BB&T Contributing Editor
and AMANDA PEDERSEN
ATLANTA – The annual meeting of the American Academy of Ophthalmology (AAO; San Francisco), largest annual gathering of eye physicians in the world, took place here in November. The gloomy economic environment has had a very negative impact on the ophthalmic surgery community, mostly so for domestic surgeons whose practices are heavily keyed to discretionary spending, primarily consumer-paid refractive surgery procedures such as LASIK. Some areas of the U.S., especially the east and west coasts, have been reporting that LASIK volume is down 40% to 50% compared to last year.
In a talk at the Refractive Surgery 2008 Subspecialty Day, aptly titled "Current Trends in Refractive Surgery," Dave Harmon, president of MarketScope (St. Louis), discussed the dismal trend in LASIK procedures in 2008. He indicated that while first-quarter procedures were down 11%, they plunged 24% in 2Q08 and 35% in 3Q08. Moreover, he expects procedures to further plummet 41% in 4Q08.
Thus, for the full year Harmon predicted that total domestic LASIK procedures would decrease 26% vs. 2007.
His 2009 forecast also is bleak, with full-year LASIK procedures expected to decrease another 7% to about 965,000 vs. 1.032 million in 2008. In an interview with, Harmon told Medical Device Daily that his 2009 prognostication could well prove to be optimistic, as it is predicated upon a recovery in consumer sentiment in 2H09.
Despite this clearly rugged outer environment, this year's AAO was very well-attended, with packed lecture halls and the exhibit area showing a steady flow of physicians and industry representatives.
One of the industry leaders, Bausch & Lomb (B&L; Rochester, New York) held a media event to provide an update of its activities. In late October 2007, B&L was acquired by the global private equity firm Warburg Pincus (New York) for a total purchase price of roughly $4.5 billion, including the assumption of about $830 million of debt. With the Warburg purchase, B&L transitioned from being a public company to a private one.
Jerry Ostrov, who joined B&L in January 2008 as chairman/CEO, told attendees that B&L is "focused on the long term" and while the current environment is choppy, he is entirely comfortable with the company's situation.
"Our financial position is solid and our revenue and earnings are steady or modestly increasing," he said.
An example of where B&L is performing well is in the presbyopic intraocular lens (P-IOL) space, where it is now approaching market leadership. The acquisition of privately-owned Eyeonics (Aliso Viejo, California) in January has been a pivotal strategic move for B&L, which prior to this deal did not participate in this high-growth, lucrative market segment.
In 2007, Eyeonics showed meteoric growth, with revenue of $34 million doubling the previous year. Growth has continued at a very impressive pace in 2008, with revenue once again expected to at least double the prior year, reaching at least $70 million.
The FDA's approval in June of the company's third-generation P-IOL, trade-named Crystalens HD, has been a key contributor in 2008. This lens is by far the company's best P-IOL model, providing excellent vision for most patients in the near (reading), intermediate (computer distance) and far distance fields. Its earlier models often did not provide crisp reading benefits in some patients.
According to MarketScope, Eyeonics' share has reached about 40% of the P-IOL domestic market at the end of 3Q08, up from about 26% at the close of 2007, challenging industry leader Alcon (Fort Worth, Texas). The latter's share has declined to the mid-40s in the latest quarter.
Jay Pepose, MD, director of the Pepose Vision Institute (St. Louis) told attendees that the Crystalens represents a "paradigm shift" in the treatment of presbyopia and that its ability to mimic the accommodative ability of the natural lens clearly distinguishes it from other presbyopic IOLs.
"I think that accommodating IOLs represent the wave of the future and that this is the best product in its class," Pepose said.
Earlier this year, Eyeonics began to test a direct to consumer (DTC) marketing campaign in three metropolitan areas (St. Louis, Dallas and Raleigh, North Carolina) in a bid to grow the overall P-IOL market.
