CooperVision Launches Multifocal Daily Disposable
At Press Time
Malpractice Payments at a Low
The eighth straight year of declines.
■ Medical malpractice payments in 2011 were at their lowest level on record by almost any measure, contrary to beliefs that these payments are to blame for the skyrocketing cost of health care, a new Public Citizen report finds.
In the report, “Malpractice Payments Sunk to Record Low in 2011,” Public Citizen analyzed data from the federal government's National Practitioner Data Bank (NPDB), which tracks malpractice payments on behalf of doctors. The report found that the number of medical payments and the inflation-adjusted value of such payments were at their lowest levels since 1991, the earliest full year for which such data is available.
The report found that in 2011:
► The number of malpractice payments on behalf of doctors (9,758 payments) was the lowest on record, having fallen for the eighth consecutive year.
► The inflation-adjusted value of payments made on behalf of doctors ($3.2 billion) was the lowest on record. In actual dollars, payments have fallen for eight straight years and are at their lowest level since 1998.
► The average size of medical malpractice payments (about $327,000) declined from previous years.
► Four-fifths of medical malpractice awards compensated for death, catastrophic harm or serious permanent injuries. This counters the argument that many claims are frivolous.
► Medical malpractice payments' share of the nation's health care cost was the lowest on record (just 0.12% of all national health care costs).
Patients Respond to Doctor E-mails
They still show a preference for telephone contact.
■ According to a study presented at the recent ARVO meeting by the Wills Eye Foundation, patients are coming around to receiving information from doctors on their electronic devices.
While traditional phone calls to landlines still dominated patients preferred method of being contacted, with 55% opting to receive information and reminders that way, the second most preferred method was e-mail, which garnered support from 43.1% of patients polled.
In a 1-5 Likert scale, patients rated e-mail communications at 4.4 in terms of comfort of use. Receiving text messages from a doctor's office was less popular, with only 14.5% interested in that method. The use of social networking sites like Facebook lags behind with only 3.7% interest in receiving information from a vision care professional.
The study polled 400 ophthalmic patients beginning in July 2011. Men made up 36% and women 64% of the study. Of those who reported their age, most, 32.3%, were between 45 and 65 years. Patients between ages 66 and 75 accounted for 17.5%, 14.9% were over 75 and 12.3% were 18 to 45 years old. Of those polled, 82.8% owned a cell phone, even more than the 77.6% who owned a home phone. While 69% owned a computer, only 15.3% owned a tablet computer.
Martinez P, et al. An assessment of ophthalmic patients' utilization of technological devices and social media platforms. ARVO 2012 (abstract).
Promising Ultrasound Glaucoma Treatment
EyeTechCare says early results lead to large study.
■ EyeTechCare, an ophthalmic device company based near Lyon, France, has announced positive preliminary results from a 60-patient clinical study conducted at nine sites in France using high-intensity focused ultrasound (HIFU) for the treatment of refractory but less advanced glaucoma. More extensive studies are now under way.
The preliminary study results, covering six months of a planned one-year follow-up, were presented recently at the European Glaucoma Society Congress in Copenhagen. The main findings of the study were that treatment with the company's Ultrasonic Circular Cyclo-Coagulation (UC3) procedure showed that between 82% to 90% of patients responded favorably, with an average reduction in IOP of 42% to 49%. Patients had been divided into two groups, with the patients receiving the longer-duration (6-second) pulse generally achieving a lower IOP than those receiving the shorter 4-second application.
To avoid multiple laser applications that are an occasional source of error and lack reproducibility, EyeTechCare has designed a device with innovative geometry, enabling the entire circumference of the eye to be treated in a single procedure. This proprietary technology incorporates miniaturized transducers in a ring-shaped device, which allows EyeTechCare's EYEOP1 device to become the first circular non-invasive treatment, offering very high precision, perfect repeatability from one patient to another and an extremely simple procedure resulting in a very short treatment time averaging 1 minute.
