2001 Ophthalmology's Year In Review
Its positives and negatives will shape the years to come.
By Jerry Helzner, Associate Editor

As 2001 began, plenty of patients were eager to have refractive surgery, but discounters were exerting downward pressure on pricing. As the year drew to a close, the situation had literally reversed. The most aggressive discounters had disappeared, but so had the previous abundance of patients.

LASIK patients became more scarce as the year progressed, primarily due to the slowing economy, negative news stories, and the loss of consumer confidence following the Sept. 11 terrorist attacks. When the final figures are tallied for the year, most industry analysts say the number of laser vision correction procedures performed in the United States in 2001 probably won't even match the approximately 1.4 million of last year. Estimates for total procedures now range from about 1.26 million on the low side to approximately 1.5 million from the most optimistic forecasters.

"It looks like 2001 will go down as both the boom and the bust year for laser vision correction surgery," says John Pinto, president of J. Pinto & Associates, Inc., an ophthalmic practice management consulting firm. "With the war jitters, rising unemployment and tapped-out borrowing power, the average LASIK candidate will now be on the sidelines for at least the next year. The silver lining to this dark cloud is that a significant demand for surgery will slowly build up, so that when business returns it should do so with a roar."

The corporate-driven chaos that characterized the LASIK marketplace during much of 2000 quieted down considerably in 2001 as several laser vision correction chains, including high-profile discounter Lasik Vision, filed for bankruptcy and others merged. The largest merger was announced in late summer when TLC Laser Eye Centers and Laser Vision Centers Inc., which together account for more than 20% of the laser vision correction procedures performed in North America, agreed to combine.

What we were talking about

Meanwhile, we moved closer to the promise of custom ablation, as laser systems incorporating wavefront technology entered U.S. clinical trials. According to a recent industry report from Goldman Sachs, more than 95% of refractive surgeons say they expect to perform custom ablation once clinical trials are completed in the United States and complete platforms for performing the procedure are approved by the FDA. About 14% of the refractive surgeons surveyed by Goldman Sachs have already shown their confidence in the future of the technology by purchasing wavefront components, which can be used as stand-alone diagnostic tools.

And while LASIK caught the attention of the public -- and the media -- in 2001, this article will describe how numerous other events and developments made this a year that will go down as one of the more memorable in the history of the profession. Worth noting were:

• victories and disappointments in the legislative and regulatory arenas
• advances in pharmaceuticals and treatments
• significant gains in technology
• a strengthening trend toward the operation of more practice-owned ambulatory surgery centers (ASCs)
• problems for some ophthalmology-related businesses
• the ophthalmology community's timely and valuable assistance in providing eye care to victims and rescue workers in the aftermath of the World Trade Center tragedy
• the death of ophthalmology pioneers. (See "We Say Farewell".)

Overall, a positive year

"Overall, 2001 has been an exceptionally good year for ophthalmology, says George W. Blankenship, M.D., president of the American Academy of Ophthalmology (AAO). "In fact, our annual survey of AAO members showed by far the most positive responses we've seen in years. Many more of our members are now feeling better about the future of their own practices, and about four out of five are happy with their decision to become ophthalmologists."

I. Howard Fine, M.D., president of the American Society of Cataract and Refractive Surgery (ASCRS), concurs with that positive assessment and takes it a step further.

"We're now in the golden age of ophthalmology. We've never had so much to offer patients," says Dr. Fine. "This year we've seen spectacular advances in phacoemulsification (See "Strides in Phacoemulsification," on page 31.) and the introduction of new types of IOLs (See "IOL Technology Advances," on page 32.) that have vastly improved the safety and efficacy of cataract surgery. And we've had wonderful results with promising new concepts, such as accommodative and phakic IOLs, that are currently in clinical trials."

Some of the developments that made 2001 a landmark year for ophthalmology:

Success in regulatory areas. Accomplishments for the year include higher fees for complex cataract surgery and eye exams, and exemption from Stark II prohibitions (allowing self referrals for post-cataract eyeglasses and contact lenses). New federal regulations governing patients' privacy were also announced, but some provisions that physician organizations consider burdensome could still be revised before they go into effect in 2003.