According to Ostrov, this DTC program is an effort "to grow our markets, not steal market share." The DTC program most likely will be broadened across the country in 2009.
Another area where B&L management is optimistic is in conventional post-cataract IOLs, where it has an excellent new product. In mid-September, the FDA approved the Akreos AO, a high-water-content acrylic, single-piece lens. It features a unique four-haptic design and aspheric optics designed to be aberration-free. Importantly, it is capable of being implanted in a very tiny, sub-2 millimeter incision.
Robert Weinstock, MD, of the Weinstock Laser Eye Center (Largo, Florida), has been one of the first users of this lens and although he has performed relatively few cases so far, Weinstock said, "I have found this lens to be remarkable. It has a very smooth delivery, fixates within the eye very easily and has beautiful centration. I am extremely impressed."
A next-generation Akreos model, the M160, will further enhance B&L's competitive position when it receives marketing clearance in the U.S. In April, this lens received the gold award at the Medical Design Excellence Awards, a leading medical awards program for the medical technology industry.
The ability of Akreos to be implanted in a sub-2 millimeter incision is especially significant because it can be implanted after removing the cataract with B&L's Stellaris micro-incision phaco-emulsification system.
Elizabeth Davis, MD, director of the Minnesota Eye Laser and Surgery Center (Minneapolis), told attendees that this device offers her the safest, fastest and easiest method to remove a cataract. Its tiny incision reduces the likelihood of surgically-induced astigmatism and infection and facilitates the use of IOLs that can be folded and inserted in a very small opening.
She said that "Stellaris is an exceptional system for all surgeons."
Closing the meeting, Ostrov made it clear that the "new" Bausch & Lomb intends to compete vigorously and wants to be "either No. 1 or No. 2 in every market it competes in."
Both STAAR Surgical (Monrovia, California) and Alcon (Fort Worth, Texas) also held informational meetings with the financial community during AAO.
Since its founding in the early 1980s, STAAR has been a company whose steady flow of new and outstanding products has not translated into profitable and consistent financial results. One result has been that the company has been forced several times to raise dilutive equity capital from its shareholders to sustain its operations.
Upon joining STAAR just over a year ago, CEO Barry Caldwell embarked on a program to wean STAAR from outside financing and achieve a solid financial footing. Five initiatives were established to achieve this goal:
1) Reduce the quarterly cash burn.
2) Improve gross margins.
3) Maintain continued strong international growth.
4) Successfully integrate the Canon business acquired in January, with annual revenue to reach or exceed $12 million.
5) Stimulate the growth of the U.S. refractive business.
In 2008 to date, the company is performing well relative to these targets, especially with its gross margins expanding impressively from 49.7% in 3Q07 to 57.7% in 3Q08. Combined with stringent expense controls, STAAR has been able to slash its operating loss from $3.6 million last year to $1.4 million this year, which in turn lowered the cash burn significantly.
Caldwell told meeting attendees that "we are pleased with our progress and our goal in 2009 is to be profitable." Wall Street analysts who follow STAAR think the company can become profitable and generate cash within the next few quarters.
A key driver to STAAR's recent financial progress and anticipated future growth success rests with the Visian ICL. This phakic, refractive intraocular lens (IOL), made from STAAR''s proprietary collamer material, has shown tremendous growth, with global revenue for the first nine months of 2008 surging 52% over last year. Conversely, according to MarketScope (St. Louis), domestic LASIK procedures are forecasted to decline 26% in 2008.
This stellar performance has been fueled by excellent domestic media exposure, such as the Today show, a new direct sales and marketing team and an improved website. To a lesser extent, demand has benefited from negative FDA-related publicity for LASIK that occurred in the spring.
Outside the U.S., approval in China, the world's second-largest refractive market with about 650,000 refractive procedures, has boosted the company's international revenue. The fastest-growing portion of Visian revenues is coming from the toric version of the ICL (T-ICL), which has grown 70% this year and now accounts for nearly half of all Visian international revenue.