While it remains to be demonstrated clinically, it would appear that the device affects both the production and the drainage of aqueous humor.
The method shows efficacy even with patients presenting advanced glaucoma and having undergone several unsuccessful surgical interventions, a large number of medications and a high initial IOP. The new therapy confirms, as in an earlier small pilot study, an extremely favorable risk profile as no major side effects have been observed almost two years after the start of treatments and with more than 70 patients treated.
Similarly, the excellent tolerability of the treatment was confirmed. Eyes present very few signs of inflammation. There were no postoperative IOP spikes or pain in more than 95% of the patients.
EyeTechCare has recently begun an extensive international study called EyeMUST2, which will ultimately involve 12 centers in six countries.
It will cover 120 patients with the aim of gathering clinical data from different centers on patients more representative of the standard glaucoma population and with a longer elapsed time. The first results should be available in early 2013.
|In the News …|
|■ QLT restructures business goals. QLT Inc., best known as the developer of Visudyne photodynamic therapy for the treatment of wet AMD, has decided to focus its efforts on the development of its synthetic oral retinoid program in critical orphan indications. The first two indications for this program are Leber congenital amaurosis (LCA) and retinitis pigmentosa (RP). QLT hopes to be in pivotal clinical trials for LCA no later than the first quarter of 2013 and for RP no later than the end of the second quarter of 2013.|
The company has also retained Goldman Sachs to explore the sale or spinoff of its proprietary punctal plug delivery system and to determine whether it should retain or explore opportunities to partner or sell its Visudyne business. In the interim, QLT will offer Visudyne as a treatment option to patients in the United States.
■ Dr. Chu receives AAO achievement award. Minnesota ophthalmologist Y. Ralph Chu, MD, has been honored with the Senior Achievement Award from the American Academy of Opthalmology. The award recognizes individuals for their contributions to the Academy through instruction, participation and other areas of service such as counselors, representatives, committee members, authors, reviewers of Academy materials and support of advocacy efforts.
Dr. Chu is an internationally recognized physician instructor on cataract and intraocular lens implantations, phakic lens implantations, laser vision correction technologies and ocular therapeutic treatments. As a solo practitioner, he founded Bloomington-based Chu Vision Institute in 1999.
■ Topcon marks 80 years. Topcon Corporation is celebrating 80 years of offering innovative products to eyecare professionals worldwide. Founded in Japan in 1932, the company was first known for its binoculars and cameras. Today, Topcon has an ophthalmic product line that includes the KR-1W Wavefront Analyzer and the DRI OCT-1 Swept Source OCT.
Scleral Lenses for Ocular Surface Disease
They help improve visual acuity in many cases.
■ Scleral lenses effectively help manage a variety of ocular surface conditions, according to a study by Mayo Clinic researchers. The study was conducted to observe the use of Jupiter scleral lenses in patients with ocular surface disease in an outpatient setting.
Not only did the lenses protect the ocular surface, but the majority of patients also reported improved visual acuity.
In the study, 114 patients (185 eyes) were prescribed scleral lenses. Of those eyes, 65 were patients with uncomplicated dry eye syndrome, 23 were patients with chronic graftvs-host disease, 19 with exposure keratopathy, 17 with neurotropic keratopathy and the rest with a variety of ocular conditions.
Jupiter scleral lenses were fit onto patients between June 2006 and November 2011. Most of those patients had tried other forms of intervention including lubricant drops, oral antibiotics and punctual occlusion.
Completion of the fitting process took three visits on average and 100% of the patients successfully wore the lenses.
M Schornack, et al. Scleral lenses in the management of ocular surface disease. ARVO 2012 (abstract).
|In the News …|
|■ CMS proposes 2013 ASC payment rates. CMS has issued preliminary ASC payment rates for 2013 that the Outpatient Ophthalmic Surgery Society (OOSS) has calculated will amount to a 1.3% overall increase in ASC reimbursement. This proposal still leaves a wide differential between payments for procedures performed in ASCs and the same procedures done in hospital outpatient departments (HOPDs). The differential could be as much as 40% in favor of HOPDs.|
For physician fees, CMS proposes a 1% increase for ophthalmology overall. This is better than many specialties, which are slated for cuts averaging 2% to 4% to offset a significant increase in payments for primary care providers.
