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Tackling the Vision Problems of Older Drivers
Conference Explores Ideas for Keeping Seniors on the Road Safely.

There are currently 13 million drivers in the United States who are over the age of 70. By 2020, that number will swell to about 38 million, making this cohort the fastest growing segment of the driving population.

With studies showing that seniors have the highest percentage of accidents per mile driven and are judged at fault in a high number of multiple-vehicle intersection accidents, auto manufacturers are starting to search for ways to keep drivers with the typical vision problems of the elderly safely behind the wheel.

As an example of the driving problems encountered by aging motorists, the Institute of Ophthalmology in London, England, found that even normal age-related changes to the eye create dramatic changes in sensitivity to headlight glare.

Studies have also shown that seniors find it increasingly difficult to read road signs, causing them to have a tendency to slow down in heavy traffic and cause rear-end accidents.

Among the solutions suggested:

• clearer basic dashboard displays
• night vision devices with dashboard displays (already available in some models; see photo at top right)
• polarized headlights and windshields to reduce glare
• more readable, high-contrast blue-and-orange road signs (already used in parts of Europe)
• more attention to older drivers and their needs in the automobile design testing process
• licensing programs that would allow vision-impaired individuals to drive specially designed, low-speed cars on local roads only.

"As this large demographic group moves into their 60s and 70s and begins to make their needs felt, auto manufacturers will recognize these needs and begin catering to them," Barry Skarf, M.D., PhD., an ophthalmologist at the Henry Ford Hospital in Detroit, told the conference. "The market will push the industry, because it's just too big a group to ignore."

Custom Ablation Trials Produce New Perspectives
One Finding: Low-Order Aberrations May Play a Bigger Role than Thought.

Results from the FDA clinical trials of Alcon's LADARWave CustomCornea Wavefront System were reported at the International Society of Refractive Surgery's recent meeting.

More than 200 LADARWave-assisted procedures have been performed in the trials. The results reported at the meeting reflected one new study of 21 myopic eyes conducted by Stephen Brint, M.D., clinical associate professor of ophthalmology at the Tulane University School of Medicine.

One-month post-op results from that study showed that the spherical aberration in the wavefront-treated eyes was only half as large as in the conventionally treated eyes.

According to Dr. Brint, "All current laser vision correction procedures induce significant higher-order aberrations. However, the LADARWave studies have shown significant reductions, particularly with regard to spherical aberrations induced during treatment. In the LADARWave eyes, the spherical aberration is, on average, unchanged from the pre-op level, while it approximately doubles in conventional surgeries."

Dr. Brint explained that spherical aberration has been thought of as a major cause of night vision problems, such as halos and glare, but such problems are being reported much less frequently with LADARVision, especially when it's assisted by LADARWave.

In addition, a central focus of wavefront analyses to date has been improving quality of vision by reducing higher-order aberrations. But Dr. Brint said Alcon has learned through its trials that residual low-order aberrations, even in small amounts, will mask the benefits of correcting higher-order aberrations.

"To realize the full benefit of custom ablations, the accuracy of low-order aberrations must not be underemphasized," he said. "When both high- and low-order aberrations are minimized, we will realize the potential for excellent visual acuity, accurate refractive outcomes and no post-operative symptoms."

Dr. Brint said the results of the study are consistent with overall trial results.

FDA Approves Glaucoma Drainage Device
STAAR's AquaFlow is an Alternative to Traditional Surgery.

STAAR Surgical has received approval from the FDA to market its AquaFlow collagen glaucoma drainage device for use in the treatment of open-angle glaucoma.

The company has already trained 300 U.S. ophthalmologists to use the Aqua Flow device, which was approved by the European Union in 1997 and by Health Canada earlier this year.

"FDA approval of the AquaFlow is a major milestone for our company as it opens a potential market in the United States of approximately $70 million," said David Bailey, STAAR's president and chairman.

Stephen Bylsma, M.D., of the Shepard Eye Center in Santa Maria, Calif., monitored AquaFlow testing. Dr. Bylsma said he was "impressed by the consistent results of the AquaFlow procedure, with patients returning to normal activities much faster than with traditional glaucoma surgery. This also means fewer postoperative visits."

