Volume 5, Number 12
Monday, March 28, 2005



In this issue: (click heading to view article)
Editorial: Preparing for the Medicare Debate
Retinopathy and Risk of Congestive Heart Failure
Falls and Health Status in Elderly Women After First Cataract Surgery
In Vivo Confocal Microscopy of Keratic Precipitates
Briefly











Editorial: Preparing for the Medicare Debate

As we observe the current debate about Social Security raging through Main Street, Wall Street and the halls of Congress, let us not forget that Medicare will at some point be up at bat as well. In my opinion, it will be an even bigger beast to tame than Social Security. The costs of the latter may be a bit more predictable in that life expectancies can be estimated and beneficiary payments judged accordingly. With Medicare payouts, projections may not be as easy as that. Undoubtedly, as Baby Boomers grow older, they will use more medical services that are more sophisticated and possibly more costly. Let’s face it--ours is not a society where rationing of health services as a means of cost control will ever be readily accepted. We need to discuss alternative plans to allow for our nation’s obligations toward health care commitments.

One can expect that with a Medicare debate, physicians may once again end up in the line of fire. This may come in the form of reduced reimbursements to physicians, gravitation to a national health services plan, increasing pressure to employ physician extenders or new methods we have yet to deal with. Meanwhile, as physicians, we must reconcile the need to have financially stable practices, remain very efficient in our delivery of health care and assure that we deliver the finest of care in a compassionate fashion.

We are at an important crossroads in medical history. We must insist that physicians be at the table to discuss and craft solutions to this dilemma. We must be viewed as vital individuals, not key obstructions, in the cause of pursuing the answers to Medicare’s problems. The solutions will be complex, compromising and contentious. The best solutions may require new approaches to healthcare delivery that seek ways to reduce the costs of advancing technology, guarantee medical liability reform to assure as little overuse of services as possible, and ensure an honest-to-goodness discussion with Medicare recipients regarding the facts of life. Let us insist on involvement in this debate, for if we are not included, we may be simply told to go to the back room and "make the doughnuts."

Stephen E. Pascucci, MD
Medical Editor
[email protected]

Table of Contents











Retinopathy and Risk of Congestive Heart Failure

Congestive heart failure (CHF) affects a substantial proportion of adults, including those without preexisting coronary heart disease. The pathogenesis of CHF is uncertain, but microvascular disease has been named as a possible factor. A population-based, prospective seven-year cohort study conducted by the Center for Eye Research Australia at the University of Melbourne, aimed to determine the relationship of retinopathy, a marker of systemic microvascular disease, to risk of CHF.

The study was held in four U.S. communities using the Atherosclerosis Risk in Communities Study database. A total of 11,612 participants aged 49 to 73 years had retinal photographs taken between 1993 and 1995. The photographs were graded according to a standardized protocol for the presence of retinopathy (microaneurysms, retinal hemorrhages, soft exudates), arteriovenous nicking, focal arteriolar narrowing and generalized arteriolar narrowing.

The seven-year cumulative incidence of CHF was 5.4 percent (492 events). Participants with retinopathy had a higher incidence of CHF compared with those without retinopathy (15.1 percent vs. 4.8 percent). After controlling for age, sex, race, preexisting coronary heart disease, mean arterial blood pressure, diabetes, glucose level, cholesterol level, smoking, body mass index and study site, researchers found that the presence of retinopathy was associated with a twofold higher risk of CHF (relative risk, 1.96; 95 percent confidence interval, 1.51 to 2.54). Among participants without preexisting coronary heart disease, diabetes or hypertension, retinopathy was associated with a threefold higher risk of CHF (relative risk, 2.98; 95 percent CI, 1.50 to 5.92).

Investigators concluded that retinopathy is an independent predictor of CHF, even in persons without preexisting coronary heart disease, diabetes or hypertension. They believe this suggests that microvascular disease may play an important role in the development of heart failure in the general population, and that some asymptomatic persons with retinopathy on an ophthalmologic examination may benefit from further assessment for CHF risk.

SOURCE: Wong TY, Rosamond W, Chang PP, et al. Retinopathy and risk of congestive heart failure. JAMA 2005;293(1):63-9.
Table of Contents






Falls and Health Status in Elderly Women After First Cataract Surgery

One-third of elderly people fall each year, and poor vision has been associated with increased risk of falls. The authors of a study conducted at England’s University Hospital, Queen’s Medical Center, aimed to determine if first eye cataract surgery in women reduces the risk of falling, and to measure associated health gain.

The study included 306 women older than 70 with cataract, who were randomized to expedited (approximately four weeks’ wait) or routine (12 months’ wait) surgery. Researchers ascertained falls by diary records, with follow-up every three months. They measured health status after six months.

In the operated group, visual function improved: corrected binocular acuity improved by 0.25 logMAR units; eight percent had acuity worse than 20/40, compared with 37 percent of controls. Over 12 months of follow-up, 49 percent of operated participants (76 participants) fell at least once, and 18 percent (28 participants) fell more than once. Forty-five percent of unoperated participants (69 participants) fell at least once, 25 percent (38 participants) fell more than once. Rate of falling was reduced by 34 percent in the operated group. Activity, anxiety, depression, confidence, visual disability and handicap all improved in the operated group, compared with the control group. Four participants (three percent) in the operated group had fractures, compared with 12 participants (eight percent) in the control group.