STAAR does not have a domestic T-ICL approval as yet, having incurred FDA-related challenges in the past couple of years. Based upon a recent re-audit of the data, which appear to validate its accuracy and communication with FDA, it appears that an approval could come sometime in 2009. This approval would be a boon for STAAR's domestic Visian revenue.
Rob Rivera, MD, of the Barnet, Dulaney & Perkins Eye Center (Phoenix), has been implanting the Visian ICL since 1997, when he became a clinical investigator. He may now be the largest Visian implanter in the U.S. and he certainly is one of the most enthusiastic, based on comments at the analysts meeting.
"I believe that the Visian provides far superior visual outcomes for my patients than does LASIK," he said. Rivera also said that he is so confident in the safety of the Visian that he has no qualms about performing a bi-lateral procedure.
He also extolled the clarity of the vision his patients are receiving. "The Visian ICL gives my patients 'high definition' quality vision. The result is that the vast majority are extremely pleased with the outcome."
Caldwell noted that a recent survey of Visian patients revealed that 98% of them were either "extremely satisfied or very satisfied" with their outcome. This compares favorably to the 95% of LASIK patients who reported that they were "satisfied" with their results.
Rivera said he is eagerly anticipating the potential availability of the T-ICL in the next several months. It is common for high myopes to also have astigmatism that needs correction and Rivera said the T-ICL is "the best single procedure in terms of vision quality" for these patients.
Indicative of the need for this product, he told attendees that his practice has a backlog of 800 patients awaiting the approval of the T-ICL.
Whereas STAAR has struggled financially as a niche player in ophthalmic anterior segment surgery, broad-based Alcon has been hugely successful, growing rapidly and enjoying excellent profitability for many years.
At its traditional analyst meeting at the AAO, Alcon CEO Carey Rayment said the company has a long history of excellent execution and financial performance and that this should continue as "solid long term fundamentals underlie our markets and our business."
Rayment reiterated that Alcon's long-term business model projects 8% to 10% organic sales growth and positive margin evolution.
"These fundamentals remain intact," he said, although in its last investor conference call after 3Q08 results were announced and again at this meeting, the company guided 2009 revenue expectations considerably lower. Two key factors are the expected impact of generic competition to TobraDex, a widely used antibiotic/steroid combination which is coming off patent early next year, and the impact from the economy.
In addition, the company now expects unfavorable foreign currency fluctuations to reduce reported sales in 2009 by 5% to 6%, implying that reported top-line growth for 2009 will be a very modest 2% to 3%. By comparison, global revenue growth in 2007 was 14% higher than 2006 and expected 2008 revenue will be up about 12% to 13% over 2007.
Alcon has a deep pipeline of new products, some of which will be rolled out in the coming months. In particular, the company expects a significant contribution from the ReSTOR aspheric +3.0 multi-focal lens.
Kevin Buehler, chief marketing officer, said that in comparison to its current +4.0 Acrysof lens, this new product offers patient better reading and intermediate distance visual acuity.
"Our studies show that there is higher rate of patient satisfaction and spectacle independence," Buehler remarked.
Alcon filed a PMA for this lens in 2Q08, implying that approval could come in the next few months. Upon approval, it will be marketed against Bausch & Lomb's very successful Crystalens HD accommodating IOL.
The company also is entering the phakic IOL market in Europe, having recently received a CE-mark designation. It will compete head-to-head against STAAR, but will not be able to offer a toric version.
In the U.S., the company is planning to meet with the FDA in early 2009, hoping to accelerate a PMA filing before the mandated three-year follow-up is complete. Final FDA approval appears possible in 2010.
McLeod: 'No one untouched' by downturn
One thing is certain, according to Stephen McLeod, MD, professor and chairman of the department of ophthalmology at the University of California, San Francisco: "No one has been untouched by the decreased activity of laser-based refractive surgery."