Progress in the legislative arena. A bill providing for regular glaucoma detection screening for at-risk individuals was signed into law in 2001. Congress also has agreed to significantly increase funding for the National Eye Institute. Proposed legislation offering regulatory relief to Medicare providers who are charged with receiving overpayments -- reversing "guilty until proven innocent" enforcement -- has garnered bipartisan support in Congress.

Controversial bills to regulate co-management died in Florida and Missouri, leaving the joint AAO/ASCRS guidelines on co-management as the operative nationwide standard for such arrangements. And after a 7-year struggle, a Patients' Bill of Rights was on the verge of becoming law when the Sept. 11 terrorist attacks sidetracked the work of Congress. Slightly different versions of the legislation were passed by the House of Representatives and the Senate. These versions will have to be reconciled, either in conference committee or through informal negotiation between House and Senate leaders.

Improved pharmaceuticals and treatments. Ophthalmologists surveyed by Ophthalmology Management for this article cited the wider array of effective glaucoma medications now available, including several introduced in 2001. Launches this year include bimatoprost ophthalmic solution 0.03% (Lumigan), travoprost ophthalmic solution 0.004% (Travatan) and brimonidine tartrate ophthalmic solution 0.15% (Alphagan P).

In the area of glaucoma surgery, STAAR Surgical's long-awaited AquaFlow collagen glaucoma drainage device was also approved this year. Implanted during a nonpenetrating surgical procedure, the AquaFlow promises to reduce intraocular pressure with few of the complications often associated with traditional glaucoma surgery. On a broader scale, the whole area of nonpenetrating filtration surgery saw renewed interest in 2001, as leading glaucoma surgeons recognized the advantages of a "no-bleb" procedure that eliminates the potential for bleb-related complications.

The year also saw increased acceptance of selective laser trabeculoplasty (SLT) as an evolutionary improvement over argon laser trabeculoplasty (ALT) in treating open-angle glaucoma. Surgeons using the lower-energy, shorter pulse SLT modality offered by the Selecta 7000 laser report that the treatment can achieve results similar to ALT in lowering IOP and improving the visual field, but without the thermal scarring and collateral damage to the trabecular meshwork that usually results from ALT treatment.

In the retinal area, approval for the use of Visudyne was extended to additional forms of choroidal neovascularization (CNV) in 2001, and the publication of the long-awaited Age-Related Eye Disease Study showed encouraging data indicating that vitamins and supplements can help in preventing the progression of AMD. Another study conducted by researchers at The Schepens Eye Research Institute concluded that early and regular incorporation of aspirin into the treatment regimen of diabetic patients can help prevent diabetic retinopathy.

In addition, transpupillary thermotherapy (TTT) gained credibility as a treatment for wet AMD when Noridian Mutual Insurance, a Medicare Part B carrier for 11 Western and Midwestern states, said it would cover TTT procedures administered to patients with CNV secondary to wet AMD.

And in the areas of dry eye and ocular allergy, the pace of research is picking up, and important breakthroughs appear to be on the horizon.

Advances in refractive surgery technology. Several companies, including Bausch & Lomb, Nidek and Alcon, introduced new eye-mapping and measuring devices that employ wavefront technology. These components are designed to be integrated into complete custom ablation systems, which are still in clinical trials and awaiting FDA approval.

The Pulsion FS femtosecond laser, which received FDA approval for cutting the flap during refractive surgery, was well received by a number of prominent surgeons. IntraLase says the laser permits refractive surgeons to cut a flap more accurately and with less risk of complications than a microkeratome.

The year has also seen an increase in interest in laser epithelial keratomileusis (LASEK) (See "LASEK Gains Converts," on page 34.) as a refractive surgery modality with fewer risks.

Emerging treatments for presbyopia. In 2001, a variety of efforts were focused on finding viable treatments for presbyopia. The year saw wider acceptance of Prelex, which employs a multifocal IOL to correct near, distance and intermediate vision. Other treatments currently being investigated include scleral expansion bands, conductive keratoplasty using radio frequency technology, accommodative IOLs and a scleral ablation procedure using SurgiLight's OptiVision YAG laser that's achieved good results in overseas studies.

Expanded research efforts. Several development-stage treatments based on gene therapy, including those aimed at dry eye, AMD and forms of retinitis pigmentosa, also moved ahead in 2001. Advances were also reported in harvesting stem cells for limbal stem cell transplantation, a procedure that has achieved some success in reversing blindness caused by chemical damage or rare eye disorders.

