SynergEyes Hybrid Contact Lenses Provide A Vision Solution For Post LASIK Patients

SynergEyes, Inc., of Carlsbad, CA,
recently launched a revolutionary hybrid contact lens designed for people
who need further vision correction after undergoing refractive vision
surgery. SynergEyes(R) PS (post-surgical) is also designed for patients who
have experienced some type of corneal trauma or suffer from certain
degenerative vision conditions.

Every year, millions of people undergo LASIK or other types of vision
correction surgery to restore vision and eliminate the need for glasses or
contact lenses. But according to the U.S. Food and Drug Administration
(FDA), approximately 5 percent of LASIK patients are dissatisfied with
their outcome and experience post-operative conditions like eye pain,
blurred or double vision and difficulty driving at night.

Because LASIK permanently alters the shape of the eye, traditional
contact lenses and glasses often cannot provide the additional vision
correction needed. This is why SynergEyes has developed a revolutionary
contact lens designed specifically to address the technical challenges of
restoring vision to these patients offering them consistent, predictable
vision, even at night.

Approved for marketing by the FDA, SynergEyes(R) PS hybrid contact
lenses combine two materials — a rigid gas permeable center with a soft
lens outer skirt. The “hybrid” design bonds a “hard” and “soft” contact
lens together resulting in a one-of-a-kind vision correction option that
provides crisp, clear vision for surgically altered corneas in a
comfortable, healthy contact lens.

“The SynergEyes(R) PS lens has proven to be a safe, effective and
comfortable lens for the restoration of post-surgical vision loss,” says
Dr. Edward Boshnick of Miami, FL. “It has become my first choice lens for
the treatment of patients who have lost quality vision and comfort due to
refractive and corneal transplant surgery.”

Until being fit with SynergEyes(R) PS, Gabriel Meneses, a patient of
Dr. Boshnick, had been struggling daily with post-LASIK side effects like
blurry vision, ghosting and migraines after having the surgery six years
ago. His vision could not be adequately corrected with eyeglasses or other
contact lenses. “Dr Boshnick gave me the opportunity to be one of the first
to try the new SynergEyes(R) PS lens … all I can say is what a
difference! As for vision quality, this lens has definitely offered me the
best I’ve experienced so far.”

Incorporating patented HyperBond(TM) technology and HydrolEyes(TM)
surface science, the SynergEyes contact lenses with FDA market clearance
include SynergEyes(R) A for naturally occurring ametropia, targeting
patients with astigmatism, current gas permeable lens wearers, and patients
demanding optimized vision; the SynergEyes(R) KC for keratoconus, the
SynergEyes(R) Multifocal lens for presbyopia and the SynergEyes(R) PS for
post-surgery and post trauma refractive errors.

SynergEyes, Inc.

Mixed Results From ACCORD: Study Found No Overall Reduction In Cardiovascular Risk, But Benefits To Eyes, Kidneys And Nerves

Five-year results of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study confirm that neither more intensive lowering of blood glucose (sugar) levels, more intensive lowering of blood pressure, nor treatment of blood lipids with a fibrate and a statin drug reduce cardiovascular risk in people with established type 2 diabetes who are at severely high risk for cardiovascular events. However, the study did find improvements to microvascular conditions, such as progression of diabetic eye disease (retinopathy), visual acuity, and renal and nerve function. The landmark study is sponsored by the federal government through the National Institutes of Health (NIH).

Speaking at the American Diabetes Association’s 70th Scientific Sessions®, the ACCORD Study Group cautioned that any potential benefits must be weighed against the increased risk of mortality and episodes of seriously low blood glucose that were seen to accompany intensive lowering of blood glucose levels — which in ACCORD was focused on achieving normal A1C levels in the study population. They emphasized that both the positive and negative results of the study apply only to this population of middle-aged or older people with type 2 diabetes for an average of 10 years, who also had a history of cardiovascular disease (CVD) or at least two risk factors for CVD.

“These results underscore the importance of patient-centered care that stresses individual treatment choices made in consultation with a physician,” said Denise Simons-Morton, MD, Ph.D, Director of the Division for the Application of Research Discoveries at the NIH’s National Heart, Lung and Blood Institute (NHLBI), the primary sponsor of the study. “Within this group, it’s important for patients and doctors to decide the highest priority for the patient,” she said. “Is improved eye health worth a higher risk of death and low blood sugar episodes? That’s a question only a fully informed patient can answer.”