In addition, CMS says future applications for new technology IOLs (NTIOLs) should be based on labeling that includes a claim of specific clinical benefit that is the result of a new lens characteristic. The agency wants to see proof of “measurable, clinically meaningful, improved outcomes.” Approved NTIOLs qualify for an additional $50 reimbursement in the ASC facility fee.
Public comments will be invited on the 2013 proposals.
■ Survey: Medicare seen as superior insurance. Medicare patients are more satisfied with their health insurance, have better access to care and are less likely to have problems paying medical bills than people who get insurance through employers or those who purchase coverage on their own, according to a new Commonwealth Fund study published by Health Affairs. The telephone survey encompassed 4,004 people age 19 and older.
The survey found that only 8% of Medicare beneficiaries rated their insurance as fair or poor, compared with 20% of adults with employer insurance and 33% who purchased their own insurance.
■ OptiMedica Catalys wins R&D award. The OptiMedica Catalys Precision Laser System for femtosecond laserassisted cataract surgery has been selected as a winner of an R&D Magazine's R&D 100 award. The awards recognize the 100 most technologically significant products introduced into the marketplace over the past year.
■ Plasma seen as an anti-infective. With concerns growing about increasing microbial resistance to ophthalmic antibiotics, Pennsylvania ophthalmologist David S. C. Pao, MD, believes he may have found a safe and effective alternative to antibiotics in a nonthermal plasma formulation that could be delivered using a small probe.
Dr. Pao has been working with plasma experts at Drexel University, Philadelphia, to develop his concept under an innovation grant from Wills Eye Institute.
Dr. Pao told Ophthalmology Management that preliminary experiments with ionized plasma have shown a reduction in bacterial culture counts, healing of corneal ulcers in rabbits and healing of a patient's eyelid lesion that was resistant to antibiotics.
Dr. Pao noted that plasma has already been used successfully in ophthalmology with the Fugo plasma blade for anterior capsulotomy and the YAG laser.
Looking ahead, he said that, with advances in ophthalmic instrumentation, nonthermal plasma has the potential to “provide routine operative and postoperative plasma treatment of surface wounds, particularly in cataract surgery and its postoperative care as well as in intravitreal injections,” where plasma would be used as a prophylactic for the prevention of endophthalmitis.
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► British nystagmus study. Three years ago, the Leicester Nystagmus Survey results were published. In the July 2012 issue of the British Journal of Ophthalmology, some of the co-authors of that study reported on the effects of nystagmus on daily living.
In semistructured interviews with 21 patients about those areas of daily life that are affected by nystagmus, the authors identified six domains affected by the disease: visual function, restriction of movement, standing out/not fitting in, feelings about one's self, negativity about the future and interpersonal relationships.
The interviews revealed universally negative experiences of people living with nystagmus, similar to studies on strabismus. Unable to find previous studies on quality of life with nystagmus, the authors indicated existing QOL instruments might be insensitive to issues suffered by people with nystagmus, and recommended development of a nystagmus-sensitive QOL tool.
► Glaucoma diagnostic study. The July 2012 Archives of Ophthalmology included a comparison of standard automated achromatic perimetry (SAP), multifocal visual evoked potential technique and OCT, to determine why they often result in different findings. All eyes were submitted to all three tests. Eyes with worse standard deviations on SAP were found to be abnormal on at least one of the tests 68% of the time. Among eyes with better standard deviations, the tests were only consistent in 21% of eyes.
False-negative results were found to have been caused by limitations of the techniques applied or individual variability, suggesting that despite the discrepancies, these tests might be in better agreement than the statistics would seem to suggest. The authors suggested using continuous probability scales or time-based comparisons in the same patient to minimize variability among diagnostic techniques.
