At Press Time
New Center for Combat Eye Injuries
The Initiative Moves Ahead — But Slowly.
By Jerry Helzner, Senior Editor
■ When Congress passed legislation early in 2008 authorizing the creation of the Defense Vision Center of Excellence (known as the VCE) and a related combat eye injury registry, veterans' issues advocates were heartened that the 60,000 members of the U.S. military who had sustained serious eye injuries in the previous decade would be getting some much-needed government attention.
In addition, the VCE would serve as the focal point for coordinating research and treatment of combat eye injuries, thus advancing a knowledge base that could be used to develop future treatment options. With the U.S. military currently deeply engaged in both Iraq and Afghanistan, efforts to provide better treatments for the many eye injuries primarily caused by the improvised explosive devices known as IEDs would appear to be a priority.
However, somewhere in the federal bureaucratic maze that allows some initiatives to be overfunded and others not funded at all, a headline-making traumatic brain injury center received $60 million in 2008 while the VCE got none of the $5 million that had originally been allotted.
"Until February of this year a total of only $7,000 had been spent on the VCE," says Thomas Zampieri, Ph.D., director of government relations for the Blinded Veterans of America (BVA).
Fortunately for the veterans, Col. Donald Gagliano, M.D., a retina specialist, was named executive director of the VCE late in 2008. He began speaking to members of Congress about the lack of vision center funding. With Dr. Gagliano, the BVA and the American Academy of Ophthalmology (AAO) raising the issue, Congress allocated $3 million to fund VCE operations for the remainder of fiscal 2009. However, another $4 million to construct permanent office space for the VCE at Bethesda National Naval Medical Center has been held up until now in bureaucratic wrangling.
"Bethesda is the perfect place for the VCE because it is where the combat injuries are actually being treated," notes Dr. Zampieri.
Despite these issues, Dr. Gagliano recently told Stars and Stripes that progress was being made in making the VCE a functioning entity.
"We've made huge leaps recently," he said. "The Defense Department is taking us seriously now."
At the recent American Academy of Ophthalmology Advocacy Day, the VCE was made a priority issue, with the AAO asking Congress to include a $6.8 million line item in VCE funds in the 2010 budget.
"We are asking for this line item to avoid similar funding difficulties for the VCE in fiscal 2010," says Cathy Cohen, vice president of governmental affairs for the AAO. "The VCE will serve as a central resource that will be able to efficiently perform vital research, recommend best practices and develop outcome measures for combat-related eye injuries."
Dr. Zampieri said that fiscal 2010 VCE funding looks to be assured.
"We really need the VCE to be up and functioning as soon as possible because the new buildup of American troops into Afghanistan will almost surely lead to an upsurge in combat-related eye injuries," asserts Dr. Zampieri.
| IN THE NEWS |
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| ■ Flomax linked to postoperative adverse events. A large-scale Canadian study has shown that men taking tamsulosin (Flomax) for benign prostatic hyperplasia (BPH) are at higher risk for adverse events following cataract surgery than men taking other alpha-blocking medications for BPH. Flomax has already been associated with an intraoperative complication known as Intraoperative Floppy Iris Syndrome (IFIS) but this is the first large study of postoperative complications. Researchers led by Chaim Bell, M.D., Ph.D., of St. Michael's Hospital, Toronto, reported in the Journal of the American Medical Association that in more than 96,000 cataract surgery patients evaluated, those who were recently dispensed tamsulosin had 2.3 times the risk of postoperative adverse events such as retinal detachment, lost lens, lens fragments or suspected endophthalmitis. A JAMA editorial accompanying this new research suggested a "black box" warning cautioning against taking alpha1-adrenergic blockers before cataract surgery. The drug's patient information insert does advise patients considering cataract surgery to inform their surgeon that they are taking Flomax and that surgeons should be prepared to possibly modify their surgical technique. ■ B&L finalizes refractive joint venture. Bausch & Lomb and 