The ACCORD researchers set out to investigate whether cardiovascular risk in people with type 2 diabetes could be reduced using one of the following strategies, each compared with standard treatment: intensive lowering of blood glucose to near-normal levels (target A1C less than 6%), intensive lowering of blood pressure to near-normal levels, or treatment of blood lipids with a combination of fibrate and statin drugs. It also looked at how each of these treatments would affect other outcomes such as mortality and microvascular outcomes (e.g., eye, kidney and nerve complications).

NHLBI prematurely halted the intensive blood-glucose lowering strategy after 3.5 years, in February 2008, due to safety concerns caused by an unexpected higher incidence of death in the intensive glucose lowering treatment group compared with the standard treatment group. Patients in the intensive treatment arm of the study were transitioned into the standard treatment arm for the remainder of the trial’s five years, which has now concluded.

Intensively Lowering Blood Glucose: Increased Mortality and No Cardio Benefit, But Possible Benefits to Eyes, Kidneys and Nerves

Results of intensive glucose lowering on microvascular outcomes were published today in the Lancet and presented at a symposium at the American Diabetes Association’s 70th Scientific Sessions in Orlando.

The study examined patients who underwent intensive glucose-lowering treatment for 3.5 years (increased medication aimed at lowering A1C levels to less than 6 percent) and were then given standard treatments (aimed at achieving A1C levels of 7.0-7.9%) for the remaining 1.5 years, compared with standard treatment for the duration of the study. The intensively treated patients did not see a reduced incidence of cardiovascular disease.

In addition, the groups did not differ in overall measures of microvascular health, for example, in the progression rates to kidney failure, major vision loss, or advanced peripheral neuropathy, a common nerve problem in diabetes that usually begins as tingling or numbness in the feet. However, there were some microvascular improvements noted, such as a reduced incidence of albuminuria (protein in the urine, a marker of kidney disease) in the intensive group, compared to those receiving standard treatment, along with fewer cataract extractions during the study period. Visual acuity (sharpness of vision) and nerve function scores were also better for the intensive group than for the standard-treatment group, suggesting that intensive lowering of blood glucose may also help prevent eye and nerve damage.

“Patients who develop macroalbuminuria are prone to renal failure and cardiovascular events,” said Faramarz Ismail-Beigi, MD, Ph.D, of Case Western Reserve University and the lead researcher on this portion of the study. “Less protein in the urine is a very good sign.”

Though the visual acuity tests were somewhat subjective, Ismail-Beigi said, they could indicate that intensive glucose lowering helps to prevent eye damage.

Intensively Lowering Blood Glucose, Treating Lipids: Slows Retinopathy Progression

That finding is further supported by a substudy of ACCORD chaired by Emily Chew, MD, chief of the Clinical Trials Branch of the Division of Epidemiology and Clinical Applications at the NIH’s National Eye Institute (NEI). Results of the study were published online in the New England Journal of Medicine today. Chew and her colleagues investigated whether each treatment arm of the ACCORD trial — blood glucose, blood pressure, and blood lipids — would reduce the progression of diabetic eye disease (or retinopathy) in a subset of about 3,000 ACCORD study participants, compared to that treatment’s standard approach. Disease progression was identified through retinal photographs that indicated blood vessel changes or by the need for laser or vitrectomy surgery to treat abnormal blood vessels.

The study found that people in the intensive blood glucose lowering arm, as well as those who received a combination of a fibrate and a statin for blood lipids, experienced slower progression in diabetic retinopathy than those in each standard treatment arm. Those who were in the intensive blood pressure lowering arm did not see a reduction in eye disease progression when compared to people receiving standard blood pressure control.

Compared with standard blood glucose control, intensive control decreased the progression of diabetic retinopathy by about one-third, from 10.4 percent to 7.3 percent, over four years. Participants in the intensive control group had a median blood glucose level of 6.4 percent hemoglobin A1C — a level close to values in people without diabetes. The standard blood glucose control group maintained a median level of 7.5 percent.

In addition, compared with simvastatin treatment alone, combination lipid therapy with fenofibrate plus simvastatin also reduced disease progression by about one-third, from 10.2 percent to 6.5 percent, over four years. No prior clinical trial has shown that the combination of fenofibrate and simvastatin reduces diabetic eye disease progression.

Contrary to predictions, there was no difference in diabetic retinopathy progression among participants treated to an intensive systolic blood pressure (the top number in a blood pressure reading) target of less than 120 mm Hg, compared with those treated to a standard target of less than 140 mm Hg.

