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The FDA Approves Lucentis for the Treatment of Diabetic Retinopathy

retina with diabetic retinopathy

A retina with diabetic
retinopathy

On April 17, 2017, the United States Food and Drug Administration (FDA) granted approval to the injectable drug Lucentis (generic name ranibizumab) for the treatment of proliferative diabetic retinopathy (PDR), a serious vision-related complication of diabetes.

Previously, the FDA approved Lucentis for the treatment of diabetic macular edema (DME), a buildup of fluid in the macula, the center of the retina. Thus, with this latest treatment advance and FDA approval, physicians can use Lucentis to manage diabetic retinopathy in people with or without diabetic macular edema.

Important Background On this Research from The Journal of the American Medical Association

Results from an important clinical trial revealed that the injectable drug Lucentis is highly effective in treating proliferative diabetic retinopathy, a serious vision-related complication of diabetes.

The research, titled Panretinal Photocoagulation [i.e., laser treatment] vs Intravitreous Ranibizumab [i.e., Lucentis injection] for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial, was published online as an open-source article in the November 13, 2015 edition of The Journal of the American Medical Association and was timed to coincide with a presentation by the study authors at the 2015 Annual Meeting of the American Academy of Ophthalmology. The authors are the members of the Writing Committee for the Diabetic Retinopathy Clinical Research Network.

The Diabetic Retinopathy Clinical Research Network (DRCR.net) is a collaborative research group that supports the identification, design, and implementation of multi-center clinical research studies focused on diabetes-related eye and retinal disorders, including diabetic retinopathy and diabetic macular edema. The DRCR.net was formed in September 2002 and currently includes over 115 participating sites with over 400 physicians throughout the United States. It is funded by the National Eye Institute (NEI).

"These findings," said Dr. Paul Sieving, Director of the National Eye Institute (NEI), "provide crucial evidence for a safe and effective alternative to laser therapy against proliferative diabetic retinopathy." The clinical trial was funded by NEI, which described Lucentis as the first major advance in therapy for proliferative diabetic retinopathy in nearly 40 years. Although longer-term follow-up will be needed, Lucentis may provide a reasonable treatment alternative, at least through two years, for persons with proliferative diabetic retinopathy.

About Diabetic Eye Disease and Diabetic Retinopathy

Although people with diabetes are more likely to develop cataracts at a younger age and are twice as likely to develop glaucoma as people who do not have diabetes, the primary vision problem caused by diabetes is diabetic retinopathy, the leading cause of new cases of blindness and low vision in adults aged 20-65:

NEI example of seeing with diabetic retinopathy: many blind spots and overall blurriness

What a person with diabetic retinopathy sees

  • "Retinopathy" is a general term that describes damage to the retina.
  • The retina is a thin, light-sensitive tissue that lines the inside surface of the eye. Nerve cells in the retina convert incoming light into electrical impulses. These electrical impulses are carried by the optic nerve to the brain, which interprets them as visual images.
  • Diabetic retinopathy occurs when there is damage to the small blood vessels that nourish tissue and nerve cells in the retina.
  • "Proliferative" is a general term that means to grow or increase at a rapid rate by producing new tissue or cells. When the term "proliferative" is used in relation to diabetic retinopathy, it describes the growth, or proliferation, of abnormal new blood vessels in the retina. "Non-proliferative" indicates that this process is not yet occurring.
  • Proliferative diabetic retinopathy affects approximately 1 in 20 individuals with the disease.

Four Stages of Diabetic Retinopathy

According to the National Eye Institute, diabetic retinopathy has four stages:

  • Mild non-proliferative retinopathy: At this early stage, small areas of balloon-like swelling occur in the retina's tiny blood vessels.
  • Moderate non-proliferative retinopathy: As the disease progresses, some blood vessels that nourish the retina become blocked.
  • Severe non-proliferative retinopathy: Many more blood vessels become blocked, which disrupts the blood supply that nourishes the retina. The damaged retina then signals the body to produce new blood vessels.
  • Proliferative retinopathy: At this advanced stage, signals sent by the retina trigger the development of new blood vessels that grow (or proliferate) in the retina and the vitreous, which is a transparent gel that fills the interior of the eye. Because these new blood vessels are abnormal, they can rupture and bleed, causing hemorrhages in the retina or vitreous. Scar tissue can develop and can tug at the retina, causing further damage or even retinal detachment.

