Posts Tagged ‘seniors’

Why Aging Eyes Struggle To Discern Fine Print

January 22nd, 2013

Psychologists from the University of Leicester have carried out unique eye tests to examine reading styles in young and old people – and discovered for the first time that the way we read words changes as we grow older.

The team from the School of Psychology used an innovative method of digitally manipulating text combined with precise measures of readers’ eye movements. This provides novel insights into how young and older adults use different visual cues during reading.

Their results have been published in the journal Psychology and Aging.

The researchers conducted experiments that used very precise measures of readers’ eye movements to assess how well they read lines of text that had been digitally manipulated to enhance the salience of different visual information. For instance, sometimes the text was blurred and other times the features of the individual letters were sharply defined.

A volunteer using an EyeLink 2000 eye-tracker.

The results showed that whereas young adults (18-30 years) found it easiest to read lines of text when the fine visual detail was present, this was more difficult for older adults (65+years), who found it easier to read more blurred text. These findings support the view that older adults use a different reading strategy from younger adults and that they rely more than young adults on holistic cues to the identities of words, such as word shape.

The research makes an important contribution to understanding why older people have difficulty in reading. The findings will promote further work to more fully understand this difficulty and already points to ways in which it can be combatted.

Dr Kevin Paterson, from the University of Leicester, said: “The findings showed that the difficulty older readers often experience is likely to be related to a progressive decline in visual sensitivity, particularly for visual detail, due to optical changes and changes in neural transmission even in individuals with apparently normal vision.

“However, the findings also showed that older readers comprehended text just as accurately as younger readers. Consequently, although normal aging clearly leads to important changes in reading behaviour, it seems that adaptive responses to the changing nature of the visual input may help older adults to read and understand text efficiently well into later life.”

Dr Kevin Paterson

The research study aimed to understand how changes that take place in the eye and brain as a result of the normal aging process affect reading.

Dr Paterson said: “As we get older, we lose visual sensitivity, particularly to fine visual detail, due to changes in the eye and changes in neural transmission. This loss of visual sensitivity is found even in individuals with apparently normal vision and is not corrected by optical aids, such as glasses or contact lenses. However, it is likely to have consequences for reading.

“The ability to read effectively is fundamental to participation in modern society, and the challenge age-related visual impairment presents to meeting everyday demands of living, working and citizenship is a matter of concern. The difficulty older adults have in reading is an important contributing factor to social exclusion. The RNIB has identified age-related reading difficulty amongst the over 65s as highly detrimental to quality of life and a barrier to employment.

“The fact that people have greater difficulty in reading as they get older limits their ability to engage in everyday activities (e.g., reading the newspaper, a utility bill, or the instructions on a medicine bottle), to continue to work, to read for leisure, to access education and knowledge, and to interact with others. Being able to understand the causes of this reading difficulty is an important first step to identifying ways to combat it.

“With an aging population and a rising retirement age, it is clear such problems pose serious economic and social challenges for the future. Consequently, research on this topic is likely to become increasingly important and both understanding and combatting age-related visual impairment will be important for reducing social exclusion in the elderly.

www2.le.ac.uk

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Eye Doctors Must Do More To Spot Unsafe Older Drivers

December 17th, 2012

Most eye doctors consider it their responsibility to ask older patients about driving problems, but this hit-or-miss approach may not be nearly enough to clear the roads of unsafe elderly drivers, new research suggests.

By 2020, as the U.S. population ages, the number of drivers over age 65 will reach 40 million, according to the study. Many will have failing vision, reduced mobility and perhaps cloudy thinking, thus posing a serious public health issue, the researchers said.

For two new studies, researchers surveyed more than 400 ophthalmologists and optometrists in Michigan with patients older than 65. The researchers asked the doctors for their views on whether to ask patients about driving, how to decide if a patient’s vision is inadequate and whether they referred patients to primary care physicians.

David C. Musch, Ph.D., M.P.H.

“We were pleased to see a high response” of vision care providers who ask about driving, said David Musch, a professor of ophthalmology and visual sciences at the University of Michigan, and lead author and co-author of the studies.