“The results of the ACCORD Eye Study indicate that intensive blood sugar control and combination fibrate plus statin treatment of lipids independently reduce diabetic retinopathy progression,” Chew said. “However, patients and their doctors should work together to develop an individual treatment plan, taking into account the potential risks of intensive glucose treatment.”

Combination Lipid Treatment: No Cardio Benefits Overall, But Subgroup May See Reduced Risk

Combination lipid therapy with a statin plus a fibrate did not help lower cardiovascular risks overall, but the results did suggest that a subgroup of the study — those with high triglycerides and low HDL (the so-called “good” cholesterol) — may benefit by such treatment.

In this subpopulation of the investigation, which included about 15 percent of the 5,518 people studied in the ACCORD Lipid Trial, those who had triglyceride levels of more than 200 and HDL levels below 34 saw a reduced incidence of cardiovascular events of 30 percent. These findings are supported by similar findings of subgroup populations in several large previously published clinical studies.

“If it were an isolated finding in our study I’d be less enthusiastic,” said Henry Ginsberg, MD, Irving Professor of Medicine and Director of the Irving Institute for Clinical and Translational Research at Columbia University. “But this finding is in line with subgroup analyses in several other trials.”

A second subgroup analysis of this arm of the study found that women and men respond differently to combination lipid therapy, Ginsberg said. Though overall the study found no cardiovascular benefits for the study population, when broken down by gender, the results showed men experienced a 20 percent reduction in cardiovascular events, while women experienced a 38 percent increase in cardiovascular events.

However, when examined for statistical significance, “the data for men showed a strong indication that they benefitted, while the data for women were not as conclusive,” Ginsberg said. “This raises possibilities that need to be further examined.”

These results were published in the April 29, 2010, issue of the New England Journal of Medicine.

Intensively Lowering Blood Pressure: No Cardio Benefits, But Suggested Reduction in Stroke

Results from the intensive blood pressure control arm of the study were also published in April in the New England Journal of Medicine. In this treatment arm, participants lowered blood pressure levels to “normal” levels of less than 120 mm Hg, to see if doing so would reduce major cardiovascular events, compared with standard treatment of levels less than 140 mm Hg. No significant reduction in overall CVD events was found.

The study did find a significant (41 percent) reduction in stroke, which was consistent with other BP-lowering clinical trials. However, because this was not the primary focus of the study, and because the overall rate of stroke was low, the researchers are hesitant to recommend a strategy of lowering blood pressure to this degree without further study.

“Older patients with known cardiovascular disease, higher blood pressure to begin with, and African Americans may benefit from such a treatment plan,” said William Cushman, MD, of the Memphis Veterans Affairs Medical Center, “but we’re going to have to do further analyses.”

The NHLBI is the primary sponsor of ACCORD, with additional funding and scientific expertise contributed by the National Institute of Diabetes and Digestive and Kidney Diseases. Other components of the NIH — including the National Institute of Aging — as well as the Centers for Disease Control and Prevention, support substudies. The following companies provided study medications, equipment, or supplies: Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare Inc., GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals, Inc., Novo Nordisk, Inc., Omron Healthcare, Inc., Sanofi-Aventis U.S., and Takeda Pharmaceuticals, Inc.

American Diabetes Association

View drug information on Fenofibrate.

Carl Zeiss Meditec Delivers Key Technological Advances In Optical Coherence Tomography

Carl Zeiss Meditec, a leader in ophthalmic devices and surgical systems, announced today that two new optical coherence tomography (OCT) applications will be available for the first time at the American Society of Cataract and Refractive Surgeons (ASCRS) meeting in Chicago, IL at booth 2028. With advanced algorithms available for Cirrus™ HD-OCT and Stratus™ OCT, ophthalmologists now have the most advanced imaging capabilities available for assessing and managing glaucoma and diseases of the retina.

The Cirrus HD-OCT, the latest addition to the Zeiss OCT family of products, provides the most detailed scan patterns and layer maps available for identifying retinal and glaucoma disease characteristics, and monitoring disease progression. Nearly 1000 Cirrus HD-OCT units have been sold worldwide since its introduction last November. It is the first in its category to deliver high-definition 3D maps to spectral domain technology.