In addition, fluid can leak into the macula, the small sensitive area in the center of the retina that provides detail vision. This fluid can cause macular edema (or swelling), which can occur at any stage of diabetic retinopathy, although it is more likely to occur as the disease progresses.

Lucentis: An Anti-Angiogenic Drug to Treat Retinal Bleeding

Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue. Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and retinal disease.

Substances that stop the growth of these excessive blood vessels are called anti-angiogenic (anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels).

The focus of current anti-angiogenic drug treatments for retinal disease is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs are classified as anti-VEGF treatments and are administered by injection directly into the eye after the surface has been numbed.

At present, these anti-VEGF drugs (Lucentis, Avastin, and Eylea) require monthly injections or a pro re nata [meaning "as needed"] (PRN) regimen, with monthly controls and injections for recurrent or persistent blood vessel growth and retinal bleeding.

More about Lucentis and Diabetic Retinopathy Research

Excerpted from Lucentis proves effective against proliferative diabetic retinopathy, via Science Codex:

A clinical trial among more than 300 patients has found that the drug ranibizumab (Lucentis) is highly effective in treating proliferative diabetic retinopathy (PDR), a complication of diabetes that can severely damage eyesight. The results demonstrate the first major therapy advance for the condition in nearly 40 years.

The trial compared Lucentis injections with a type of laser therapy called panretinal photocoagulation, which has remained the gold standard for PDR since the mid-1970s. Although laser therapy preserves central vision, it can damage night and side vision, so researchers have sought therapies that lack these side effects.

"Patients who received Lucentis showed a little bit better central vision, much less loss of their side vision, and substantially less risk for surgery than patients who received laser treatment," said Lloyd Paul Aiello, M.D., Ph.D., director of the Beetham Eye Institute at Joslin Diabetes Center and Professor of Ophthalmology at Harvard Medical School. "These findings will change the available treatment options for patients with PDR."

The DRCR.net enrolled 305 participants (394 eyes) with PDR in one or both eyes at 55 clinical sites across the country. Eyes were assigned randomly to treatment with Lucentis or laser. About half of the eyes assigned to the laser group required more than one round of laser treatment. In the other group, Lucentis was injected into the eye once per month for three consecutive months, and then as needed until the disease resolved or stabilized.

Because Lucentis is commonly injected to treat diabetic macular edema (DME) – a build-up of fluid in the center of the retina – the study permitted the use of Lucentis for DME in the laser group, if necessary. Slightly more than half (53 percent) of eyes in the laser group received Lucentis injections to treat DME. About 6 percent of eyes in the Lucentis group received laser therapy, mostly for issues other than DME.

At two years, vision in the Lucentis group improved by an average of about half a line on an eye chart, compared with virtually no change in the laser group. Participants treated with laser generally lost substantial peripheral vision, but those given injections did not. Additionally, the need for vitrectomy surgery was lower in the Lucentis group (8 of 191 eyes) than in the laser group (30 of 203 eyes).

Overall, the drug's benefits are particularly clear for people with both PDR and DME. "We know that this drug will help treat both conditions at the same time, so this is an especially appealing treatment alternative for these patients," Dr. Aiello noted.

The study also suggested that Lucentis may help prevent DME. Among people without this condition at the start of the study, only 9 percent of Lucentis-treated eyes developed it, compared with 28 percent in the laser group. Scientists will follow up on that result as the DRCR.net continues to track patients for a total of five years.

More about the Study from The Journal of the American Medical Association

Excerpted from the article abstract, with the full article available online:

Importance: Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME).

Objective: To evaluate the non-inferiority of intravitreous ranibizumab [i.e., Lucentis injections] compared with [laser] for visual acuity outcomes in patients with proliferative diabetic retinopathy.

Design, Setting, and Participants: Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015.

Interventions: Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n=203 eyes), or [Lucentis], 0.5 mg, by intravitreous [i.e., within the eye] injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n=191 eyes). Eyes in both treatment groups could receive [Lucentis] for DME.