SOURCE: Harwood RH, Foss AJ, Osborn F, et al. Falls and health status in elderly women following first eye cataract surgery: a randomized controlled trial. Br J Ophthalmol 2005;89(1):53-9.
Table of Contents






In Vivo Confocal Microscopy of Keratic Precipitates

Researchers at the Casey Eye Institute in Portland, OR, recently conducted a study using in vivo confocal microscopy (IVCM) to describe the architecture and heterogeneity of keratic precipitates (KP) in uveitis.

KP were viewed with a scanning confocal microscope in 33 patients seeking care at a tertiary referral uveitis service for immune-mediated and infectious forms of uveitis, including HLA-B27–associated uveitis, sarcoidosis, Vogt-Koyanagi-Harada syndrome, juvenile chronic arthritis, Fuchs heterochromic iridocyclitis, cytomegalovirus retinitis, herpes zoster ophthalmicus, ocular toxoplasmosis and idiopathic uveitis. Images were captured and digitalized in real time.

Forty-two eyes of 33 patients were examined in this study. Patient ages ranged from 22 to 84 years (mean age, 49.4 years). Seventeen (52 percent) of the patients were women and 16 patients (48 percent) were men. The KP ranged from 10 to 350 µm in diameter. Investigators observed the following absolute and speculative outcomes: KP are markedly heterogeneous and variable as documented by IVCM; KP in individual patients are consistent throughout the cornea; the morphologic features of KP change across time; infectious vs. non-infectious causes of uveitis seem to be readily distinguishable by using IVCM; and KP may have consistency for specific disease states and therefore may have diagnostic importance.

The authors believe that their study may mark the first time that IVCM has been used to describe the architecture and heterogeneity of KP in uveitis. They believe that their observations reveal a heterogeneity that cannot be appreciated by conventional slit lamp microscopy.

SOURCE: Wertheim MS, Mathers WD, Planck SJ, et al. In vivo confocal microscopy of keratic precipitates. Arch Ophthalmol 2004;122(12):1773-81.
Table of Contents





BRIEFLY
  • BAUSCH & LOMB SETTLES PATENT DISPUTE WITH ALCON. Bausch & Lomb recently announced a settlement agreement ending its patent dispute relating to Alcon’s ICaps AREDS product. The agreement establishes a cross-licensing relationship that permits Alcon to continue to sell its AREDS-based nutraceutical product worldwide and grants B&L global rights under one or more Alcon patents. The confidential terms of the agreement were approved by B&L’s licensor, the United States Public Health Service. B&L had filed the patent infringement lawsuit against Alcon in U.S. District Court in Rochester, NY, immediately after receiving a patent from the U.S. Patent and Trademark Office for the high-potency antioxidant and mineral formula in the company’s Ocuvite PreserVision dietary supplement, which was demonstrated to preserve eye health and vision in the National Eye Institute’s landmark Age-Related Eye Disease Study (AREDS). B&L co-developed the formula with the NEI and supplied the tablets used in the 10-year AREDS; it holds worldwide patent rights to the AREDS formula under a licensing agreement with the National Institutes of Health and the United States Public Health Service. B&L made the AREDS formulation available to consumers as Ocuvite PreserVision dietary supplements after the results of AREDS were released in October 2001.
  • ISTA PHARMACEUTICALS FILES IND FOR TRIAL OF DRY EYE TREATMENT. ISTA Pharmaceuticals, Inc., has submitted an Investigational New Drug Application (IND) with the FDA to conduct a Phase IIb clinical trial for ecabet sodium, a prescription eyedrop for the treatment of dry eye syndrome. Pending clearance by the FDA, ISTA intends to initiate the Phase IIb trial in the second quarter of 2005. Ecabet sodium represents a new class of molecules that increase the quantity and quality of mucin produced by conjunctival goblet cells and corneal epithelia. The trial is designed to evaluate several ocular signs and symptoms, the results of which will be used to define efficacy endpoints for the Phase III trial; among them are corneal and conjunctival staining, tear film break-up time, burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation and haziness or blurriness. Generally, improvement in one sign and one symptom are considered acceptable by the FDA for approval of a prescription dry eye product.
  • VISX ANNOUNCES FDA APPROVAL OF CUSTOMVUE TREATMENTS FOR MIXED ASTIGMATISM, PRE-ASCRS PRACTICE DEVELOPMENT SEMINAR. VISX, Inc., has received approval from the FDA to market and sell CustomVue treatments for mixed astigmatism. The approval means that VISX CustomVue wavefront-guided treatment is approved for all forms of astigmatism, including myopia with astigmatism, hyperopia with astigmatism and mixed astigmatism. In related news, VISX has announced that it will hold a pre-ASCRS VISX University Practice Development Seminar in Washington, DC, on April 15, 2005, at the Crystal Gateway Marriott. The one-day seminar will offer highlights on CustomVue technology, marketing and up-to-date information on market and industry trends. Attendees can select from primary and advanced courses. Pre-registration deadline is April 8, 2005; registration fee is $100. For more information, go to www.visx.com.


Table of Contents



 Check Yearly. See Clearly. Open Your Eyes To the Opportunities.
It"s only been up and running a few short weeks. Yet, it"s already clear that the Check Yearly. See Clearly.(SM) marketing campaign is opening consumers" eyes to the benefits of regular eye exams. Call the Vision Council of America at 800-424-8422 today or visit checkyearly.com for your free promotional materials.