“The Cirrus HD-OCT 3-D images bring us a new level of insight into the detailed structure of the retina,” said Peter K. Kaiser, MD, Director of the Clinical Research Center, Cole Eye Institute in Cleveland. “Combined with the proprietary image analysis algorithms developed by the veteran Zeiss team, the Cirrus gives us new volumetric data that expands our ability to interpret the three dimensional images in a highly reproducible, quantitative fashion.”

For the first time, Stratus OCT features both Advanced Serial Analysis and Guided Progression Analysis™ (GPA) software for objective measurement and subjective clinical evaluation in the detection of glaucoma and retinal diseases. Advanced Serial Analysis plots RNFL thickness over time and reports statistically significant change, enabling practitioners to project future vision loss and make timely treatment decisions.

Stratus OCT is the standard of care system for comprehensive retinal scanning. With nearly 9,000 Stratus OCT units in use worldwide, more than 37,000 scans performed each year and backed by over 100 U.S. clinical studies for retinal disease, the Stratus OCT is the most widely adopted and researched OCT system in the world.

“From pioneering the first OCT platform nearly a decade ago to launching the newest Cirrus HD-OCT system late last year, Zeiss continues its tradition of leadership with spectral domain technology,” said Jim Taylor, Carl Zeiss Meditec president and chief executive officer. “The new features for the Cirrus and Status OCT systems provide efficiencies that allow physicians to more easily gather and interpret detailed disease information while streamlining workflow processes that impact the entire practice. Our ultimate goal is to enable our customers to provide the best quality of care possible to their patients.”

Optical coherence tomography (OCT) is an imaging method that uses light to scan the retina, and can be performed on undilated pupils as small as 3 mm in diameter. It provides detailed, real-time information about the structure of the living eye available to the clinician. Using light to scan the retina and optic disc, this pioneering technology brought new clinical tools for the diagnosis and management of retinal disease and glaucoma.

About Carl Zeiss Meditec

Carl Zeiss Meditec AG (ISIN: DE 0005313704) is one of the world’s leading medical technology companies. This market position is based on over 160 years of experience in optical innovation.

The company has two primary areas of activity: In the field of ophthalmology Carl Zeiss Meditec offers integrated solutions for treating the four main eye ailments: vision defects (refraction), cataract, glaucoma and retinal disorders. The company’s system solutions are employed in all phases of the disease management, from diagnosis to treatment and aftercare. Carl Zeiss Meditec has always applied its technological expertise to product innovations. These innovations range from basic systems such as slit lamps and fundus cameras to standard setting diagnostic systems such as the Humphrey® Field Analyzer, the Stratus OCT™ and the IOLMaster®, through to the surgical microscopes and innovative treatment systems in refractive laser surgery. The product portfolio in ophthalmic surgery is rounded off by intraocular lenses and consumables.

In the field of neuro and ENT surgery, Carl Zeiss Meditec is the world’s leading provider of surgical microscopes and microsurgical visualization solutions for a very broad range of applications, such as tumor and vascular surgery in the head region and/or spinal surgery. The most recent example of the innovative performance in the area of microsurgery is the OPMI Pentero® visualization system, which allows efficient and ergonomic patient treatment. Carl Zeiss Meditec will systematically expand its product range in this area and become a solution provider in neuro and ENT surgery as well.

Carl Zeiss Meditec’s medical technology portfolio is rounded off by visualization systems for doctors in private practice and promising future technologies such as intraoperative radiation therapy, which allows the targeted treatment of breast cancer and brain cancer directly during surgery.

Carl Zeiss Meditec AG is based in Jena, Germany, with subsidiaries in Germany (Carl Zeiss Surgical GmbH, Carl Zeiss Meditec Vertriebsgesellschaft mbH, *Acri.Tec AG and Carl Zeiss Medical Software GmbH), the USA (Carl Zeiss Meditec, Inc., Dublin), in Japan (Carl Zeiss Meditec Co., Ltd., Tokyo), Spain (Carl Zeiss Meditec Iberia S.A., Madrid) and France (Carl Zeiss Meditec S.A.S., La Rochelle, and Carl Zeiss Meditec France SAS, Le Pecq).

Carl Zeiss Meditec

Dark Or Yellow Leafy Vegetables Reduced Risk Of Cataracts

A woman who consumes plenty of dark leafy vegetables which are rich in lutein and zeaxanthin, as well as sufficient vitamin E from supplements/foods seems to have better protection against developing cataracts, says an article in Archives of Ophthalmology (JAMA/Archives), January issue.