In another regulatory action, STAAR received approval from Health Canada to market its Implantable Contact Lens (ICL) in that country. The surgically implanted ICL can be used in hyperopic eyes from +3.0 to +20.0 diopters and in myopic eyes from -6.0 to -20.0 diopters.

"This is the first approval of the ICL or any phakic implant in North America and it's come even earlier than we anticipated," said Bailey. Given the recent reduction in LASIK procedures caused by quality and vision issues in Canada, we believe STAAR is well positioned to establish the ICL as the pre-eminent alternative procedure for farsighted and nearsighted vision correction within the approved range." 

Low-Vision Bill Is Introduced
It Targets Rehabilitation.

The Medicare Vision Rehabilitation Services Act of 2001, HR 2484, has been introduced in the U.S. House of Representatives. The bill, introduced by Reps. Michael Capuano (D-Mass.) and Mark Foley (R-Fla.), is intended to fill gaps in coverage for Medicare beneficiaries who have low vision caused by a variety of medical conditions.

The bill essentially provides for national coverage of vision rehabilitation therapy conducted in a doctor's office, clinic or vision rehabilitation center, by either a physician or a directly supervised staff member.

The American Academy of Ophthalmology (AAO), which is backing the bill, says the legislation is intended to serve a critical need for millions of seniors whose impairment isn't correctable by conventional refraction, medication or surgery. The number of people experiencing low-vision problems is increasing as the population ages.

Medicare currently covers low-vision evaluations conducted by ophthalmologists, but in many states these patients still lack coverage for prescribed therapy. Only 26 states now cover vision rehabilitation services, through either written or unwritten local Medicare carrier policies.

"It's important to note that this bill isn't proposing a new benefit," said Catherine Cohen, vice president for governmental affairs for the AAO. "Rather, it standardizes coverage so that all Medicare patients who need vision rehabilitation services can have equal access to them regardless of where in the United States they may live."

Preliminary 2002 Fee Schedule Is Published
New Codes Will Cover Glaucoma Screening.

The chart below shows the proposed 2002 national average Medicare reimbursements for selected ophthalmology codes, including eye exams, cataract surgery and the new glaucoma screening benefits, as well as average reimbursement rates for this year and last year.

The proposed 2002 calculations use the 2001 conversion factor. Final reimbursement rates will be based on an updated 2002 conversion factor that will be published by the Centers for Medicare and Medicaid Services (formerly HCFA) later this year.

Note: The proposed 2002 Medicare Fee Schedule also includes proposed payment and coverage criteria for glaucoma screening benefits that were passed by Congress last year.

Photo courtesy of the American Academy of Ophthalmology, the Eyemd Association

Dr. Oliver H. Dabezies Dies
His Distinguished Career Was Multifaceted.

Oliver H. Dabezies Jr., M.D., an internationally known leader, educator and author in the field of ophthalmology, died of cancer this summer in New Orleans. He was 71.

Dr. Dabezies, a New Orleans native, was a clinical professor of ophthalmology at Tulane Medical School in New Orleans. He was also a past member of the board of trustees of the American Academy of Ophthalmology, served as secretary of the American Medical Association's (AMA) ophthalmology section and had been president of the New Orleans Academy of Ophthalmology and the Southern Eye Bank. He also wrote a book, History of Ophthalmology in the American Medical Association, which is today considered one of the definitive works in ophthalmic history.

Dr. Dabezies' interest in contact lenses led him to found and lead the Contact Lens Association of Ophthalmologists, whose textbook on contact lenses he also authored. He also founded the International Contact Lens Society of America and was head of an American National Standards Institute committee that developed the groundbreaking FDA standard for preventing injury from contaminated contact lens-care products.

"Oliver's behavior and actions were always based on what he perceived to be the best for medicine and ophthalmology. His values and motives are an example for all of medicine and humanity," said Dr. Dabezies' friend and colleague, Bruce E. Spivey, M.D. "His personal qualities of loyalty and individual concern were exceptional."

Dr. Dabezies was the recipient of numerous awards and honors over the course of his career and was to receive the AMA's Howe Medal in Ophthalmology at the organization's annual meeting this year.