Main Outcomes and Measures: The primary outcome was mean visual acuity change at 2 years (5-letter non-inferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization.

Results: Mean visual acuity letter improvement at 2 years was +2.8 in the [Lucentis] group vs +0.2 in the PRP group. The mean treatment group difference in visual acuity area under the curve over 2 years was +4.2. Mean peripheral visual field sensitivity loss was worse, vitrectomy was more frequent, and DME development was more frequent in the [laser] group vs the [Lucentis] group, respectively. Eyes without active or regressed neovascularization at 2 years were not significantly different. One eye in the [Lucentis] group developed endophthalmitis [i.e., an inflammation of the eye, usually caused by infection]. No significant differences between groups in rates of major cardiovascular events were identified.

Conclusions and Relevance: Among eyes with proliferative diabetic retinopathy, treatment with [Lucentis] resulted in visual acuity that was non-inferior to (not worse than) [laser] treatment at 2 years. Although longer-term follow-up is needed, [Lucentis] may be a reasonable treatment alternative, at least through 2 years, for patients with proliferative diabetic retinopathy.

Related Diabetes Information


Topics:
Clinical Trials
Diabetes and diabetic retinopathy
In the News
Low Vision
Lucentis
Medical Updates

New Research: Emotional Support and Physician Communication Must Accompany Medical Treatment for Age-Related Macular Degeneration

American Journal of Ophthalmology logo

Although the advent of anti-VEGF therapy (explained below), administered via eye injection with Lucentis, Eylea, or Avastin, has revolutionized the treatment (but not cure) of wet age-related macular degeneration (AMD), there remain a number of challenges associated with treatment, including the need for appropriate emotional support and development of effective coping strategies.

A new study from the United Kingdom of 300 patients with wet AMD and 100 of their caregivers concurs with this pressing need for emotional support, revealing that "as many as 89% of patients who showed anxiety and 91% who showed depression were not receiving appropriate emotional and psychological treatment." The primary sources of anxiety that patients reported were "fear of going blind owing to … eye injections and concerns about treatment effectiveness, rather than pain [associated with injections]."

Says study co-author Dr. Tariq Aslam, "There have been amazing scientific achievements in diagnosing and treating serious eye diseases, such as wet AMD, which have revolutionized our ability to reverse life-changing vision loss. However, we must not forget the human element when applying all this to ensure all our patients can reap the full benefits of this cutting-edge science."

About the Research

This new study addressing the need for emotional support, titled Experience of Anti-VEGF Treatment and Clinical Levels of Depression and Anxiety in Patients with Wet Age-Related Macular Degeneration (explained below), has been published online ahead of print in the American Journal of Ophthalmology, a peer-reviewed, scientific journal published monthly since 1884. The Journal specializes in original research directed to ophthalmologists and visual science specialists that "describes clinical investigations, observations, and laboratory investigations."

The authors are Hugo Senra, Konstantinos Balaskas, Neda Mahmoodi, and Tariq Aslam, from the University of Manchester and Manchester Royal Eye Hospital, Manchester, United Kingdom; and Leeds Beckett University, Leeds, United Kingdom.

About the Macular Degeneration and Emotional Support Research

Excerpted from Effective communication from doctors could reduce anxiety for wet age-related macular degeneration patients, via ScienceDaily:

Wet macular degeneration (wAMD) is the commonest cause of vision loss in the western world, but modern treatments have dramatically improved the level of vision patients can expect to retain. These treatments involve regular injection of vascular endothelial growth factor inhibitors (anti-VEGF) into the eye.

However, a new study conducted at Manchester Royal Eye Hospital … demonstrates high levels of undiagnosed anxiety and depression persisting in patients receiving treatment, despite their improved visual outcomes.

The researchers say that the study findings demonstrate the value of human interaction between clinician and patient in offering reassurance around the efficacy and safety associated with anti-VEGF injections.

[Study co-author] Dr. Tariq Aslam said, "There have been amazing scientific achievements in diagnosing and treating serious eye diseases, such as wAMD, which have revolutionized our ability to reverse life-changing vision loss. However, we must not forget the human element when applying all this to ensure all our patients can reap the full benefits of this cutting-edge science.