The researchers explain “The oxidative hypothesis of cataract formation posits that reactive oxygen species can damage lens proteins and fiber cell membranes and that nutrients with antioxidant capabilities can protect against these changes.”

It is accurately believed that vitamin E, vitamin C, beta carotene, lutein and zeaxanthin are effective antioxidants. Lutein and zeaxanthin are the only carotenoids that are present in the human eye lens – they may protect us against cataracts by filtering damaging blue light. Carotenoids are natural fat-soluble pigments found in certain plants.

William G. Christen, Sc.D., Brigham & Women’s Hospital and Harvard Medical School, Boston, and team looked at dietary data from 35,551 female health professionals who had taken part in the Women’s Health Study (1993). The women were monitored for 10 years (average). The diets of the women who developed cataracts were compared with the diets of the women who remained cataract-free.

The researchers report that 2,031 women developed cataracts during the ten-year period. They split the women into five groups, depending on how much lutein and zeaxanthin they consumed. They found that –

— Women who consumed about 6,716 micrograms (top group) of lutein and zeaxanthin per day had an 18% lower likelihood of having cataracts, compared to the women who consumed 1,177 micrograms (bottom group) per day.

— The 20% highest consumers of vitamin E from food/supplements, approximately 262.4 milligrams daily, had a 14% lower chance of developing cataracts, compared to the 20% lowest consumers who consumed 4.4 milligrams per day.

The researchers wrote “In conclusion, these prospective data from a large cohort of female health professionals indicate that higher intakes of lutein/zeaxanthin and vitamin E are associated with decreased risk of cataract. Although reliable data from randomized trials are accumulating for vitamin E and other antioxidant vitamins, randomized trial data for lutein/zeaxanthin are lacking. Such information will help to clarify the benefits of supplemental use of lutein/zeaxanthin and provide the most reliable evidence on which to base public health recommendations for cataract prevention by vitamin supplementation.”

“Dietary Carotenoids, Vitamins C and E, and Risk of Cataract in Women – A Prospective Study”
William G. Christen, ScD; Simin Liu, MD; Robert J. Glynn, ScD; J. Michael Gaziano, MD; Julie E. Buring, ScD
Arch Ophthalmol. 2008;126(1):102-109.

Higher Cataract Rebate A Mirage, Australia

AMA President, Dr Andrew Pesce, said today that a ‘new schedule fee (rebate)’ for complex cataract surgery announced by the Health Minister was a mirage and that most Australians in need of cataract surgery will still be worse off as a result of the original Budget cut.

Dr Pesce said the new rebate of $850.75 for a complex cataract extraction of 40 minutes or more is an increase of just $19.15 (2.3 per cent) for existing item 42702, and will apply to a small minority of procedures.

“The great majority of cataract procedures are still subject to the harsh Budget cut,” Dr Pesce said.

“From 1 November, most Australians in need of cataract surgery will get only half the rebate that is available today for this sight-saving operation.

“The recent AMA survey of ophthalmologists showed that around 60 per cent of cataract procedures take between 21 and 39 minutes.

“Fewer than 12 per cent take more than 40 minutes, according to the survey.

“People seeking the surgery, many of them elderly, will be forced to pay more.

“The Government must realise that all cataract surgery is complex and that the doctors provide high-quality specialist care to every patient according to their individual needs and condition.

“The priority is the best quality outcome for the patient, not clock watching.

“The original rebate must be restored,” Dr Pesce said.

Australian Medical Association

National Survey Provides Important New Data About Blindness In Nigeria

A new survey of blindness and low vision in Nigeria of adults aged 40 and above has found that nearly half a million adults in Africa’s most populous country are in immediate need of cataract surgery.

Initiated by the Federal Ministry of Health, the survey was supported by Sightsavers International and provides important data which had previously been lacking about the number of people in Nigeria who are blind and visually impaired and the causes of their visual loss.

The survey indicates that 486,000 adults across the country are in immediate need of cataract surgery, a straightforward operation lasting a matter of minutes, which the World Bank has described as “one of the most cost-effective surgical interventions”. Other important causes of blindness were glaucoma (a condition in which the optic nerve is damaged, often by high pressure inside the eye), corneal scarring and poor procedures for cataract surgery. Onchocerciasis, or river blindness, and trachoma together accounted for five percent of blindness.

The survey found that almost half of all procedures for blinding cataract undergone by survey participants had been performed by herbalists (“couching”) and this was more common in the north of the country. During couching an instrument is used to dislocate the opaque lens away from the pupil, into the back of the eye but this is often associated with complications.