More practice-owned ASCs. An easier regulatory climate, a narrowing of the reimbursement gap vs. hospital-based surgery, and growing demand for ophthalmic services by 55+ baby boomers are encouraging practices to build or share ASCs. This trend strengthened in 2001 as more practices recognized the real benefits of ASC ownership.

Ongoing concerns

But at yearend, some concerns remain. Many practices are still grappling with basic issues, such as staffing, paperwork reduction and finding effective ways to use the Internet. Some practices report continuing problems in attracting qualified ophthalmic staff, or even in finding good entry-level employees. Other practices are struggling to upgrade computer systems so they can participate in electronic claims processing. And still others haven't yet harnessed the power of the Internet as a vehicle to communicate with patients, market their services and share information with other medical professionals

At the national level, the 2002 Medicare Fee Schedule, released on Nov. 1, includes an across-the-board 5.4% reduction in physician payments, based on a payment formula that's tied to the growth of the Gross Domestic Product. The AAO, ASCRS and the American Medical Association are working with members of Congress to pass legislation that will change a formula that the physicians' organizations say has no relation to the cost of providing medical services.

In addition, the slowing economy and stock market meltdown affected many ophthalmology-related businesses, raising fears that capital for ophthalmic innovation may not be easily available. One fledgling company, KeraVision, the developer of Intacs inserts as a treatment for myopia, went bankrupt and sold its technology in 2001.

Even the largest players weren't immune. Bausch & Lomb saw its CEO resign in late summer after a series of disappointing earnings reports. The company in November named its former president, Ronald Zarrella, as its new chairman and CEO.

A long-range concern is that ophthalmology, which has become primarily an office-based and outpatient specialty, may slowly be losing its connection to the hospitals that serve the larger medical community. The president of the AAO, Dr. Blankenship, says ophthalmologists will have to be proactive in maintaining their ties to the general practice of medicine.

It's been an eventful year

Almost everyone surveyed for this article agreed that, on balance, ophthalmology experienced more positives than negatives in 2001. However, no review of the year would be complete without a mention of the ophthalmology community's response to the terrorist attacks of Sept. 11.

On that day, eye doctors from throughout the New York City metropolitan area rushed to hospitals near "ground zero" to treat World Trade Center victims and rescue workers. For the next 3 days, volunteer ophthalmologists worked at eyecare stations quickly set up near ground zero, treating rescue workers for eye irritation and corneal abrasion. The supplies necessary to operate these stations flooded in from hospitals, private practices and virtually every major eyecare company.

In an eventful year for ophthalmology, it's somewhat fitting that ophthalmologists played a prominent role in the single event that will define 2001 in history.

2001 We Say Farewell

The world of ophthalmology lost several of its pioneers in 2001. Sir Harold Ridley, M.D. Photo courtesy of David J. Apple, M.D. Sir Harold Ridley, M.D., inventor of the IOL, died at the age of 94 in May at his home in Salisbury, England. Dr. Ridley introduced the IOL in 1949, implanting a plastic lens in the eye of a male patient who had undergone cataract surgery 2 months earlier. However, it took many years for the IOL to gain widespread acceptance in the ophthalmology community. Following Dr. Ridley in death was one of his associates, D. Peter Choyce, FRCS, who helped perfect and popularize the IOL by developing the Choyce Mark IOL in the 1950s. Dr. Ridley credited Dr. Choyce with advancing IOL technology just when the device was about to be abandoned by the ophthalmology establishment. Dr. Choyce was 82 when he died in England in August. Oliver H. Dabezies Jr., M.D.. Photo courtesy of the AAO An American ophthalmology pioneer, Oliver H. Dabezies Jr., M.D., who made his mark as an author, educator and leader, died in New Orleans in June. He was 71. Dr. Dabezies was a founder of the Contact Lens Association of Ophthalmologists and wrote a textbook on contact lenses. He also wrote a book, "History of Ophthalmology in the American Medical Association," which is considered a definitive work in ophthalmic history. The year also marked the passing of Andrew F. Pollet, who served as chairman and CEO of STAAR Surgical Company. Pollet's last months with STAAR were marked by disappointing financial results and attempts by a shareholder group to gain a larger voice within the company