The report suggests that patients may benefit from additional assurances from clinical staff regarding success rates in halting disease progression with anti-VEGF therapy; how it can reduce the risk of becoming blind in the future; and the low likelihood of serious problems occurring following the injections.

The research found as many as 89% of patients who showed anxiety, and 91% who showed depression were not receiving appropriate psychological and psychiatric treatment.

More about Wet Age-Related Macular Degeneration

NEI image of how someone with macular degeneration sees: overall blurriness with a blind spot in the center

Seeing the world with AMD

Age-related macular degeneration (AMD) is a gradual, progressive, painless deterioration of the macula, the small sensitive area in the center of the retina that provides clear central vision. Damage to the macula impairs the central (or "detail") vision that helps with essential everyday activities, such as reading and writing, preparing meals, watching television, and personal self-care.

AMD is the leading cause of vision loss for people aged 60 and older in the United States. According to the American Academy of Ophthalmology, 10-15 million individuals have AMD and about 10% of people who are affected have the "wet" type of AMD.

Wet (Neovascular) Macular Degeneration

In wet macular degeneration, the choroid (a part of the eye containing blood vessels that nourish the retina) begins to sprout abnormal blood vessels that develop into a cluster under the macula, called choroidal neovascularization (neo = new; vascular = blood vessels).

The macula is the part of the retina that provides the clearest central vision. Because these new blood vessels are abnormal, they tend to break, bleed, and leak fluid under the macula, causing it to lift up and pull away from its base. This damages the fragile photoreceptor cells, which sense and receive light, resulting in a rapid and severe loss of central vision.

Eylea, Lucentis, Avastin, and Anti-Angiogenic Drugs

retina with wet AMD

A retina with wet AMD

Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue.

Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and AMD (retinal and macular bleeding).

Substances that stop the growth of these excessive blood vessels are called anti-angiogenic (anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels).

The focus of current anti-angiogenic drug treatments for wet AMD is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs, including Lucentis, Avastin, and Eylea, are classified as anti-VEGF treatments. These drugs are administered by injection with a very small needle directly into the eye after the surface has been numbed.

More from the American Journal of Ophthalmology

Here is more information about the study, excerpted from the article abstract:

Purpose: To investigate detailed patient experiences specific to receiving vascular endothelial growth factor inhibitors (anti-VEGF) for wet age-related macular degeneration (wAMD), and to acquire a snapshot of the frequency of clinically significant levels of depression, anxiety, and posttraumatic stress among patients and levels of burden in patients' [caregivers].

Methods: Three hundred patients with wAMD receiving anti-VEGF treatment and 100 patient [caregivers] were recruited. Qualitative data on patients' experience of treatment were collected using a structured survey. Standardized validated questionnaires were used to quantify clinically significant levels of anxiety, depression, and post-traumatic stress, as well as cognitive function and [caregivers'] burden.

Results: Qualitative data showed that 56% of patients (n = 132) reported anxiety related to anti-VEGF treatment. The main sources of anxiety were fear of going blind owing to intravitreal injections and concerns about treatment effectiveness, rather than around pain. From validated questionnaires, 17% of patients (n = 52) showed clinical levels of anxiety and 12% (n = 36) showed clinical levels of depression. Depression levels, but not anxiety, were significantly higher in patients who received up to 3 injections compared with patients who received from 4 to 12 injections and compared with patients who received more than 12 injections.

Conclusion: Anti-VEGF treatment is often experienced with some anxiety related to treatment, regardless of the number of injections received. Clinical levels of depression seem to be more frequent in patients at early stages of anti-VEGF treatment. Strategies to improve patient experience of treatment and minimize morbidity are suggested.

Resources for Emotional Support and Macular Degeneration


Topics:
Aging
Avastin
Caregiving
Eylea
In the News
Low Vision
Lucentis
Macular Degeneration
Medical Updates
Support Groups

During Vision Rehabilitation Therapy Awareness Week: Considering the Increasing Role of Technology

By Steve Kelley, CVRT, CRC

Celebrating Vision Rehabilitation Therapy Awareness Week

Helen Keller and Anne Sullivan playing chessHelen Keller and Anne Sullivan playing chess

The week of April 9-15, 2017 is Vision Rehabilitation Therapist Awareness Week. The week commemorates the birthday of Anne Sullivan, who was Helen Keller's teacher (both pictured at left).