► Corneal biomechanics in keratoconus. What biomechanical changes occur in the cornea due to keratoconus? An article in the August 2012 Cornea offered some answers. Eyes with keratoconus were submitted to an air-pressure test, measuring the response with an ocular response analyzer, as well as corneal topography and pachymetry.
The authors found that with increasing keratoconus severity, the cornea was thinner than in control eyes. Further, the speed of corneal concave deformation past applanation was quicker, and the tear film index was lower. Corneal curvature and central corneal thickness were responsible for changes in keratoconus severity.
Because the etiology of keratoconus is still unknown, the authors stated corneal biomechanical data might detect corneal changes and help diagnose keratoconus with 15% higher sensitivity than standard keratometry alone.
► Long-term IOL effects. The August 2012 issue of American Journal of Ophthalmology included a study of longterm effects on visual function of surface light scattering and glistening from implanted IOLs. Comparing eyes implanted with acrylic, silicone or polymethyl methacrylate (PMMA) IOLs, all of which were hydrophobic, the investigators conducted VA and glare tests, as well as tests to detect higher-order aberrations (HOAs).
Although acrylic lenses caused greater light scattering than the two other types of lenses, VA and HOA measurements were not significantly different among the three lens types. However, mean corrected VA was better with acrylic lenses.
Study results also confirmed recent studies that posterior capsular opacification was less prevalent with acrylic IOLs than with silicone or PMMA lenses. Although surface scattering with acrylic IOLs can remain significant for many years, it does not impair visual function.
► Pediatric dry eye symptoms. Children are theoretically more resistant to dry eye symptoms because of a more active lacrimal system and less resistant because of their greater use of computers and video games. An article published online in July by Graefe's Archive for Clinical and Experimental Ophthalmology reports that children with dry eye conditions might report less severe symptoms than adult patients.
Forty-five pediatric patients were compared with 45 adults, analyzing data from fluorescein staining, tear film breakup time, Schirmer test scores, ocular system disease index (OSDI) scores and visual analog scale (VAS) scores.
While no significant differences were detected with regard to ocular surface signs, tear film tests or Schirmer testing, both the OSDI and VAS scores were significantly lower in the pediatric group, indicating that children with dry eye symptoms may report fewer symptoms compared to adult patients, even when the extent of ocular surface damage is comparable.
► Normal optic nerve head parameters. Conventional clinical wisdom holds that you must understand the characteristics of a normal disk to be able to identify an abnormal optic disk. Based on that premise, the July-August 2012 issue of Survey of Ophthalmology included a major review of techniques for measuring normal optic nerve head parameters.
The authors covered recent research on planimetry, retinal tomography and OCT, and took into consideration factors such as normal ethnic variation in optic nerve head parameters. They reviewed a total of 186 articles, from an original pool of nearly 1,400 published since 2000, and summarized recent data on the normal morphology and measurement of optic nerve head parameters as assessed by the major imaging modalities.
Timely and Important Retina News of Interest to All Ophthalmologists
Compiled by Andrew E. Mathis, PhD, Medical Editor
► FDA panel recommends Lucentis for DME and ocriplasmin for VMA. The FDA Advisory Committee that reviews ophthalmic drugs has recommended that the FDA approve Lucentis for diabetic macular edema (DME) and ocriplasmin for symptomatic vitreomacular adhesion (VMA). The panel typically carries some weight with the FDA but does not assure final approval.
The panel recommended both the 0.3 mg and 0.5 mg formulations of Lucentis, but cited a slightly higher mortality rate with the 0.5 mm dose in a clinical trial. Retina specialists have commonly used Lucentis off-label by for years as a treatment for DME.
If ocriplasmin gains final approval, it will be the first pharmacologic treatment for VMA, which encompasses such conditions as macular hole. Until now, VMA has been treated only with surgery. ThromboGenics developed Ocriplasmin, and Alcon is now an international partner.