That observation was one of several McLeod shared with the investment community and members of the media during a post-AAO ophthalmology webcast hosted by Joanne Wuensch, a med-tech analyst for BMO Capital Markets' Equity Research Group.
McLeod serves as a consultant to the Ophthalmic Devices Panel of the FDA, is on the editorial board of the American Medical Association's (Chicago) journal for ophthalmology research, Archives of Ophthalmology, and is chair of the Preferred Practice Pattern panel on refractive surgery for the AAO.
McLeod said a not-so-light moment for him during the meeting was when Robert Maloney, who is the exclusive LASIK surgeon for ABC's Extreme Makeover and one of the most well-known refractive surgeons in Los Angeles, introduced himself as 'Robert Maloney, former refractive surgeon.'
"Everybody's taking a hit on the laser refractive side," McLeod said.
His expertise is in the area of refractive surgery and corneal disease. In the field of refractive surgery, his expertise includes the diagnosis and surgical management of refractive error through laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK), while in the field of cornea and external disease his expertise includes conjunctival and anterior segment disorders, corneal infection, inflammation and opacification, ocular surface tumors, trauma, adult cataract and intraocular lens complications as well as infantile developmental corneal anomalies and pediatric cataract.
While elective refractive surgery is clearly taking a hit, McLeod told webcast listeners that the premium intraocular lens (IOL) market has actually seen quite a bit of resilience. He believes the reason for that is the difference between someone who wants to have refractive surgery as an alternative to wearing glasses or contacts but can easily hold off on getting LASIK until the market recovers and somebody who has to have cataract surgery because they have a compromise in visual function "and they're essentially making a decision about the [quality of vision] that they assume they're going to have for the rest of their life."
"So it's one thing to scrimp or to hold off on the purchase for elective refractive surgery, it's quite a different thing to say you're going to save a few hundred or a few thousand dollars at this point in time but forever forgo the ability to do a wide array of functions without glasses," he said. "So I think that there is a very good reason for the lack of sensitivity or the lesser sensitivity of the premium IOL market to the pressures of the day."
When asked to compare the current downturn in refractive surgery to the downturn McLeod experienced in his practice in 2001, McLeod said that the biggest difference is that in 2001 there were still a lot of people across all age ranges who had thought about refractive surgery and decided that was the right time. "Even though there was a slowdown, I think to some extent it was buffered a bit. I'm not seeing the same kind of buffer now," he replied.
Looking ahead, the 2009 refractive surgery market looks "dreadful," McLeod noted, but quickly added, "I'm a pessimist." He said he believes that whatever is happening in the market place will be reflected in the laser-based refractive surgery sector because it is discretionary spending.
Digging deeper into trends of the refractive surgery sector, McLeod said that looking at the distribution of device popularity over the last couple of years what seems to be happening is that while the total market is holding steady, the proportion of the market held by multifocal devices, sold currently by Alcon (Fort Worth, Texas) and Advanced Medical Optics (Santa Ana, California), seems to be slipping a bit and is being picked up by single accommodative devices (Medical Device Daily, Nov. 11, 2008).
He said it is probably because multi-focal lenses do come with some degree of downsides such as glare or halo where as the main downside of single accommodative devices is that if it doesn't work the patient simply doesn't get to see as well up close as they had hoped.
When asked if there was any new technology presented at the AAO meeting that McLeod thought was particularly neat or that he thinks the ophthalmology community as a whole found particularly interesting, his answer was, essentially, no.
"At present there's more commitment to pulling the devices that seem to have some promise through the pipeline, but no, I actually didn't see anything that's about to break into the market that really represents a paradigm shift."
One area McLeod said would be interesting to watch, however, is the relationship between cornea crosslinking and corneal stability and the risk for keratoconus. He said there is a fairly large group of patients who don't qualify for LASIK surgery because of a thin or elastic cornea. In his own practice, McLeod says he ends up disappointing as many as one in five patients who come in wanting LASIK surgery because by telling them it's not safe for them to have the surgery.