The eye specialists, however, did not usually refer patients they were concerned about to primary care physicians, who are better equipped to assess thinking and physical ability and how they could affect safe driving, Musch said.

And providers rarely asked about common driving situations, such as making left turns, that might also reflect driving ability, the survey found.

Age-related changes in eyesight along with declines in mental and physical abilities can hamper driving ability. Some states, including Florida, Oregon and Virginia, require eye exams for older people who want to renew their driver’s license. But they don’t usually have criteria for other disabilities such as arthritis that could limit a driver’s range of motion, for example.

Fifteen percent of all licensed U.S. drivers in 2007 were 65 and older, according to the National Highway Traffic Safety Administration. Automobile accidents are a leading cause of injury-related death in people aged 65 to 74.

The studies, published Oct. 8 in the journal Archives of Ophthalmology, found the following:
In 87 percent of cases, participants said they would always or often inquire about driving ability if a patient did poorly on an eye exam. Other common reasons were if a patient or family member asked about a driving problem.

Two thirds of survey respondents said they ask all older patients about driving ability.
Although most said they always or often asked about night driving, glare and reading signs — common challenges for older drivers — less than 10 percent also asked about making left turns, merging and backing up, which are potential downfalls for poor-sighted drivers.

Less than 30 percent of providers said they asked about driving after noticing a problem other than visual impairment.

More than half of the eye specialists said they were reluctant to report unsafe drivers to regulatory agencies, because this could undermine the doctor-patient relationship. Some also worried about liability issues.

The survey also revealed that only about 36 percent and 28 percent of vision care providers, respectively, referred their patients to primary care physicians or driving rehabilitation always, often or sometimes.

Communication between eye doctors and primary care doctors is essential in this process, Musch said.

In many cases, driving rehab can help older patients stay on the road longer, said Patrick Baker, a driver rehabilitation therapist at Cleveland Clinic. For example, driving specialists can add mirrors to the car of someone with limited neck rotation or talk with people with mild cognitive impairment and their caregivers about avoiding traffic and night driving.

Barbara Messinger-Rapport, M.D., Ph.D.

Dr. Barbara Messinger-Rapport, director of the Center for Geriatric Medicine at Cleveland Clinic, believes eye care providers have a duty to put the brakes on drivers with visual impairment.

They “should ask each patient over the age of 75 if they’re driving, and if their visual acuity and peripheral vision [the two legally required tests] are not within the licensing requirements for their state, they should inform the patient,” she said.

How providers assess vision in the first place may also need improvement. Nearly all providers test visual acuity, in which patients read smaller and smaller letters, and peripheral vision, but there is not strong evidence for how these tests relate to safe driving, Musch said.

Tests like contrast sensitivity could improve the assessment of safe driving, some say. The contrast test is similar to the visual acuity test except patients have to read letters that are gray, instead of black, on a white background.

Baker said he wishes doctors would test contrast sensitivity more often.

“You don’t need to be able to read the license plate in front of you, you need to be able to tell if it’s a car in front of you or a shadow or some other object,” he said.

To learn more about driving safety, visit the U.S. National Highway Traffic Safety Administration.

By Carina Storrs
HealthDay Reporter

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Debilitating Eyesight Problems Are On The Decline For Older Americans

July 30th, 2012

Today’s senior citizens are reporting fewer visual impairment problems than their counterparts from a generation ago, according to a new Northwestern Medicine study. Improved techniques for cataract surgery and a reduction in the prevalence of macular degeneration may be the driving forces behind this change, the researchers said.

“From 1984 until 2010, the decrease in visual impairment in those 65 and older was highly statistically significant,” said Angelo P. Tanna, M.D., first author of the study. “There was little change in visual impairments in adults under the age of 65.”

The study, published in the journal Ophthalmology, shows that in 1984, 23 percent of elderly adults had difficulty reading or seeing newspaper print because of poor eyesight. By 2010, there was an age-adjusted 58 percent decrease in this kind of visual impairment, with only 9.7 percent of elderly reporting the problem.

Angelo P. Tanna, M.D.