20/10 Perfect Vision AG, a femtosecond laser developer, have formed a joint venture focused on the laser vision correction industry. The new company — Technolas Perfect Vision — combines the refractive surgery assets of both businesses and will utilize its global infrastructure to introduce new, laser-based vision correction procedures. Initially focusing on treatments for presbyopia, Technolas Perfect Vision will provide clinicians with advanced excimer and femtosecond laser technology designed specifically to restore near vision in those patients. One new procedure is Intracor, an intrastromal treatment designed to restore near vision. Intracor now carries the CE Mark for the treatment of presbyopic hyperopes. Studies evaluating an even broader range of indications are already underway. Intracor is not yet approved in the United States. ■ Dysport approved for frown lines. The FDA has approved Dysport, a botulinum-toxin product, as a treatment for moderate-to-severe glabellar (frown) lines in patients under the age of 65. Dysport, which was studied in clinical trials involving more than 2,900 patients at 80 sites, was developed and commercialized by a partnership involving the French company Ipsen and U.S.-based Medicis. The product will be marketed in the Unites States by Medicis for the frown-line indication. A number of ophthalmologists have expanded into aesthetic procedures in recent years. Until now, Allergan's Botox had been the only approved botulinum toxin for the treatment of frown lines. In a related action, the FDA asked all makers of botulinum toxins to update their labeling to make it clear that their products are not interchangeable and also to state that there are risks associated with unapproved uses of these products. ■ New Cirrus OCT applications approved. The FDA has granted clearance to the latest version of Carl Zeiss Meditec's Cirrus HD-OCT software, the 4.0. The new software offers features for tracking changes in glaucoma and managing retinal disease, the company says, as well as for supporting cataract and refractive surgeons. These include anterior segment imaging of the cornea and angle, with central cornea thickness measurement for glaucoma management without the need for external lenses, as well as guided progression analysis software that compares retinal nerve fiber layer (RNFL) thickness measurements over time and determines if statistically significant change has occurred. These results provide event analysis, trend analysis and a quantified rate of change. In addition, the new software offers normative RNFL and macular thickness data to allow clinicians to identify pre-existing glaucoma and retinal disease, as well as rule out suspected glaucoma, plus change analysis that allows physicians to monitor disease progression and therapeutic outcomes for both glaucoma and retina. Macular change analysis provides visual and quantitative comparison of two retinal exams. ■ Healon D on Hold. Abbott Medical Optics has withdrawn its Healon D viscoelastic, explaining that the "manufacturing process is limiting our ability to ensure a continuous supply of product to the market at this time." Because the product "uses a unique set of raw materials sourced from a third-party provider and is manufactured using a process also unique to this product," the company's other viscoelastic products will not be affected, said an AMO spokesman. Healon, Healon GV and Healon 5 remain available to U.S ophthalmologists. Though AMO did not provide an estimated date or timeframe for Healon D's return to the market, the company said that it is "taking proactive steps" to ensure its eventual return. ■ AzaSite studied for blepharitis. Inspire Pharmaceuticals said a small 4-week study of its anti-infective AzaSite (azithromycin ophthalmic solution 1.0%) resulted in a significant reduction in the most common eyelid bacterial flora and provided significant improvement in both signs and symptoms in patients with chronic blepharitis. Inspire has now initiated two phase 2 randomized placebo-controlled, multicenter trials, each conducted on 300 subjects with blepharitis at approximately 30 clinical sites. One evaluates the safety and efficacy of 2 weeks of treatment with AzaSite compared to placebo while the other evaluates the safety and efficacy of a 4-week regimen compared to placebo. The trials will evaluate various signs and symptoms of blepharitis as well as safety and tolerability. AzaSite is already approved by the FDA for treatment of bacterial conjunctivitis. ■ B&L IOL gets NTIOL