At Press Time
ASC Owners Perform Far More Surgeries
New study raises questions of self-interest
By Jerry Helzner, Senior Editor
■ A University of Michigan study that totaled the number of various elective procedures performed in Florida ASCs over a three-year period found that physician-owners of these facilities did about twice as many surgeries as physicians who used ASCs owned by others. One finding was that ophthalmologist owners performed an average of 206 more cataract surgeries a year than non-owners.
In a telephone interview with Ophthalmology Management, the lead author of the study, which appeared in the April issue of Health Affairs, said most physician-owners might well be established, high-volume surgeons who can make the investment in an ASC and thus be able to refer their patients to their own facility, where they can assure patients of a high standard of care.
"We do recognize that patient volume is usually associated with making an investment in an ASC," said John Hollingsworth, MD, MS, a Robert Wood Johnson Clinical Scholar at the University of Michigan Medical School. "We are not making a judgment. We are just reporting the numbers."
However, the researchers also caution that "an ownership stake entitles physicians to a share of the facility's profits from self-referrals, which can create a potential conflict of interest between physicians' financial incentives and patients' clinical needs."
Dr. Hollingsworth said that one potential abuse is the possibility that physician-owners might lower the threshold for performing a procedure.
"With cataract surgery you have the criterion of impaired vision, but what is the threshold for recommending an arthroscopy for knee pain?" asked Dr. Hollingsworth.
The researchers say that any potential conflicts of interest could be resolved by revising federal law to require disclosure of investment arrangements; reducing facility payments to dilute ownership incentives; and reforms, such as accountable care organizations, that discourage an excessive rate of procedures.
"There are some definite advantages for surgeons, as well as patients, associated with care at surgery centers. However, we need to better understand the implications of these new findings, in particular their overall effect on healthcare expenditures. Insofar as our results are due to lowered treatment thresholds, policymakers should consider, at the very least, requiring all physicians to disclose their financial interests to their patients," Dr. Hollingsworth concluded.
The Museum of Vision Marks 30 Years
Anniversary offerings include online exhibits
By René Luthe, Senior Associate Editor
■ As part of its mission to preserve the history of ophthalmology, the Museum of Vision this year marks its 30th anniversary with a new searchable database and oral histories on its Web site, as well as special online exhibits. While the Web site (www.museumofvision.org) was launched in the mid 1990s to complement the actual Museum in San Francisco, it underwent its first major makeover this year.
"It hadn't changed much until this year, when we really rethought what people needed to see on the site," Jenny E. Benjamin, the Museum's director, explains.
Ophthalmic instruments from years gone by are of interest to today's eye surgeons. IMAGES COURTESY OF THE MUSEUM OF VISION
The additions were no easy task, as the Museum's collection of artifacts numbers approximately 38,000. Photographing and cataloging the items required years of effort in order to make the online database viable. Currently, the number of items in the database is "only" 18,000.
"So we have about 20,000 items that are still waiting to be placed online. I tell people who are disappointed that what we have online is only a taste of what's here, so just wait," Ms. Benjamin says.
Launched by the Foundation of the American Academy of Ophthalmology in 1980 shortly after its own inception, the Museum was the Foundation's first major project.
The Museum does not have a purchase fund, so its artifacts are all donations. Most come from ophthalmologists, though eyecare companies have also donated items.
"Usually, things come from doctors who are closing their practices," Ms. Benjamin explains. "Practices are often handed down from one generation to the next, so some of these items are family heirlooms."
Other items, such as amulets from ancient Egypt, are considerably older. More recently, the Museum received the personal papers of Marshall Parks, MD, considered the founder of pediatric ophthalmology, as well as the contents of his office.
"We're not just collecting things, we are collecting stories," Ms. Benjamin explains. "We are trying to keep an entire picture of the history of ophthalmology."
In keeping with that goal, another important addition to the Web site is previously unpublished biographies and an oral histories section. Past exhibits can also be found on the site, including the popular "To Fool the Eye," a collection of "quack" items. It was very popular with the public when the exhibit was at the Museum, Ms. Benjamin says, but physicians tend to favor examining the old-style instruments that are also displayed online.
Some backstories are familiar. A World War II airplane canopy in an exhibit case with an original Ridley lens, for example, immediately conjures the story of Dr. Harold Ridley working for the Royal Air Force during WWII when he noticed that shards from airplane canopies made out of a particular plastic were well-tolerated by the eye.
A vintage illustration in the collection shows instruction in instilling eye drops. IMAGES COURTESY OF THE MUSEUM OF VISION
"Of course, Dr. Ridley took that and an idea for replacing the lens during cataract surgery, and created the intraocular lens implant," says Ms. Benjamin. "He went straight to the company that made those airplane canopies and said, ‘I want that plastic.’ When physicians see those items together, they exclaim, ‘Oh!’ and know the story without being told."