With this celebration comes the question of "How has the role of a Vision Rehabilitation Therapist (VRT) changed with the advent of more technology?"

The agency I work for, in Portland, Maine, like many others across the country, has been asking this same question. A critical issue is trying to ascertain what level of competence VRTs should be expected to have, and with which technology.

Vision Rehabilitation Therapists: A Question of Competency

Haven't VRTs always been expected to maintain a certain level of competency, in a wide variety of adapted daily living skills, including the latest technology? As the profession of "Home Teachers" (the earliest description of blindness professionals or vision rehabilitation therapists) developed through the mid to late 1800s, these teachers, often visually impaired themselves, were training students to use a wide variety of technologies.

For the time, "finger reading," adapted crafting techniques, signing, and using a cane for travel were certainly new techniques for independent living, often involving some new technology. In fact, Lynda Jones, CVRT, in her article From Home Teacher to Vision Rehabilitation Therapist: A Legacy, recounts the persistent legend of a Home Teacher packing the hatchet one might need to prepare a free-range chicken for the stew pot! How's that for cutting edge technology?

The Vision Rehabilitation Therapist Model

learning to cook with a VRT

Learning to cook with the help of a Vision Rehabilitation Therapist

Consider for a moment the following excerpt from the primary textbook for the field of Vision Rehabilitation Therapy (called "Rehabilitation Teaching" at the original time of publication), Foundations of Rehabilitation Teaching With Persons Who Are Blind or Visually Impaired, by Susan V. Ponchillia and Paul E. Ponchillia:

A rehabilitation teacher is a professional whose primary goal is the rehabilitation of individuals who are visually impaired — that is, the provision of instruction and guidance to help individuals to acquire the skills and knowledge to manage their daily lives (Asenjo, 1975b) and to achieve self-confidence and self-sufficiency at their highest attainable level (LaGrow, 1992).

Regardless of the changing skills used to manage a client's daily life — prepping a hen for supper, or placing an online supper order at a local restaurant for an Uber pickup and delivery — these are the sorts of skills and accompanying technologies the VRT teaches.

What's Changed? A Veteran VRT Remembers

To get a better understanding of how the scope of teaching technology skills has changed more recently, I spoke with a co-worker and mentor, Laura Vittorioso, CVRT, CLVT, who began working in the profession in 1977, in Southern Maine.

Laura's Viewpoint

Laura reported that during that time, her work was focused on connecting people with services, teaching various craft activities, braille alphabet training, optical magnification, and Talking Books, which were then recorded on flexible vinyl records.

reading with a CCTV

Reading with a modern CCTV

"We knew there were devices out there," she said, "like the Aladdin CCTV (closed circuit television, now called an electronic video magnifier, pictured at left), and the Optacon (or OPtical to TActile CONverter) that people were using, but we didn't have anything like that — we had so little to work with."

By the late 1980s, Vittorioso reported that there was a greater influx of State funding into the agency, and with it, training on the technology that was being used at the time, such as the new video magnifiers.

Technology Was Lower-Tech

"In those days," she said, "there was technology, but it was more a lower-tech device that we were learning to use. Those of us who have been around for awhile are particularly more challenged by how quickly technology has advanced. Not growing up with it as many of the younger people have, it's not as intuitive for us."

A Shift in Training Focus

Vittorioso also reported a dramatic shift in training focus. During the past 10 years, clients' goals have shifted from what was primarily training in independent household management skills, such as cooking, cleaning, and bill-paying, to more of a technology focus.

"It has changed dramatically," she said. "Rarely am I teaching the traditional homemaking skills now. Most often, we're teaching technology: "How do I use my iPad?" "How do I use my iPhone?" "I want to get on a computer!" "I want an ebook!" And of course, clients want to learn the low vision tools."

A Training Supervisor Concurs: Boomers Love Tech!