status. Bausch & Lomb said CMS has granted NTIOL designation to the company's Akreos Advanced Optics Aspheric (Akreos AO) IOL for its spherical aberration reducing design. NTIOLs are lenses designated by CMS as providing new clinical benefits. ■ TearLab system gets OK. Ophthalmic diagnostics company TearLab Corporation announced FDA 510(k) clearance of its TearLab Osmolarity System, intended to measure the osmolarity of human tears to aid in dry eye diagnosis, in conjunction with other methods of clinical evaluation. Tear osmolarity has been shown to have a high accuracy and predictive value for diagnosing dry eye. The clearance allows the company to immediately begin marketing activities in the United States to clinical facilities categorized as high or moderate complex under the Clinical Laboratory Improvement Act of 1988. The company recently began a 13-site validation study of the system's efficacy that will enroll up to 500 subjects worldwide. The study will allow clinicians to understand and use the TearLab reading appropriately, as well as to benchmark tear osmolarity against commonly used diagnostic tests (e.g., lissamine green, Schirmer strips, tear break-up time). The secondary objective will be to establish the relationship between osmolarity values and severity of dry eye disease, as well as age and gender, among other factors. ■ Eye bank/research institute. The Tampa Lions Eye Institute for Transplant and Research has announced plans to open a new 12,000-square-foot facility in Tampa that will offer high-volume, high-quality human ocular tissue for research, study, collaboration and clinical advancements. The facility will also have extensive space for onsite residence, sleeping quarters and meetings/events. This marks an expansion of what is already the world's largest eye bank. |
LASIK Declines as Economy Slumps
Data From 2008 U.S. Trends in Refractive Surgery Survey
By Leslie Goldberg, Associate Editor
■ LASIK procedure volume in the United States in 2008 was approximately 721,000 eyes, continuing a steady drop from a high point of about 950,000 in 2004, according to the U.S. Trends in Refractive Surgery: 2008 ASCRS Survey conducted by Richard J. Duffey, M.D., of Mobile, Ala., and David Leaming, M.D., of Palm Springs, Calif. Data from the survey, now in its 13th year, were presented at the recent ASCRS annual meeting in San Francisco.
Analysts ascribe the decline to the slumping economy and its effect on elective surgery. The drop in LASIK procedures was especially sharp in 2008, as compared to the more than 800,000 eyes that underwent LASIK in 2007. On a brighter note, PRK procedures held nearly steady in 2008, with 228,000 eyes close to matching the 2007 figure.
In his presentation, Dr. Leaming noted that 17% of the membership was performing LASIK in 1997 and by 2000 the figure rose to 60%. Currently, 41% of members are performing LASIK. Additionally, 60% of members are using presbyopic IOLs, up from 48% in 2006.
According to the survey, one-third (32%) of surgeons measure true flap thickness in the OR and the most desired flap thickness is 120 μm to 130 μm (50%) while a 100 μm flap thickness is favored by 32% of surgeons (up from 11% 3 years ago). The minimum preop corneal pachymetry acceptable for LASIK (with all other parameters normal) is 500 μm, according to 44% of the 634 respondents (13% of the U.S. ASCRS membership), 31% require 480 μm, 11% said 460 μm, 9% said no limit and 4% said 520 μm.
Half of surgeons are not "OK" performing LASIK in corneas <500 μm. Monovision is the most sought-after goal for presbyopic patients seeking refractive surgery, with 43% of respondents choosing that result.
LASIK volume showed a steep decline in 2008.
Other findings included:
► Refractive surgeons are four times more likely to have LASIK surgery than the general population.
► About one-third (35%) of surgeons surveyed have had one or more documented cases of post-LASIK ectasia in their patients over a career. (This number is not increasing.)
► Fourth-generation fluroquinolones dominate the post-refractive surgery market (96%).
► Co-management is practiced by under one-half of respondents (44%), with most of these co-managing less than one-third of their patients.
► When co-managed, LASIK patients are seen 1-day postop by their surgeon 74% of the time and by a co-manager 26%.
Dr. Duffey's survey results are posted at www.duffeylaser.com and Dr. Leaming's results are available at leamingsurveys.com.
RESEARCH DIGEST
New and noteworthy studies impacting clinical practice.