There was also a substantial decline in eyesight problems that limited elderly Americans from taking part in daily activities, such as bathing, dressing or getting around inside or outside of the home, according to the study.

“The findings are exciting, because they suggest that currently used diagnostic and screening tools and therapeutic interventions for various ophthalmic diseases are helping to prolong the vision of elderly Americans,” Tanna said.

Tanna is the vice chairman of ophthalmology at Northwestern University Feinberg School of Medicine and an attending physician at Northwestern Memorial Hospital. Stephen Kaye, of the Institute for Health & Aging and Disability Statistics Center, University of California, is the second author of the study.

The study used self-reported data collected from 1984 to 2010 through two major population-based surveys, the National Health Interview Survey and the Survey of Income and Program Participation.

Survey questions revealed how vision problems can impact the daily activities and quality of life of Americans and helped researchers analyze trends in the prevalence of visual impairment of adults in the United States.

While this study didn’t identify any of the causes of the change in the prevalence of visual impairment, Tanna said there are three likely reasons for the decline:

  • Improved techniques and outcomes for cataract surgery
  • Less smoking, resulting in a drop in the prevalence of macular degeneration
  • Treatments for diabetic eye diseases are more readily available and improved, despite the fact that the prevalence of diabetes has increased

Future studies should identify which treatment strategies help prevent vision loss in older adults and then make those treatments available to as many people as possible, Tanna said.

This study was funded by a grant from Research to Prevent Blindness and by the National Institute on Disability and Rehabilitation Research, US Department of Education (grant H133B080002).

feinberg.northwestern.edu

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Kellogg Researcher Helping Eye Care Providers Better Assess Driving in Older Adults

September 13th, 2011

Drivers over age 65 are the fastest-growing segment of the driving population, and their eye care providers—ophthalmologists and optometrists—are playing an increasingly important role in assessing their ability to drive safely.

David C. Musch, Ph.D., M.P.H.

Kellogg researcher David C. Musch, Ph.D., M.P.H., recently led a multidisciplinary University of Michigan (U-M) study team, which was supported by a grant from M-CASTL, a unit of the U-M Transportation Research Institute, who surveyed how 500 vision care providers in Michigan assess the driving capabilities of their senior patients.

Dr. Musch and his team found that the majority of eye care providers feel it’s their responsibility to ask senior patients about driving, and most do it routinely. They test visual acuity and peripheral vision but often fail to ask about other factors—such as medical conditions or medications—that might affect the ability to drive. Inquiries about glare, driving at night and reading signs were very common (87 percent) but questions about challenging driving situations—merging or backing up—or the patient’s driving record were very infrequent (8 percent).

Many eye care providers (81 percent) stress that certain resources—driving assessment guidelines, clinical screening instruments and a patient self-evaluation tool—would help them in assessing the driving capabilities of their senior patients, and help to address higher accident rates for older drivers.

“We’ve identified a need and a desire on the part of vision care professionals to help,” says Dr. Musch, who cites research indicating that when seniors lose the ability to drive, there are consequences. These individuals have higher rates of depression and social isolation, more limited access to health care services, and are more likely to need long-term care. “Our goal is to intervene and work with our patients in modifying their driving habits. This will allow them to drive appropriately and maintain their independence,” he says.

While most eye care providers feel confident in their ability to determine whether vision is adequate for safe driving, few consider themselves the most-qualified professional to identify unsafe drivers. Only a small number of eye care providers (8 percent) communicate driving concerns with the patient’s primary care physician or refer patients to driving rehabilitation specialists or driving school. And, when asked about reporting unsafe drivers, some common concerns were negative impact on the doctor-patient relationship, liability issues, doctor-patient confidentiality and patient’s quality of life

Still, eye care providers are among the most important professionals in seniors’ health care, and they need to be on the lookout for seniors who may need special attention, says Dr. Musch. Identifying and providing effective resources to eye care providers to aid them in evaluating and assisting patients is the next step in the process, he adds.

www.kellogg.umich.edu

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Stem Cell Therapy for Age-Related Macular Degeneration a Step Closer to Reality

April 1st, 2011

The notion of transplanting adult stem cells to treat or even cure age-related macular degeneration has taken a significant step toward becoming a reality. In a study published in Stem Cells, Georgetown University Medical Center researchers have demonstrated, for the first time, the ability to create retinal cells derived from human-induced pluripotent stem cells that mimic the eye cells that die and cause loss of sight.