It turns out, he said, that there are new techniques being developed which have to do with making the cornea stiffer, which could open up the market of refractive surgery to those patients.
The AAO meeting drew about 22,000 attendees. Attendance at the Subspecialty Day events also were strong, AAO said, totaling more than 6,200.
The keynote address for the meeting was delivered by Harvey Fineberg, MD, PhD, president of the Institute of Medicine (Washington). In his address, "Seeing the Future of Health Care," Fineberg said America is facing a demographic transition that will significantly increase the demand for care, particularly ophthalmic care.
"Ophthalmology is in the crosshairs of this demographic transition and the demand for services and cost of healthcare in the U.S.," he said. The key, he said, is to "relentlessly focus on increasing the value of what we do for patients – a combination of improving performance and outcomes and decreasing costs. Getting more for every dollar spent."
Platform for new products
Carl Zeiss Meditec (Jena, Germany/Dublin, California), a maker of ophthalmic systems including IOLs and disposable lenses, reported additions to its product offerings at the meeting.
The new OPMI Lumera i Surgical Microscope offers the same Stereo Coaxial Illumination (SCI) as the OPMI Lumera, introduced a year ago, with the addition of new integrated workflow efficiencies designed specifically for the operating room environment. These new features include a touch-screen control panel, integrated camera control and an ergonomic foot pedal.
The new Visulas Trion Combi System is, according to the company, the world's first multi-color photocoagulator paired with a photodisruptor to offer the complete treatment solution for the retina practice. Using yellow, red and green wavelengths, surgeons can perform a variety of retinal procedures with the added capability to perform iritdotomies with the companion YAG laser.
"Our new innovations at this meeting are designed to provide the clinician with better diagnostic and treatment options while streamlining efficiency in the practice," said President/CEO Michael Kaschke. "Our goal is to be the partner that our customers can depend on today and for years to come, by providing technologies that stand the test of time and programs that address their unique needs and practice environments."
In addition to the new products, Carl Zeiss Meditec showcased several recent innovations for its Optical Coherence Tomography (OCT) and IOLMaster Biometry systems. The new advancements are designed to improve the scalability and clinical applications of these products.
Cirrus HD-OCT Review Software brings the capabilities of Cirrus HD-OCT analysis to the exam lane, the company said. To streamline office workflow, this new software enables dynamic viewing of images and analyses at a remote location, such as a laptop or personal computer.
IOLMaster Advanced Technology Software Version 5 offers a new composite axial length algorithm that increases the number of patients that can be measured for intraocular lenses (IOLs), including those suffering from dense, opaque cataracts and those who have undergone hyperopic laser vision correction.
Key refractive solutions featured at this year's meeting included the VisuMax Femtosecond System and MEL 80 for laser vision correction, as well as the Acri.LISAtoric multifocal intraocular lenses for refractive cataract surgery.
Acri.LISAtoric, which Carl Zeiss said is the world's only multifocal toric MICS IOL, was launched at ESCRS 2008 and debuted in the U.S. for the first time at the AAO meeting. An international multi-center study is currently under way at some 20 centers in the UK, Europe and Asia.
Lumenis (Yokneam, Israel/Santa Clara, California) introduced four new ophthalmic lasers and delivery devices:
• Selecta Trio, which the company calls "the pinnacle product in the Selecta family," offering retinal, cataract and advanced glaucoma therapies in a single platform. Luminis said the unit's integrated design, enhanced optics and advanced laser cavity "make the Trio one of the highest-performing laser products in the market – offering maximum flexibility with minimum footprint."
• Selecta Duet, which Lumenis said "represents the industry's most advanced anterior-segment laser, combining the advantages of YAG photodisruption capabilities along with the innovative Selective Laser Trabeculoplasty (SLT) technology." The company cited the system's "fully integrated design, enhanced optics and advanced laser cavity." It said the Duet also is the only upgradeable SLT and YAG combination laser currently available on the market.