By Andrew E. Mathis, Ph.D., Medical Editor
■ Avastin for the Cornea? Off-label use of bevacizumab (Avastin) to treat wet AMD has become commonplace since Dr. Philip Rosenfeld's team at Bascom Palmer Eye Institute published their first paper on the topic in 2005. Now, a study published in the April 2009 edition of Archives of Ophthalmology indicates that bevacizumab may be effective in arresting neovascularization of the cornea.
Doctors at the Schepens Eye Institute at Harvard University treated 10 patients with stable corneal neovascularization with bevazicumab 1.0% for 3 weeks and then followed up the patients for 24 weeks. The researchers found statistically significant decreases in neovascular area and vessel caliber at 24 weeks. Changes in invasion area were also observed, but these were not statistically significant. No systemic or local side effects were observed.
While more studies are needed, these initial data may indicate a role for VEGF — believed the principal culprit in neovascular AMD — in corneal neovascularization.
■ And for Glaucoma? A Bascom Palmer team, including Dr. Rosenfeld, has published its findings on the use of Avastin in neovascular glaucoma (NVG). The study, which appears in the May issue of the British Journal of Ophthalmology, was a case series of 56 eyes in 52 patients for whom mean IOP dropped from 40 mm Hg to 18 mm Hg.
While the authors note that intravitreal injections of Avastin are now frequently used to treat NVG, many patients still require other IOP-lowering therapies, including surgery, as did many of the subjects of this case series. Greater efficacy was correlated with earlier detection of NVG and consequent Avastin interventions.
■ Circular keratotomy stabilizes astigmatic eyes. A German surgeon and his American colleague have published in the April 2009 issue of the Journal of Refractive Surgery a retrospective analysis of eyes that underwent circular keratotomy for stage 1 and stage 2 keratoconus, finding the process resulted in significant reductions in astigmatism and improved BCVA. Jorg H. Krumeich, M.D., of the Clinic Krumeich in Bochum, Germany, operated on 46 eyes from 36 patients between 1993 and 2006. In patients with astigmatism, 64% of 28 eyes treated were stabilized both at 1-year follow-up and at the latest reported appointment, all of which took place at at last 2 years. Changes in BCVA ranged from no change (20/20 remaining the same) to 20/632 to 20/125, with a mean change of 20/44 to 20/33. While the authors concede more studies are needed, it seems circular keratotomy is a reliable method for stabilizing astigmatism and improving BCVA.
■ ED drugs get clean bill. According to a new study in the Archives of Ophthalmology, 244 men who took either 50 mg Viagra, 5 mg Cialis (both PDE5 inhibitors), or placebo daily for 6 months were monitored by electroretinograph to detect any anatomical or visual changes, and none were found. These data are in opposition to earlier studies that had found that PDE5 inhibitors had potential for retinal toxicity.
■ Infrared iris photography offers earlier diagnostic tool. A team of researchers from Illinois and Michigan have published in the March/April 2009 issue of Ophthalmic Surgery, Lasers & Imaging several examples from a 6-year case series of 310 subjects who underwent digital infrared iris photography. Patients with a variety of ocular disorders, including cataract, diabetic retinopathy and ocular trauma, as well as healthy patients for controls, had their eyes photographed with infrared technology, which is known to be more sensitive in detecting iris transillumination defects.
Among the cases reported by the researchers are cases of pigment dispersion syndrome (PDS), the second most common condition seen in this study after long anterior lens zonule phenotype. If untreated, PDS can commonly lead to pigmentary glaucoma. That infrared iris photograph is more sensitive to detecting PDS is particularly important in this study because 85% of the subjects in this case series were African-American, and glaucoma is the leading cause of vision loss among African-Americans.
■ Ultraviolet laser study. While infrared femtosecond corneal refractive surgery has been established over several years for flap creation in LASIK, the development of ultraviolet femtosecond laser technology is relatively recent. The IntraLase FS femtosecond laser is the first such ultraviolet laser of its kind approved by the FDA. Using this laser, a team of scientists in Germany have published their results on pig eyes in the April 2009 issue of the Journal of Refractive Surgery.
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