The next exhibit, celebrating the Museum's 30th anniversary, will debut at the AAO's 2010 meeting in October. Ms. Benjamin anticipates that it will be online by November, as well as installed in the Museum.
Carl Zeiss Meditec Demonstrates All-Femtosecond Vision Correction
Investigational procedure eliminates the excimer
■ Carl Zeiss Meditec (CZM) has demonstrated the first femtosecondonly method of laser vision correction. The procedure, called ReLEx, is already commercially available in Europe. ReLEx allows ophthalmic surgeons to perform a variety of complete laser vision correction procedures using only the VisuMax femtosecond laser.
ReLEx procedures utilize precise laser cutting rather than excimer laser ablation. CZM says ReLEx allows for very small flap sizes, typically just 0.5 to 1 mm larger in diameter than the optical zone. Furthermore, CZM says ReLEx provides an easier and much faster workflow for the surgeon as the entire procedure can be performed using a single laser. To date, ReLEx procedures have been performed on more than 1,000 eyes at a variety of locations outside the US.
In a recent study in which the ReLEx Femtosecond Lamellar Extraction (FLEx) method was performed by Osama Ibrahim, MD, at ALEX Laser Center in Alexandria, Egypt, ReLEx compared favorably to LASIK in terms of efficacy, stability and safety. Overall, 102 eyes with myopia or myopic astigmatism with a spherical equivalent of −5.07 D ± 2.77 D were treated. At three-month follow-up, 95% of eyes treated were within ±1.00 D and 76% of eyes were within ±0.50 D of intended correction. Mean spherical equivalent was −0.17 D ± 0.64 D at one month. Stability was seen at one week postoperatively. A total of 85% of eyes achieved an uncorrected distance visual acuity (UDVA) of 20/20 or greater at one month and 84% showed UDVA of 20/25 or better at day one.
No change in corrected distance visual acuity (CDVA) was reported in 69% of eyes However, a gain of one or more lines was achieved in 9% of eyes. A loss of more than two lines occurred in 2% at one month.
�Until now, laser vision correction has been a two-part process in which the patient must be moved from one platform to another,� said Dr. Ibrahim. �With ReLEx using the VisuMax Femtosecond Laser, I achieved consistently excellent visual outcomes while enhancing patient comfort.�
Survey: ASC Infection Rates Too High
Re-use of disposable devices cited
■ Results are in from the first round of government inspections of infectioncontrol practices at ASCs and the news is not good, according to Outpatient Surgery. The publication reports that about two-thirds of the 68 surgery centers surveyed had at least one documented lapse in infection control and 18% had lapses in three or more of the five categories assessed by surveyors from CMS and the Centers for Disease Control and Prevention.
Improper hand hygiene, gloving, injection safety and equipment reprocessing were among the "suboptimal" practices discovered during the pilot round of infection-control surveys, according to findings presented at the International Conference on Healthcare-Associated Infections.
The improper re-use of single-use, disposable devices appears to have been a recurring problem unearthed during the surveys, which were conducted in Maryland, North Carolina and Oklahoma from June to October 2008. The findings show facilities were cited for using single-dose medication vials and other single-use devices for multiple patients. Other examples of lapses were failure to wash hands after contact with body fluids and failure to properly clean OR surfaces after procedures.
The researchers found no statistically significant association between infection-control lapses and the volume of procedures performed at an ASC or a particular facility type. Based on the findings, they conclude that "adherence to infection control in this sample of ASCs was suboptimal."
Research Digest
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Don't throw out that donor card. With corneal transplants up 22% in 2008 over the rate two years earlier, scientists at the Mayo Clinic in Rochester, Minn., set out to determine whether longer storage rates for corneal grafts had any effect on the success of transplants. Reporting their data in the April 2010 issue of Archives of Ophthalmology, the authors state that length of corneal preservation is not associated with graft failure or late endothelial failure (LEF).
The authors conducted an observational study of penetrating keratoplasties in 388 eyes over a 20-year period. Forty-one grafts were still available for examination at the 20-year mark. Among the findings was that graft recipients with keratoconous had a lower rate of graft failure and LEF than patients with endothelial dysfunction. Within those results, if patients with endothelial dysfunction had a lower preoperative cell density and a higher two-month endothelial cell loss, rates of LEF were higher.
The authors conclude that recipient diagnosis is a significant risk factor for success rates in corneal transplant, but corneal preservation is not. The authors suggest a randomized prospective study to confirm their results.
► Accommodating IOL pressure. Intraocular pressure decreases with accommodation in the eyes of myopic and emmetropic patients, according to a study in the March 2010 issue of the British Journal of Ophthalmology. Examining 15 nearsighted patients and 17 emmetropic patients with a mean age of 23±3 years, ophthalmologists at Queensland University of Technology in Brisbane, Australia, observed a mean change in intraocular pressure of −1.8±1.1 mm Hg. Changes in IOP were not statistically significantly different between myopic and emmetropic patients.