As in many developing countries, Nigeria suffers from a lack of trained staff and equipment to enable a significant reduction in the backlog of cataract operations. In this part of Africa, the number of ophthalmologists is less than one per million people.

Extrapolating the data from the survey to the total population, the prevalence of blindness in Nigeria is estimated to be 0.78%.

The survey’s other key preliminary findings are as follows:

– In Nigeria, over 1,000,000 adults are blind and another 3,000,000 are visually impaired

– 42 out of every 1000 adults aged 40 and above are blind

– Overall, two out of three Nigerians are blind from causes which could be avoided such as cataract which is the single commonest cause of blindness

– Blindness is almost three times more common in the dry northern areas (the Sahel) than in southern delta areas

– Illiterate participants were twice as likely to be blind as those who were literate

During the survey, information was also collected on non-communicable diseases such as diabetes, hypertension and obesity, and also on measures of development, such as access to safe water and sanitation, and levels of literacy.

Sightsavers has been working to prevent and cure blindness in Nigeria for over 40 years as well as support people who are permanently blind and visually impaired. According to the organisation’s representative in Nigeria, Dr Elizabeth Elhassan:

“Nigerians now account for one in five Africans and the survey indicates the growing and urgent need to increase access to eye care as well as the importance of reaching people who are illiterate.”

An additional benefit of the survey is that the findings are applicable to almost 100 million people who live in surrounding countries that share similar ecological zones to Nigeria such as Benin, Togo and Niger.

Professor Clare Gilbert from the International Centre for Eye Health and medical advisor to Sightsavers was closely involved with the survey. “The information from this national survey,” she said, “will prove invaluable in the planning of comprehensive eye services in Nigeria and elsewhere, from prevention and rehabilitation in the community through to tertiary level clinical services.”

As a direct result of the survey, over 3500 cataract operations were performed, 5800 pairs of reading glasses dispensed, more than 200 pairs of aphakic glasses distributed at no cost and thousands with minor ailments were treated.

1. The Nigerian National Survey of Blindness and Low Vision examined over 13,600 adults aged 40 years and over in 305 clusters across the country. Every state had at least three clusters. Over 5000 children aged 10-15 years were also examined. A total of 140 staff conducted the survey using the latest equipment, including visual field testing and digital photography. Field work took place between 2005 and 2007.

2. The survey was supported by Sightsavers International (UK), CBM (Germany), The Velux Stiftung (Switzerland), state governments and the FCT Abuja, local governments and the Federal Ministry of Health (Nigeria). Copies of the survey’s preliminary findings are available.

3. There are 45 million blind people in the world; 75% of all blindness can be prevented or cured.

4. Sightsavers International is a registered UK charity (number 207544 England & Wales, Scotland SC038110) that works in more than 30 developing countries to prevent blindness, restore sight and advocate for inclusion and equal rights for people who are blind and visually impaired.

Sightsavers International

International Recall Of 1 Day Acuvue Contact Lenses By Johnson & Johnson

1 Day Acuvue contact lenses have been recalled by Johnson & Johnson (J&J) in 24 countries, not including the USA or Canada, following reports of irritation, stinging and pain among some users. J&J described the incident as “an isolated issue in one portion of the lens rinsing process on a particular manufacturing line affecting a limited number of lots”. One of the substances used during manufacturing was not completely removed during the rinse, the company says.

The company believes the source of the problem is in the Republic of Ireland, where the product is produced.

The recall, which initially only affected Japan and some other Asian countries, is now extended to Australia, Germany, France, Russia, the United Kingdom, and Singapore.

This is J&J’s ninth recall of a consumer health product in one year.

J&J say that approximately 100,000 boxes are affected. Each box carries 30 or 90 lenses.

In an interview with The Associated Press, Gary Esterow, a J&J spokesperson, said:

The risk of long-term health consequences is very unlikely. In most instances, people put a lens in one eye, realized it was uncomfortable and took it out

Esterow added that the manufacturing equipment has been examined, and the cause of the problem has been corrected.

1-Day Acuvue TruEye, the world’s first daily disposable contact lens, is manufactured using a new breathable silicone hydrogel material – Narafilcon A – a new silicone hydrogel material saturated with a locked-in super smooth wetting agent. The lenses are designed to be worn only once, and are then discarded – so users do not have to be concerned about soaking solutions or lens cases.