IN THE NEWS

Refractec trials. The FDA has approved a Phase III clinical trial to evaluate Refractec's radiofrequency energy treatment for presbyopia. The company's ViewPoint System is designed to reshape the cornea through a procedure known as conductive keratoplasty.

Continuous wear. An FDA advisory panel committee unanimously recommended that CIBA Vision's Focus Night and Day soft contact lenses be approved for 30-day continuous wear. CIBA Vision says the lenses are made of a material that allows more oxygen to reach the eye and reported no infections during recent clinical trials.

Settlement. The Vistakon division of Johnson & Johnson Vision Care has settled a class action suit alleging misleading marketing of 1-Day Acuvue and Acuvue contact lenses. The suit charged that Vistakon created the false impression among consumers that the less expensive 1-Day Acuvue lens was different than the Acuvue lens and required a shorter wear schedule. In fact, the two lenses are medically suitable for the same wear schedule. Johnson & Johnson and Vistakon deny these allegations. The settlement includes cash, product purchase credits and refunds to be used for eye examinations.

Viscoelastic approved. Anika Therapeutics has received FDA pre-market approval for its Shellgel viscoelastic product, which protects eye tissue and maintains eye shape during ophthalmic surgery.

Appointed. Jake Vander Zanden has been named director of global marketing, Eye Care Pharmaceuticals, by Allergan, Inc. Vander Zanden's responsibilities will include directing the worldwide launch of bimatoprost 0.03% (Lumigan) glaucoma medication. Lumigan has recorded worldwide sales of $9.6 million since its recent introduction.

Expanded usage. Health Canada has approved the use of verteporfin for injection (Visudyne) therapy for the treatment of classic subfoveal choroidal neovascularization (CNV) due to pathologic myopia. Health Canada had earlier approved Visudyne for the treatment of CNV due to age-related macular degeneration.

Xalatan growth. Pharmacia Corp. said sales of its market-leading glaucoma medication, latanoprost 0.005% (Xalatan) increased to $171 million in the June quarter, representing 14% growth from the comparable year-ago period.

Acquisition. Vision Pharmaceuticals, which markets Viva-Drops for dry eye through ophthalmologists, optometrists and retail outlets, has been acquired by Corneal Sciences Corp., a privately owned pharmaceuticals company.

Dry eye. Novartis Ophthalmics has a new addition to its GenTeal line of dry eye treatments. GenTeal Mild is intended for use by individuals who suffer mild symptoms of dry eye. The new product joins GenTeal original formula for moderate dry eye and GenTeal Gel for severe dry eye.

Visudyne sales. QLT Inc., the co-developer of Visudyne, said worldwide sales of the drug grew to $86.7 million in the three months ending June 30, a 17% increase over the first 3 months of the year.

REFRACTIVE SURGERY UPDATE

Pro-LASIK group. In an effort to counteract a flurry of recent negative press reports that have focused on the potential dangers of LASIK surgery, leading laser vision correction companies and equipment manufacturers have formed the Refractive Surgery Industry Association. TLC Laser Eye Centers and LCA-Vision are among the charter members of the association, which intends to fund a campaign to address what it calls misinformation concerning the safety and effectiveness of laser vision procedures. The group will also share data on industry advances, procedure volume and patient outcomes.

Web site in Spanish. The LASIK Institute has launched a Spanish language Web site that provides basic patient information to those considering having the vision correction procedure. The easy-to-navigate site can be accessed at www.lasikinstitute.org.

Patent dispute. A bitter patent dispute over microkeratome blades between Bausch & Lomb and its much smaller rival, Oasis Medical, Inc., appears headed for trial after a judge in U.S. District Court refused to enter a summary judgment in favor of Oasis. However, the court did raise questions concerning the validity of B&L's patent for its Hansatome microkeratome blade assembly.

ClearVision acquired. Laser Vision Centers, Inc. (LVCI), a major provider of excimer lasers and support services to refractive surgeons, has acquired ClearVision Laser Centers, Inc. of Lakewood, Colo. ClearVision operates fixed and mobile excimer lasers used in refractive eye surgery, with a strong presence in Colorado, Utah and the Pacific Northwest. With ClearVision, LVCI will operate 125 lasers, providing access to 925 surgeons in 47 states.