Furthermore, the study authors looked at ocular pulse amplitude (OPA) in both groups, finding that OPA decreased significantly with accommodation in both groups, with a mean change of −0.5±0.5 mm Hg. Myopic patients began with a significantly lower OPA and had a lower magnitude of change in the measurement.
The study adds data to the growing body of tomographic studies looking at IOP changes with accommodation. Noting that the largest change seen in one of the 33 patients was −3.7 mm Hg, the authors believe such changes could have clinical significance in disease management, as with the treatment of glaucoma.
► Makeup examination. Investigating a link between the use of cosmetics and symptoms of dry eye, doctors in Japan examined 75 female volunteers to determine rates of migration of materials from makeup into the eye — particularly when eye drops are used concurrently. The authors' paper appears in the April 2010 issue of Cornea.
The study authors divided the volunteers into three groups. In the first group, the "outer eyelash" group, had product materials applied on both eyelids 2 mm from the eyelash line. The second group, the "eyelash line" group, had product materials applied close to the eyelash line but not touching. The third group, "inner eyelash" group, had product materials applied on the eyelash line extending to the margin of the eyelids. The authors conducted slit-lamp examinations on all patients at the five- and 30-minute marks. In all cases, rather than applying actual cosmetic products, the study authors used a compound created in the laboratory in order to eliminate product bias.
The authors found that, in the inner eyelash group, migration and contamination were significantly higher at five minutes when compared to the other two groups. At 30 minutes, migration and contamination had gone up significantly in the eyelid line group as well.
In a separate part of the experiment, even the outer eyelash group exhibited significant migration and contamination rates when eye drops were instilled five minutes after application of cosmetic product materials. Based on these results, the study authors suggest that contamination of the ocular surface by cosmetic products could be a contributing factor for inducing or worsening dry eye.
► Zero ounces of prevention. Are the vitamins promoted for prevention of eye disease actually effective? The latest report from the Age-Related Eye Disease Study (AREDS) says that, as far as the healthy population goes, they aren't.
Writing in the May 2010 issue of Current Opinions in Ophthalmology, retinal physicians from the National Eye Institute in Bethesda, Md., state that there is currently insufficient evidence to recommend that healthy patients supplement their diets with AREDS-style vitamins. However, patients with risk factors for intermediate age-related macular degeneration or with advanced AMD in one eye already are encouraged to take the supplements. In particular, these patients should supplement their diets with vitamin C, vitamin E, beta carotene and zinc with copper.
Furthermore, the article states, it may be a good idea for at-risk patients to take supplemental macular xanthophylls and omega-3 fatty acids. Although the AREDS team has not yet analyzed data on these supplements, an AREDS 2 study is now under way that will evaluate these compounds in patients at risk for advanced AMD. This study will also look at the effect of lutein on volunteer eyes.
What gives the current study greater weight than other studies is its provenance: AREDS is the only large-scale, randomized, controlled clinical trial to show a 25% beneficial effect of nutritional supplementation in reducing the risk progression to advanced AMD in patients with intermediate AMD or with advanced AMD in one eye. OM
In the News…■ Crystalens AO gets NTIOL status. Bausch + Lomb's Crystalens AO has received new technology intraocular lens (NTIOL) classification from CMS. The Crystalens AO is the first accommodating IOL with aspheric optics and was approved by the FDA in late 2009. The NTIOL classification, which became effective April 9, means that the Crystalens AO is approved for an additional $50 Medicare payment adjustment for services in conjunction with cataract procedures performed at an ASC. ■ Lenstec IOL approved. The FDA has approved Lenstec's Softec HD IOL. The lens has a tolerance of 0.125 D and is available in 0.25 D increments. The company asserts that these two attributes produce a precision lens that has the ability to target each patient's prescription. The Softec HD is part of the "Precision Series" of lenses manufactured by Orlando-based Lenstec. ■ CZM gets OK on visual fields software. Carl Zeiss Meditec announced that the FDA has granted a 510(k) Class II clearance for the Humphrey Field Analyzer II with Guided Progression Analysis (GPA) software. CZM says the automated perimeter is now the only FDA-approved perimeter with GPA software to specifically assess the rate of visual field loss over time. ■ EyeSupply named distributor. EyeSupply USA, Inc., said it has been named the exclusive distributor of the new proprietary fluorescein sodium and lissamine green dye combination, Fluramene. EyeSupply says Fluramene, a sterile solution packaged in a 15 ml bottle with a control tip dropper, provides the clinician with a tool to simultaneously evaluate the conjunctiva and the cornea for ocular surface disorders without additional drops or