► Lucentis, QOL and patient preferences. There's no question that Lucentis is effective in treating wet AMD, but how does it affect quality of life and patient preferences? An article in the July 2012 issue of the British Journal of Ophthalmology addressed this question.
Fifty-five patients were given four questionnaires after receiving three monthly intravitreal injections of Lucentis. Not only did the patients' vision improve, but the mean score on the QOL questionnaire increased. Regarding patient preference, time trade-off, a measurement of treatment utility, also increased significantly, and this increase was positively correlated with the increase in VA.
The authors concluded the article by noting that because better or worse eye treatment was not associated with utility measurements, the gain in utility from better or worse eye treatment could be similar.
► Retinal detachment following phaco. Retinal detachment is a rare but serious adverse event following phacoemulsification. The July 2012 issue of Archives of Ophthalmology reported on risk trends over 10-plus years. The authors of this Australian study performed a retrospective analysis of available data on phaco cases performed in Western Australia between January 1989 and December 2001, paying close attention to certain risk factors for RD.
Of more than 65,000 phaco cases found in the database, only 23 cases developed RDs, indicating a 10-year cumulative risk of 0.68%. Younger age and male sex were identified as risk factors for RD, as was failed IOL insertion, which incurred a five-fold increase in risk, although this risk was not significant on one of the tests used. Another highly significant risk factor was anterior vitrectomy.
The authors concluded, based on the data, that the risk of RD following phaco decreased by almost 50% over the 10-year period under study, which they attribute to the surgeon learning curve.
► PDR and lipids. With continuing lack of clarity over the relationship between blood lipid levels and proliferative diabetic retinopathy (PDR), ophthalmologists in China undertook a study to determine whether three of these lipids — apolipoproteins A1, B and E — were correlated with PDR or with very mild nonproliferative DR, publishing their findings in the July 2012 issue of Graefe's Archive for Clinical and Experimental Ophthalmology.
The study authors found that, compared with the PDR patient group, subjects with very mild nonproliferative PDR had increased HDL cholesterol and apolipoprotein A1 levels, as well as a higher ratio of apolipoprotein A1 levels to apolipoprotein B levels. After adjusting the data for the ages of the patients, a low ratio of apolipoprotein A1 to apolipoprotein B was significantly associated with PDR in patients with type 2 diabetes of more than 15 years in duration.
The study results suggested that certain factors other than glycemic index might be used to determine the level of risk of PDR, and the aforementioned ratio might have predictive value. Conversely, a high value for that ratio might confer some level of protection against PDR.
► Iluvien has EU approvals. Alimera Sciences Inc. has announced that it has received authorization to market Iluvien in two more European Union nations for the treatment of diabetic macular edema that has not responded to available therapies. The latest approvals are for France and Germany, following earlier approvals in the UK, Austria and Portugal.
“Iluvien has now been granted marketing authorizations in five of the seven EU countries in which we have applied. We are continuing to work with regulatory authorities in Italy and Spain,” said Dan Myers, president and CEO of Alimera.
Iluvien is a sustained-delivery intravitreal insert that delivers approximately 0.2 µg per day of fluocinolone acetonide, a corticosteroid, for up to three years. It does not require sutures and can be injected in a physician's office.
► High myopia study. The worse that myopia is, the more serious the retinal complications can be, including choroidal neovascularization. The July 2012 issue of Retina featured an article evaluating possible predictive factors for VA in eyes with high myopia (≥6 D).
Using enhanced depth imaging OCT, two patient groups, one in New York and one in Iwate, Japan, were submitted to several foveal and subfoveal measurements. The statistical analysis indicated that choroidal thickness in high myopia is inversely correlated with increasing age and myopic refractive error. They study authors noted that choroidal thickness could be a predictor of VA. OM
Ophthamology Management, Volume: 16 , Issue: August 2012, page(s): 10 - 18