• Novus Spectra Dual-Port, which Lumenis calls "an innovative photocoagulator with an extensive set of features that deliver power and reliability with proprietary advancements in diode-pumped solid-state technology." It said an active resonator temperature control ensures stable beam output and system reliability, adding that the system is "compatible with a wide array of delivery devices."
• LumeProbe Endo Photocoagulation Laser Probes, which the company says is "a comprehensive and robust set of premium ophthalmic endo photocoagulation laser probes for OR usage." Lumenis said the LumeProbe product family was "designed to deliver laser energy in the safest and most efficient manner, guaranteeing optimal clinical outcome for all relevant viteroretinal indications."
Dov Ofer, Lumenis president/CEO, said, "Our new laser delivery devices are specifically designed to provide superior performance, as well as improve physician comfort during procedures."
• Digital imaging company Ophthalmic Imaging Systems (OIS; Sacramento, California) launched seven new software solutions.
CEO Gil Allon said, "The AAO meeting provides an ideal opportunity to showcase our new and innovative products to customers. With the introduction of these seven new product offerings, we continue to raise the bar for digital imaging and informatics solutions in ophthalmology. We believe that these solutions will serve as a key component of our strategy to gain market share and return OIS to achieving consistent sales growth."
The seven new products introduced at the conference include:
– OIS EMR (Electronic Medical Records), which combines a technologically advanced system architecture and what OIS termed "unsurpassed integration with OIS Symphony Image Management."
– OIS PM (Practice Management), which allows medical professionals to efficiently and accurately manage every aspect of a patient visit — from the scheduling of the appointment to the final payment. Integrated with OIS EMR, the program "dramatically improves the efficiency and quality of care provided by ophthalmic practices."
– Symphony Web, which delivers image and diagnostic review features to any Internet connection via Internet Explorer; it seamlessly integrates with existing installations, allowing users access to images and reports from their database.
– Symphony Draw, which allows users to make drawings using freehand techniques or pre-made stamps to document findings. Through integration with existing platforms, Symphony Draw is launched from either the patient's medical record or as the diagnostic images are reviewed, eliminating the need to re-enter patient information.
– Symphony Link, a vendor-independent back-end application that links the OIS Symphony Review applications with other diagnostic devices within the clinic. With a single click, users can navigate directly from a patient's record within OIS Symphony to the same record in the native viewing software of many popular diagnostic devices.
– PerfectView, which allows users to compare multiple images from multiple dates, using a user-definable and controllable spot to compare changes. OIS said glaucoma specialists can track changes to the optic nerve head by layering images from different dates in order to view disease progression.
– FAF Super-Resolution, which combines multiple Fundus Autofluorescence (FAF) images together to produce a single image with detail and clarity.
Canon U.S.A. (Lake Success, New York) showcased its full line of total digital imaging and workflow management solutions.
"Ever since developing the world's first non-mydriatic retinal camera in 1976, Canon has been a pioneer and leader in the field of retinal imaging," said Tsuneo Imai, senior director and general manager of Canon U.S.A.'s Medical Systems Division.
At its booth, Canon demonstrated the synergy between its line of retinal camera systems and optical coherence tomography (OCT) products from Optopol Technology, including the SPOCT HR, which the company said offers "superior high resolution among available OCT systems, ultra-high scanning speed to shorten data collection and improves comfort during the examination for both the patient and the operator."
Also showcased was the SPOCT, "which allows for non-invasive cross-sectional imaging of the retina, while providing true, fast 3-D imaging."
The automated perimeter PTS 1000 from Optopol Technology also was featured. Canon said the PTS 1000 is "a diagnostic instrument that offers precise and fast testing of the field of vision, featuring a wide range of strategies and analysis tools combined with intuitive interface, providing retinal specialists with a powerful diagnostic tool."