Age-related macular degeneration (AMD) is a leading cause of visual impairment and blindness in older Americans and worldwide. AMD gradually destroys sharp, central vision needed for seeing objects clearly and for common daily tasks such as reading and driving. AMD progresses with death of retinal pigment epithelium (RPE), a dark color layer of cells which nourishes the visual cells in the retina.

While some treatments can help slow its progression, there is no cure. The discovery of human induced pluripotent stem (hiPS) cells has opened a new avenue for the treatment of degenerative diseases, like AMD, by using a patient’s own stem cells to generate tissues and cells for transplantation.

For transplantation to be viable in age-related macular degeneration, researchers have to first figure out how to program the naïve hiPS cells to function and possess the characteristics of the native retinal pigment epithelium, RPE, the cells that die off and lead to AMD.

The research conducted by the Georgetown scientists shows that this critical step in regenerative medicine for AMD has greatly progressed.

“This is the first time that hiPS-RPE cells have been produced with the characteristics and functioning of the RPE cells in the eye. That makes these cells promising candidates for retinal regeneration therapies in age-related macular degeneration,” says the study’s lead author Nady Golestaneh, Ph.D., assistant professor in GUMC’s Department of Biochemistry and Molecular & Cellular Biology.

Using an established laboratory stem cell line, Golestaneh and her colleagues show that RPE generated from hiPS cells under defined conditions exhibit ion transport, membrane potential, polarized VEGF secretion and gene expression profile similar to those of a normal eye’s RPE.

“This isn’t ready for prime time though. We also identified some issues that need to be worked out before these cells are ready for transplantation but overall, this is a tremendous step forward in regenerative medicine,” Golestaneh adds.

She explains that the hiPS-derived RPE cells show rapid telomere shortening, DNA chromosomal damage and increased p21 expression that cause cell growth arrest. This might be due to the random integration of viruses in the genome of skin fibroblasts during the reprogramming of iPS cells. Therefore, generation of viral-free iPS cells and their differentiation into RPE will be a necessary step towards implementation of these cells in clinical application, Golestaneh says.

“The next step in this research is to focus on a generation of ‘safe’ as well as viable hiPS-derived somatic cells,” Golestaneh concludes.

Other authors on the paper include first author Maria Kokkinaki, Ph.D., Department of Biochemistry and Molecular &Cellular Biology, and Niaz Sahibzada, Ph.D., Department of Pharmacology at GUMC.

About Georgetown University Medical Center

Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through MedStar Health). GUMC’s mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Georgetown Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO). In fiscal year 2009-2010, GUMC accounted for 79 percent of Georgetown University’s extramural research funding.

gumc.georgetown.edu

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This Holiday Season EyeCare America Asks Seniors, “Do You See What I See?”

December 20th, 2010
National Non-Profit Provides Eye Exams at No Cost to Eligible Patients

“Do You See What I See?” For seniors who suffer with eye disease the answer is always, “No.”

This holiday season, EyeCare America has launched a campaign called, “Do You See What I See?” The campaign aims to connect eligible seniors with sight-saving eye exams and eye health information. EyeCare America’s year-round program provides eye exams at no out-of-pocket cost to people age 65 and older and offers free educational materials. The eye exams will be provided by nearly 7,000 volunteer ophthalmologists across the U.S. Those interested in the program can visit http://www.eyecareamerica.org to see if they are eligible. The organization’s online referral center also enables friends and family members to find out instantly if their loved ones are eligible to be matched with an EyeCare America volunteer ophthalmologist.

“Early detection and treatment can decrease the chances of permanent vision loss and slow the progression of eye disease,” said Richard P. Mills, M.D., Chair of EyeCare America. “The entire process was a pure gift. Heartfelt gratitude to your staff. Thank you for this tremendously good service,” said Mary Kelly, an EyeCare America patient from CA.