Vittorioso's observations were similar to those made by B.J. LeJeune, CVRT, CRC, Training Supervisor at the National Research and Training Center on Blindness and Low Vision, at the recent American Foundation for the Blind Leadership Conference. B.J remarked that as Boomers acquire vision loss from aging, they will be seeking services and training to support the continued use of the gadgets they have come to enjoy.

The Boomers' love affair with gadgets reflects the degree to which technology has become a vital part of our daily living activities, and how prevalent accessibility is becoming as an integrated part of mainstream technology.

An Example of Tech Transformation

the National Library Service Digital Talking Book Player

The NLS Digital Talking
Book Player and cartridge

Consider for a moment the transformation that took place in the past several years with the National Library Service Talking Book Player and services. It has gone from a cassette player to a completely digital media player, capable of playing a variety of file formats, using a flash drive as well as the more standard cartridges, and allowing more advanced users to download books and magazines to their computers and transfer them to a cartridge or flash drive.

Patrons may do away with the player altogether by installing the BARD Mobile app on a smart device. Teaching consumers how to use what was once a relatively low tech device has suddenly become much more high tech — including computer and tablet skills at the more advanced level. Not only that, but BARD Mobile can be downloaded and operated on a $49 Kindle Fire HD available from Amazon with a screen reader already built in!

Suddenly, the old reliable, simple Talking Book player includes a computer, a tablet, flash drives, and digital cartridges — enough to make a technophobe very anxious indeed!

The Tech May Be More Familiar Than You Think!

In many ways, although there is a great deal more mainstream technology coming out at a dizzying pace, some aspects of the technology learning acquisition will remain similar to what professional VRTs have experienced over the years: learning the basics of the technologies in vogue, and relying on some specialists for less popular or higher-tech items.

For example, the Talking Book Player remains a standard, and training is readily available. Tablets and smartphones as a category of devices are now a standard, and training for the basic screen magnification and screen reader gestures has become more standardized with training resources available.

The Orbit Reader 20 braille book reader will, no doubt, also become a standard device with many training opportunities. Of course these devices may include a bit of a learning curve between upgrades and models, but once you learn the basics, the changes are minor.

Referring to a Technology Specialist

On the other hand, there will most likely be increasing demand for more specialized trainers —VRTs who are familiar with several screen readers and operating systems, more specialized braille note takers, advanced skills, such as editing documents using VoiceOver with a keyboard, and scripting for customization.

A New Technology Certification

The vision rehabilitation field's certifying body, the Academy for Certification of Vision Rehabilitation & Education Professionals, recognized this with their latest certification: Certified Assistive Technology Instructional Specialist for People with Visual Impairments (CATIS).

This new certification seems to be a recognition that there will continue to be a need for a higher level of training for some specialists, and that the standard knowledge base for VRT certification may include more technology, although not at the level of a certified specialist.

Vision Rehabilitation Therapists Remain Versatile

As in so many other professions, the technology we are using changed, and the speed at which it is changing is even faster today. We are all using smartphones and tablets instead of DayTimers and paper calendars. We tap on tablets of all shapes and sizes rather than scribble on paper or braille with a stylus.

We ask Siri to take a memo or remind us to take our medication. In a few years, we may be adding bump dots or braille labels to flat panel consoles in self-driving cars for owners and travelers who are visually impaired.

It is just this sort of versatility that Vision Rehabilitation Therapists have demonstrated historically as a profession, as teachers, and as trainers that will enable them to manage and embrace new technology as it develops!

Additional Information about Vision Rehabilitation Therapists


Topics:
Assistive Technology
Books
Helpful Products
Low Vision
Online Tools
Personal Reflections
Planning for the Future
Reading
Technology
Web Accessibility

H.R.2050: The Medicare Demonstration of Coverage of Low Vision Devices Act of 2017 Needs Your Advocacy and Support

the dome of the US Capitol building

Dome of the U.S. Capitol

The American Foundation for the Blind (AFB) Public Policy Center has announced the reintroduction of federal legislation that seeks to establish a nationwide Medicare demonstration project to evaluate the fiscal impact of a permanent change in Medicare coverage that would, for the first time, provide reimbursement for low vision devices.

The AFB Public Policy Center, in Washington, DC, collaborates with policy makers in Congress and the Executive Branch to ensure that Americans with vision loss have equal rights and opportunities to fully participate in society.