dye strips. ■ AMO receives customer service award. Abbott Medical Optics has received the Omega NorthFace ScoreBoard Award for the 9th time in the 10 years this award has been given. The award is presented annually to 25 companies who, as rated by their own customers, achieved the greatest excellence in customer satisfaction during the prior calendar year. ■ Columbia U. has new ophthalmic center. The Columbia University Department of Ophthalmology has a new midtown Manhattan location, a comprehensive eyecare facility called the Gloria and Louis Flanzer Vision Care Center. The new center, which occupies the entire second floor of 880 Third Avenue at East 53rd Street, consolidates and expands Columbia's several ophthalmology practices located around midtown into one location and will give patients convenient access to general ophthalmologists and specialists who focus on cornea, cataract, glaucoma, oculoplastics and retina diagnosis and treatment. ■ Self-massage helps lower IOP. Researchers at Toronto Western Hospital in Ontario, Canada, taught 18 glaucoma patients, who had Ahmed valves implanted, a digital ocular massage technique intended to further lower IOP. After six months, half of the patients were able to lower their IOP by an average of 20% (approximately 4.4 mm Hg) and sustain that improvement. The rest of the patients in the study were deemed non-responders to this technique. One caveat: Glaucoma specialists caution that patients who use this technique must be properly instructed and monitored so that they do not lower IOP too much. The research was reported in a recent issue of the Journal of Glaucoma. ■ Iontophoresis for anterior uveitis. EyeGate Pharma, said it has completed an encouraging phase 2 study of its lead product candidate, EGP-437, for the treatment of anterior uveitis. The study employed a novel non-invasive drugdelivery technique called iontophoresis, which uses small electronic charges to improve drug penetration into the eye. Iontophoresis has been described as an injection without a needle. Patients received a single dose of EGP-437 (a dexamethasone-derived corticosteroid solution) delivered at one of four dose levels and were then followed for 28 days. Following the single EGP-437 treatment, about half of the subjects achieved an anterior cell score of zero within two weeks. By day 28, the majority of patients achieved cell scores of zero and required no further treatment. No significant changes in intraocular pressure or signs of cataract formation were detected. ■ B+L launches AREDS 2 vitamins. Bausch + Lomb is introducing PreserVision Eye Vitamin and Mineral Supplement AREDS 2 formula. This builds on the original AREDS formula, replacing betacarotene with lutein (10 mg) and zeaxanthin (2 mg) and adding omega-3 fatty acids (1000 mg) per daily dosage. Studies show that the inclusion of high levels of omega-3 fatty acids, lutein and zeaxanthin in the diets of at-risk patients reduces the risk of developing AMD. ■ Home AMD monitor approved. After successfully completing clinical trials, Notal Vision's ForeseeHome AMD Monitor has received Section 510k clearance from the FDA. The ForeseeHome AMD Monitor is the first ophthalmic device linking patients and doctors between eye exams for ongoing detection and monitoring of AMD. Patients complete a frequent but brief exam on the ForeseeHome Monitor in their own home, with data transmitted to the patients' eyecare physician and the Notal Vision Data Monitoring Center. ■ LenSx gets clearance on femtophaco. LenSx Lasers, Inc., a developer of femtosecond technology for cataract surgery, has received FDA clearance of its LenSx femtosecond laser for laser phacofragmentation during cataract surgery. The company says this third LenSx clearance will allow the computer-guided LenSx laser to perform another critical step of the cataract procedure. Stephen G. Slade, MD, of Houston, who performed the initial series of LenSx procedures in the US, stated "the LenSx phacofragmentation clearance is an important milestone in delivering the benefits of laser refractive cataract surgery to patients, including the reduced use of ultrasonic power to fragment and remove the cataractous lens." In a study, LenSx phacofragmentation resulted in a 43% reduction in average phaco power and a 51% reduction in effective phaco time. According to LenSx, additional reported benefits of its technology include the ability to deliver a perfectly centered and sized capsulotomy, resulting in more reproducible positioning of the IOL and in the potential for reduced dependence on glasses. ■ Eyemaginations opens California office. Eyemaginations, Inc., which provides innovative patient education materials to ophthalmologists and other medical specialties, has announced the opening of a new office in Century City in Los Angeles to support growing sales of its software products. With nearly 10,000 physician clients in over 90 countries worldwide, Eyemaginations says its technology has played an important role in healthcare providers' communication process. ERRATUMIn the feature "EMR: Finding a Vendor Who Tailors to Fit" (March 2010), the "Workflow vs. Template Design" discussion was used with permission from Ophthalmic Imaging Systems' "EMR Countdown" newsletter, but was not acknowledged in print. The missing reference should read "Info provided by OIS. www.oisi.com/index.php?option=com_content&view=category&lay out=blog&id=90&Itemid=192." |