EyeCare America bridges the healthcare gap for the aging U.S. population. Through this service, those who are eligible receive a dilated medical exam and up to one year of care at no out-of-pocket cost. EyeCare America is able to provide this no cost care through its network of volunteer ophthalmologists who waive patient co-payments and accept Medicare as payment in full for their services. Eligible patients without insurance are not charged.

EyeCare America is designed for people who:

  • Are U.S. citizens or legal residents
  • Are age 65 and older
  • Have not seen an ophthalmologist in three or more years
  • Do not receive eye care through an HMO or the VA

To see immediately if you, a loved one or a friend, 65 and older, is eligible to receive a referral for an eye exam and care, visit http://www.eyecareamerica.org.
EyeCare America is co-sponsored by the Knights Templar Eye Foundation, Inc., with additional support provided by Alcon. The program is endorsed by state and subspecialty ophthalmological societies.

About EyeCare America

Established in 1985, EyeCare America, the public service program of the Foundation of the American Academy of Ophthalmology, is committed to the preservation of sight, accomplishing its mission through public service and education. EyeCare America provides eye care services to medically underserved seniors and those at increased risk for eye disease through its corps of 7,000 volunteer ophthalmologists dedicated to serving their communities. More than 90 percent of the care made available is provided at no out-of-pocket cost to the patients. Since its inception, EyeCare America has helped more than 1.5 million people. EyeCare America is a non-profit program whose success is made possible through charitable contributions from individuals, foundations and corporations. More information can be found at: http://www.eyecareamerica.org

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Bausch & Lomb to Feature Actress Florence Henderson in Crystalens National Advertising Campaign

September 30th, 2010

Bausch & Lomb, the global eye health company, said it will work with Broadway, film and TV actress Florence Henderson in an integrated marketing campaign starting this fall for its Crystalens approved accommodating intraocular lens (IOL).

Henderson will share her experiences as a Crystalens patient in local television, national print and online advertising. She is best known for her role as Carol Brady in the iconic television series “The Brady Bunch,” which ran on network television from 1969 to 1974 and continues in syndication today. She has enjoyed a storied entertainment career that has spanned five decades.

 

The Crystalens is the only FDA-approved accommodating intraocular lens. The marketing and advertising program will feature Henderson talking about what it is like to have a cataract, how cataracts adversely affected her vision and what life has been like since she had her Crystalens surgery. It will emphasize that the Crystalens not only corrects the cataract but also provides a full range of vision.

“We are thrilled to be working with Florence Henderson,” said Amy Jacobs, director, global marketing, for Crystalens. “It is already proving to be a great partnership because she embodies the Crystalens brand with her very active lifestyle. She is a proven, effective spokesperson who has great influence with the 50 years and older audience. Her experience as a Crystalens patient heightens her already considerable credibility with our surgeons and their potential patients.”

An estimated 20 million aging Baby Boomers and seniors have cataracts. Approximately three million cataract surgeries are performed in the U.S. every year.

“When something works for me like Crystalens has, I like to share my experience. I am happy when telling my story helps empower, inspire and motivate people to take care of themselves. It is important for people over 50 to understand what a cataract is and what they can do about it,” said Henderson.

crystalens.com

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Muffins and Bread Show Lutein Carrier Potential for Eye Health

September 14th, 2010

Fortifying bread and muffins with lutein may be a suitable vehicle to boost intakes of the compound, according to a new study from Spain.

High-lutein wheat and corn flour was used to prepare lutein enriched cookies, muffins and bread, with “reasonable amounts” of the carotenoid still measurable in the final baked products, according to results published in the Journal of Agricultural and Food Chemistry.

“Despite the significant losses of lutein during processing, the developed fortified baked products still contain reasonable concentrations (up to 1.0 mg/serving) of lutein and would hold promise for the development of high-lutein functional foods,” wrote researchers from Guelph Food Research Centre, Agriculture and Agri-Food Canada.

All Eyes On Lutein

Lutein, a nutrient found in various foods including green leafy vegetables and egg yolk, has a ten-year history in the dietary supplement market as a nutrient to reduce the risk of age related macular degeneration (ADM).