The Legislation: H.R.2050

The legislation, now titled H.R.2050 – The Medicare Demonstration of Coverage of Low Vision Devices Act of 2017, has been reintroduced by Representative Carolyn Maloney (D-NY) and co-sponsored by Representatives Gus Bilirakis (R-FL) and Steve Cohen (D-TN). The bill directs the Secretary of Health and Human Services "to provide for a Medicare demonstration project to evaluate the fiscal impact of covering low vision devices as durable medical equipment under Part B of the Medicare program."

In other words, just as a person might need a cane or a walker after a physical injury, so would a person with low vision need a low vision device to continue to function as independently as possible.

The proposed legislation defines low vision devices as "a device, prescribed by a physician that magnifies, enhances, or otherwise augments or interprets visual images irrespective of the size, form, or technological features of such device and does not include ordinary eyeglasses or contact lenses. The term 'ordinary eyeglasses or contact lenses' means lenses that are intended to fully correct visual acuity or fully eliminate refractive error."

The legislation requires that the five-year demonstration project be genuinely national in scope and is explicitly designed to yield reliable data and meaningful results.

Some Background on Medicare and Low Vision Devices

For decades, the vision loss community has been advocating for Medicare's coverage of assistive technologies, particularly low vision devices. Currently, Medicare will not pay for any device that happens to use a lens, regardless of whether the device incorporates any other features.

The Centers for Medicare and Medicaid Services (CMS), the federal agency responsible for the management of Medicare, has ruled that devices containing a lens – such as low vision optical devices and electronic magnifiers – are excluded from coverage, just as are eyeglasses or contact lenses, except in very narrow circumstances, such as intraocular lenses for cataract surgery.

More about Low Vision Devices

Low vision devices, such as optical devices and electronic and digital magnifiers, can help you make the most of your vision so that you can perform everyday tasks more easily and with less frustration. All low vision devices require training in order to use them efficiently and effectively.

Low Vision Optical Devices

a hand-held lighted magnifier

A hand-held lighted magnifier

Low vision optical devices include a variety of helpful visual aids, including stand and hand-held magnifiers, strong magnifying reading glasses, loupes, and small telescopes.

Because these devices can provide greatly increased magnification powers and prescription strengths, along with higher-quality optics (i.e., the way the lens bends or refracts light), they are different from regular glasses and magnifiers that you can buy in a local store or online.

Electronic Magnifying Systems

Electronic magnifying systems come in many different varieties and sizes, depending upon the task or activity you want, or need, to do. Some have a camera system that displays a magnified image on a monitor, which can be helpful for reading mail, books, and magazines, while others are hand-held, portable, and can be taken to the supermarket to read labels and coupons, or to restaurants for reading menus.

reading a magazine with a digital magnifier

Reading a magazine with
a portable digital magnifier

Both types of low vision devices are often recommended as part of a low vision examination. A low vision exam by a low vision specialist — an ophthalmologist or optometrist with credentials or specialization in low vision testing, diagnosis, and treatment — is the best way to decide what type of device or devices are best for you, your eye condition, and your everyday living needs. At your low vision evaluation, you will have the opportunity to try a variety of devices in a variety of settings and learn first-hand how they can work for you.

More from Sponsor Carolyn Maloney (D-NY)

In her introductory remarks for the prior (2015-2016) version of this reintroduced bill, sponsor Carolyn Maloney said the following:

Mr. Speaker, it is estimated that more than 60 million Americans are at risk of serious vision loss – a number expected to increase as the baby boomer generation ages. Along with [my colleagues], I am proud to reintroduce legislation to support Americans with limited or impaired vision. For someone with a visual impairment, reading a book or crossing the street could be blurred or distorted, even with the help of glasses or contact lenses.

In many cases, a physician can prescribe magnifiers or special optical devices to help an individual remain independent. While there are a wide variety of options to help people with low vision, currently there is an exclusion from Medicare coverage for devices that include a lens to aid vision or provide magnification of images for impaired vision. Ultimately, not having these assistance devices could shift more individuals from independent living to care facilities or nursing homes.

What Can You Do?