Source: Johnson and Johnson, Associated Press

Why Light Worsens Migraine Headaches

Ask anyone who suffers from migraine headaches what they do when they’re having an attack, and you’re likely to hear “go into a dark room.” And although it’s long been known that light makes migraines worse, the reason why has been unclear.

Now scientists at Beth Israel Deaconess Medical Center (BIDMC) have identified a new visual pathway that underlies sensitivity to light during migraine in both blind individuals and in individuals with normal eyesight. The findings, which appear in the Advance On-line issue of Nature Neuroscience, help explain the mechanism behind this widespread condition.

A one-sided, throbbing headache associated with a number of symptoms, including nausea, vomiting, and fatigue, migraines are notoriously debilitating and surprisingly widespread, affecting more than 30 million individuals in the U.S. alone. Migraine pain is believed to develop when the meninges, the system of membranes surrounding the brain and central nervous system, becomes irritated, which stimulates pain receptors and triggers a series of events that lead to the prolonged activation of groups of sensory neurons.

“This explains the throbbing headache and accompanying scalp and neck-muscle tenderness experienced by many migraine patients,” explains the study’s senior author Rami Burstein, PhD, Professor of Anesthesia and Critical Care Medicine at BIDMC and Harvard Medical School.

In addition, for reasons that were unknown, nearly 85 percent of migraine patients are also extremely sensitive to light, a condition known as photophobia.

“Migraine patients may wear sunglasses, even at night,” he notes, adding that the dimmest of light can make migraine pain worse. Extremely disabling, photophobia prevents patients from such routine activities as reading, writing, working or driving.

It was the observation that even blind individuals who suffer from migraines were experiencing photophobia that led Burstein and first author Rodrigo Noseda, PhD, to hypothesize that signals transmitted from the retina via the optic nerve were somehow triggering the intensification of pain.

The investigators studied two groups of blind individuals who suffer migraine headaches. Patients in the first group were totally blind due to eye diseases such as retinal cancer and glaucoma; they were unable to see images or to sense light and therefore could not maintain normal sleep-wake cycles. Patients in the second group were legally blind due to retinal degenerative diseases such as retinitis pigmentosa; although they were unable to perceive images, they could detect the presence of light and maintain normal sleep-wake cycles.

“While the patients in the first group did not experience any worsening of their headaches from light exposure, the patients in the second group clearly described intensified pain when they were exposed to light, in particular blue or gray wavelengths,” explains Burstein. “This suggested to us that the mechanism of photophobia must involve the optic nerve, because in totally blind individuals, the optic nerve does not carry light signals to the brain.

“We also suspected that a group of recently discovered retinal cells containing melanopsin photoreceptors [which help control biological functions including sleep and wakefulness] is critically involved in this process, because these are the only functioning light receptors left among patients who are legally blind.”

The scientists took these ideas to the laboratory, where they performed a series of experiments in an animal model of migraine. After injecting dyes into the eye, they traced the path of the melanopsin retinal cells through the optic nerve to the brain, where they found a group of neurons that become electrically active during migraine.

“When small electrodes were inserted into these ‘migraine neurons,’ we discovered that light was triggering a flow of electrical signals that was converging on these very cells,” says Burstein. “This increased their activity within seconds.”

And even when the light was removed, he notes, these neurons remained activated. “This helps explain why patients say that their headache intensifies within seconds after exposure to light, and improves 20 to 30 minutes after being in the dark.”

The discovery of this pathway provides scientists with a new avenue to follow in working to address the problem of photophobia.

“Clinically, this research sets the stage for identifying ways to block the pathway so that migraine patients can endure light without pain,” adds Burstein.

In addition to Noseda and Burstein, coauthors include BIDMC investigators Vanessa Kainz, Moshe Jakubowski, Joshua Gooley, and Clifford B. Saper; and Kathleen Digre of the University of Utah.

This study was funded by grants from the National Institutes of Health and from the Research to Prevent Blindness.

Bonnie Prescott

Beth Israel Deaconess Medical Center

Guide Dogs Publishes First Ever Guide To Services And Support For Blind And Partially Sighted People In The UK

Blind and partially sighted people across the UK will benefit from a unique directory of the services available to them, published by Guide Dogs. The guide has been produced by the charity in support of the UK Vision Strategy. The comprehensive guide gives blind and partially sighted people, and their families and carers, a way to quickly and easily find out what social, health and rehabilitation services and support from voluntary groups is available in their area. Organisations and professionals who support people with sight loss can use it to signpost their clients to helpful services.