The global lutein market is set to hit $124.5 million (€93 million) in 2013, according to a 2007 report from Frost & Sullivan, with skin health offering a major new avenue for the carotenoid.

According to the report, manufacturers need to address this growing maturity in dietary supplements by identifying new and potentially lucrative application segments that offer opportunities for the continued growth of the lutein market.

“Because the role of lutein in human health has become evident, it is essential to boost the daily intake of lutein, which is low worldwide. For example, the average daily intake of lutein in the United States is about 1.7mg/day and in Europe is 2.2 mg/day,” wrote the researchers, led by El-Sayed Abdel-Aal and his co-workers.

“These values are below the levels purported to reduce the risk of eye diseases such as cataracts and AMD […] Thus, the development of high-lutein staple foods would be of interest to the food industry to enhance lutein intake,” they added.

Study Details

The Guelph-based researchers prepared pan bread, flat bread, cookies, and muffins were with high-lutein and lutein-fortified whole wheat flours. Processing and baking detrimentally affected the lutein and zeaxanthin content of the bakery products. For example, in the flat bread the all-trans lutein decreased by about 40 per cent, while the reduction in cookies was about 63 percent. The loss in muffins was similar, with about 58 percent of the trans-lutein lost.

Despite such losses the researchers were positive about the potential of fortified bakery to offer lutein-rich products.

Next stage

The researcher confirmed that further study is already underway, with the focus on “how much lutein is transferred from the food matrix into the bile acid micelles and how much lutein is absorbed/passes through intestinal walls”, wrote Abdel-Aal and his co-workers.

“In addition, more research is being carried out to evaluate antioxidant properties of these wholegrain high-lutein food products,” they added.

by Stephen Daniells
nutraingredients-usa.com

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NASA Testing Adjustable Liquid-Lens Eyeglasses for Space

August 21st, 2010

When our vision starts fading, glasses or contact lenses (or laser surgery!) are a simple cure.

But for NASA astronauts working in the near weightlessness of a space environment, it’s not that easy.

After all, they’re trying to read from all sorts of angles. And many of them are middle-aged and facing presbyopia, that classic “Mom needs reading glasses” condition. Adding insult to injury, the microgravity environment actually helps degrade vision.

So what’s an astronaut to do? Larry Greenmeier in Scientific American details a solution called TruFocals, a new type of adjustable eyeglass lens that NASA has been testing for use in space.

Made by Van Nuys, Calif.–based Zoom Focus Eyewear (and sold for $900 per pair, retail), the three millimeter-thick, flexible lenses can change their focus on the fly.

Greenmeier describes how they work:

Each TruFocals lens—about three millimeters thick—actually consists of two magnetically attached lenses. The lens closer to the eye is flexible, with a transparent distensible (expandable) membrane attached to a clear rigid surface. The space between the membrane and the clear rigid surface holds a small amount of clear silicon fluid. A sliding lever on the bridge of the eyeglasses is used to push the fluid forward to alter the shape of the membrane and, by extension, the flexible lens. TruFocals for people with more advanced presbyopia contain more fluid than those made for people with a milder form of the condition. The second, outer lens features the wearer’s normal prescription.

In other words, the flexible lens replaces the eye’s eroding natural ability. That’s important because much of what NASA astronauts do — use complex equipment, read checklists and overhead instrument panels, etc. — is difficult to do with conventional eyeglasses, which have a small corrective zone.

And astronauts aren’t getting any younger, either.

NASA says its plan is to roll adjustable glasses out for use on the next space mission, either from Zoom Focus or Roanoke, Va.-based PixelOptics, which makes electronic adjustable lenses called emPower!.

Now all the astronauts will have to do is figure out how to make Harry Potter-style round lenses stylish.

by Andrew Nusca
smartplanet.com

trufocals.com

FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD Patients

July 19th, 2010

The U.S. Food and Drug Administration announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times.

AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

“This innovation has the potential to provide many people with an improved quality of life,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

U.S. Food and Drug Administration