55% in March," Straus said. "We continue to expand our market presence, and have plans to open our 77th and 78th LasikPlus vision centers during the third quarter, which will bring our 2008 new center openings to six. We also plan to relocate three or four older locations by the end of this year. We are committed to success at each LasikPlus vision center and have no plans at this time to close any facility."
According to Anthony Woods, LCA-Vision's chairman, "The LCA-Vision Board of Directors strongly supports the executive management team in affirming the strategic direction of the company. We are committed to our business model and our strategy. Consumers are confronted with record-high gasoline prices, increasing food costs and declining home values in the face of a softening economy and growing job uncertainty. Many Americans are reining in their expenses, and are deferring or eliminating purchases that just 1 year ago they viewed differently. In this environment, there is no quick fix to restoring growth in procedure volume, but, rather, we will focus on proven strategies, while we prudently explore new opportunities to maximize effectiveness throughout our organization."
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