Researchers cite biomarker as AMD signal
A group of researchers from Vanderbilt Eye Institute (Nashville, Tennessee) reported on a potential biomarker for age-related macular degeneration (AMD) that may also imply common biological signaling mechanisms for general aging and AMD.
Another presentation during the meeting, which is the world's largest gathering of eye physicians and surgeons, reported positive results in keratoconus patients treated with a promising new technique known as corneal collagen crosslinking.
Janice Law, MD, and her colleagues at Vanderbilt Eye Institute looked for plasma biochemical markers that would indicate systemic oxidative stress and an inflammatory response in 57 patients with AMD and in an age-matched control group.
In its advanced stages, AMD destroys the detailed, central vision needed to read, drive, recognize faces and enjoy daily life, and is a major cause of vision loss in the U.S.
Law's study group found that an inflammation-promoting biochemical, interleukin 6 (IL-6), was found to be significantly higher in the AMD patients, and IL-6 levels also correlated with oxidative stress measurements in these patients.
They said this suggests that IL-6 is a good candidate for further study as a potential AMD biomarker. It also indicates that common biological signaling mechanisms may be involved in both oxidative stress and inflammation and may contribute to AMD development as well as general aging.
Other recent research has established that AMD is closely associated with certain genetic variations that control aspects of the immune system, especially the inflammatory response. Numerous studies also have confirmed the role of oxidative stress in AMD development and progression.
Law's study focused on plasma-based biomarkers because blood sample screening is a relatively simple yet accurate diagnostic tool. This preliminary cohort study did not attempt to determine whether IL-6 levels varied with AMD types – "wet" AMD, characterized by rapid growth of abnormal blood vessels and heightened risk of vision loss, or the more common "dry" type – or with disease severity.
In another study, co-investigators Mohan Rajan, MD, and Sujatha Mohan, MD, of the Rajan Eye Care Hospital in India, studied collagen crosslinking in 48 patients (60 eyes), aged 12 to 48 years, who had progressive keratoconus.
The collagen crosslinking technique, developed in recent years, is under study for the treatment of several eye disorders. When the technique is used to treat keratoconus patients, drops containing riboflavin, a B-complex vitamin, are applied to the cornea and then the cornea is exposed to UVA light, which stimulates collagen fibers to connect to one another, or crosslink.
The procedure helps restore appropriate curvature and structure to the cornea, and makes it possible for most patients who need them to wear rigid contact lenses again. AAO said collagen crosslinking may prove to be a viable alternative to cornea transplant, and three FDA-approved trials are now under way in the U.S.
Keratoconus is an eye disorder that causes corneal tissue to become abnormally thin and the central area to protrude in a cone shape, distorting vision. In the U.S., keratoconus occurs in 50 to 200 per 100,000 people. The AAO said unofficial reports indicate this disorder may be more prevalent in the Indian subcontinent, Arabia and New Zealand.
In the Rajan-Mohan study, the epithelium (top layer of tissue) was debrided in 40 eyes (group A), while in 20 eyes (group B) the epithelium was left intact prior to treatment. Patients received follow-up exams at one, three, six and 12 months.
Vision corrected with eyeglasses or contact lenses improved in 45% of patients by six months, but no change was noted in any patients' vision when measured without eyeglasses or contact lenses. The corneal curve flattened appropriately in 51 of 60 eyes (85%), with more significant flattening in group A patients. Based on subjective reports, 46.6% of participants were better able to tolerate wearing contact lenses. No significant side effects were noted.
"In our study, collagen crosslinking showed promising results," said Mohan. "The positive corneal changes observed in these patients, together with improved vision and contact lens tolerance, indicates that it was a safe and effective procedure for these keratoconus patients."
AAO said that as a less-expensive, technically simpler procedure, collagen crosslinking could be particularly useful in developing countries where corneal transplant and other procedures may be difficult to access.