Katherine Harrison, who provides information on services to blind and partially-sighted people in her area, and is visually-impaired herself, said: “For someone diagnosed with sight loss, the information in this guide could give them just what they were looking for to get started. I can see that it might be the starting point of a very exciting journey.”

Published in sections by UK region, with hyperlinked contents pages, the guide is available to access online via the Guide Dogs website and also from a link on the UK Vision Strategy website. This enables people to reach the information and contact details they need in just a few clicks.

The Guide to Services for Blind and Partially Sighted People supports Guide Dogs’ new strategy, which is centred on the mobility journey – empowering blind and partially-sighted people to get where they want to be.

Bridget Warr, Guide Dogs’ chief executive, said: “The journey through sight loss can be difficult and frustrating. The anxiety and loss of confidence many people experience around the time of diagnosis can prevent them moving on to live a full, independent life. Knowing what support is available, and how to access it, can make all the difference. This guide aims to improve awareness of and access to services – and therefore outcomes for individuals. It will also provide useful information for a whole range of organisations in referring people on and in planning their own services.”

The document has hyperlinked contents pages, and is available in JAWS-friendly Word format, ensuring that blind and partially-sighted people can easily access it. Copies of the guide will also be made available on CD ROM for people who do not have access to the internet.

Angela Tinker, chief executive of Visionary – linking local sight loss charities (previously NALSVI – National Association of Local Societies for Visually Impaired People), said: “This guide will really help visually-impaired people, their families and carers directly. It will also help local charities to help them more easily too.”

Guide Dogs commissioned this Guide to Services as part of its commitment and contribution to the UK Vision Strategy, which has three aims: to improve eye health in the UK; to eliminate avoidable sight loss; and to ensure blind and partially sighted people are integrated in all aspects of society.

About Guide Dogs

Guide Dogs, the working name for The Guide Dogs for the Blind Association, was founded in 1934 to help blind and partially sighted people enjoy the same freedom of movement as everyone else.

The charity receives no government funding and relies on voluntary and legacy income.

In 2009 Guide Dogs produced 760 guide dog partnerships, with the lifetime cost of a guide dog from birth to retirement being ??49,800.

The charity also funds ophthalmic research, provides other mobility services including white cane training, and campaigns to break down legal and physical barriers to help blind and partially-sighted people get around independently.

Registered charity number 209617 / SC038979


Age Related Macular Degeneration: New Genetic Association Identified

A team of clinicians and scientists at the University of Southampton has identified a major new genetic association with age-related macular degeneration, the most common cause of blindness in developed countries.

Their research, which is published online in The Lancet, adds to the growing understanding of the genetics of age-related macular degeneration and they believe it will better help predict those at risk and ultimately lead to better treatments.

The team, including Professor Andrew Lotery and his research group in the University’s Clinical Neurosciences Division, together with Dr Sarah Ennis and Professor Andy Collins from the Genetic Epidemiology and Bioinformatics Group in the University’s Human Genetics Division, found an association with the SERPING1 gene, which is involved in production of proteins for the ‘complement’ system within the eye, which helps clear foreign material and infection.

Together with colleagues from the University of Iowa, they found evidence of proteins expressed by SERPING1 in the retina and the choroid layer (the vascular layer next to the retina), the two areas affected by AMD. The findings suggest that the complement system is malfunctioning, attacking the retina and choroid layer.

Andrew Lotery, Professor of Ophthalmology at the University, comments: “Our study also shows that a particular variant of the gene SERPING1, carried by just under a quarter of the population, appears to offer protection against the disease.

“I am delighted that researchers at the University of Southampton have made such an important contribution to understanding this devastating disease. Now we must take this research further to ensure patients get maximum benefit from this discovery.”

Almost two-thirds of people aged 80 years or older are affected by AMD to some degree, with more than one in ten left blind by the disease. In the UK, the annual economic burden from the disease has been estimated to be as high as ??80 million, a figure set to increase as our ageing population expands. The total yearly costs of health-care usage are seven-times higher for patients with AMD than for those unaffected.

This research was supported by the Macula Vision Research Foundation, the Macular Disease Society, the Wellcome Trust, Brian Mercer Trust, the American Health Assistance Foundation, the National Institutes of Health and the Howard Hughes Medical Institute.

Professor Lotery’s work in researching eye disease is supported by a specific charity called The Gift of Sight Appeal giftofsight, which is administered by the Development Office at the University of Southampton.

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