Also at AAO, a study that correlates optic nerve damage in glaucoma patients with carotid artery narrowing and potentially elevated risk for stroke was reported by Mostafa Elgohary, MD, of Essex County and Broomfield Hospitals in the UK.
Glaucoma often is associated with elevated pressure inside the eye (intraocular pressure, or IOP), which can damage the optic nerve, leading to vision loss and even blindness.
Elgohary and his colleagues were concerned when several patients who had been under their care for several years continued to lose their vision in one or both eyes even though their IOP had been kept within normal limits either through medicine or surgery.
The authors reviewed 16 retrospective case reports to determine if there was a possible association of internal carotid artery stenosis, with the development of glaucoma or glaucoma-like damage to the optic nerve.
On further investigation, the researchers found that six of those patients had significant carotid artery narrowing (greater than 60% of the artery lumen) and some even had total blockage of the artery on the same side as the eye with the glaucoma, or on both sides. One patient showed improvement in the visual field after undergoing surgery to remove the blockage.
The group then extended the investigation by prospectively collecting data for 58 patients who were referred with similar optic nerve or visual field changes and carotid artery stenosis as part of the hospital audit system and found that 17% of these patients had significant carotid artery narrowing.
The AAO said the UK study results "add to the evidence for the role of reduced blood flow to the optic nerve as a possible cause or predisposing factor for glaucoma or glaucoma-like optic nerve damage." Moreover, the results indicate a possible association with significant carotid artery narrowing which is a potentially serious condition as it carries the risk of stroke.
"The study is of a small scale and will obviously need further research to confirm the findings," the researchers said. "However, in the meantime it may be prudent to consider referring patients with progressive or asymmetric glaucoma despite normal eye pressure – especially in the presence of cardiovascular risk factors such as hypertension, hypercholesterolemia or ischemia heart disease – for carotid artery Doppler scan to pick up those who could be at high risk for stroke and may benefit from carotid artery treatment."
Researchers from University Hospital (Liverpool, UK) reported on a survey that looked at how the practice of fasting, common to the world's seven major religions, may affect patient compliance with treatment for glaucoma and other eye diseases.
Many of the world's religions practice obligatory or voluntary fasting – abstaining from food and often also fluid – during periods that can last from a few days to more than a month, on an annual basis.
AAO noted that increasingly, ophthalmologists in the U.S. and other countries care for patients of diverse backgrounds. "This is accelerating the need for reliable information on the interaction of religious beliefs and compliance with prescribed treatments."
The effectiveness of glaucoma treatment, in particular, often depends on patients' ability and willingness to self-administer eye drop medications on a regular schedule over months or years. Glaucoma patients often notice no symptoms in the early stages of the disease, which poses challenges for physicians in motivating patients to stick to treatment regimens. If patients neglect treatment until their vision noticeably declines, the damage often is irreversible.
Researchers led by Nishant Kumar, of the University Hospital, studied patient compliance in relation to fasting by analyzing 350 surveys completed by members of the worlds' major faiths: Islam, Hinduism, Jainism, Christianity, Judaism, Bahai, and Buddhism (50 surveys per religion).
The researchers believe it is the first study of its kind.
Population reports show that roughly 20% of the world's people are Muslim and about 15% are Hindu, with fasting being of importance to both religions. It is mandatory during the daylight hours of the month of Ramadan for Muslims; for Hindus fasting is generally voluntary.
In the new survey, the majority of patients self-identified as Hindus, Muslims and Jains stated that the use of eye drops during their fasting hours would break their fast, and therefore they would not use drops while fasting.
Those patient groups said they would be more likely to use drops while fasting for painful eye conditions or if vision was affected.
The majority of Christian, Buddhist, Bahai and Jewish survey respondents did not believe that using drops would break their fasts, and said they would use eye drops during their fasting periods.
Kumar said, "A broad awareness among ophthalmologists regarding the religious beliefs of the patient groups they treat will allow them to formulate management plans in keeping with these beliefs without compromising care."