Talk to your Representatives about co-signing the bill and help identify a Senator who might be interested in filing a companion bill in the Senate. Use the Find Your Representative link to identify your congressional district and link to your member's website and contact page. Use the United States Senate link to find your Senators.

Here is some suggested language to use when you make a call or send an email:

  • Tell your Representative, "I support H.R.2050 because assistive devices help to guarantee the independence of people with vision loss. Please co-sponsor this bill."
  • Tell your Senator, "I support Medicare coverage of low vision devices to help guarantee the independence of people with vision loss. Please introduce a Senate companion to H.R.2050."

The bill is currently one of the 2017 legislative imperatives of the American Council of the Blind (ACB). "As more and more older Americans encounter significant vision loss, it's critical that government seek out pathways that can sustain independence in the home," says Kim Charlson, president of ACB. "The more we can sustain independence for daily living, the less reliant individuals with significant vision loss will be on more costly alternatives like assistive living."

For more information about this important reintroduced legislation, contact the AFB Public Policy Center: Director Mark Richert, Esq. at MRichert@afb.net or Senior Policy Researcher Rebecca Sheffield, Ph.D. at RSheffield@afb.net.

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Do the Brains of Blind Persons "Rewire" or Adjust to Significantly Enhance the Other Senses? New Research Says Yes

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An age-old question that surfaces regularly in my work is this one: "Is it true that blind people develop super senses, like extra-sensitive hearing or touch, to compensate for not being able to see?"

A variation of the "super senses" question asks this: "Are the other senses truly enhanced, or do people without the sense of sight – and the input it provides – learn to pay closer attention to information received through the other senses?"

Indeed, researchers, scholars, and philosophers have addressed this elusive question for many years:

Most recently, neuroscience researchers from Harvard Medical School and Boston University have revealed that the brains of people who are born blind or became blind in early childhood are wired differently from the brains of people who were born with sight. Their study describes, for the first time, the combined structural, functional, and anatomical changes in the brain that are evident in people born with blindness that are not present in the brains of sighted persons. As a result of their research, they conclude that the brain is able to "rewire" itself when visual information is not available.

The Brain "Rewiring" Study

This new blindness and the brain study, titled Multimodal magnetic resonance-imaging [MRI] reveals large-scale structural and functional connectivity changes in profound early blindness, has been published online in the March 22, 2017 edition of PLoS ONE, an international, peer-reviewed, open-access online journal, published monthly by the Public Library of Science (PLoS). The PLoS is a non-profit organization of scientists and physicians who are committed to making the world's scientific and medical literature a freely available public resource.

The authors are Corinna M. Bauer; Gabriella V. Hirsch; Lauren Zajac; Bang-Bon Koo; Olivier Collignon; and Lotfi B. Merabet, from the Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA; Boston University School of Medicine; and the University of Trento, Italy.

About the Brain Plasticity Research

Excerpted from Brain 'rewires' itself to enhance other senses in blind people, via EurekAlert!, the Global Source for Science News:

The researchers used MRI multimodal brain imaging techniques to reveal these changes in a group of 12 subjects with early blindness (those born with or who have acquired profound blindness prior to the age of three), and they compared the scans to a group of 16 normally sighted subjects (all subjects were of the same age range).

[Editor's note: Magnetic resonance imaging (MRI) uses a strong magnetic field and radio waves to create detailed images of the organs and tissues within the body, including the brain.]

On the scans of those with early blindness, the team observed structural and functional connectivity changes, including evidence of enhanced connections, sending information back and forth between areas of the brain that they did not observe in the normally sighted group.

These connections that appear to be unique in those with profound blindness suggest that the brain "rewires" itself in the absence of visual information to boost other senses. This is possible through the process of neuroplasticity, or the ability of our brains to naturally adapt to our experiences.

The researchers hope that increased understanding of these connections will lead to more effective rehabilitation efforts that will enable blind individuals to better compensate for the absence of visual information.

"Our results demonstrate that the structural and functional neuroplastic brain changes occurring as a result of early ocular blindness may be more widespread than initially thought," said lead author Corinna M. Bauer, Ph.D. "We observed significant changes not only in the occipital cortex (where vision is processed), but also areas implicated in memory, language processing, and sensory motor functions."

"Even in the case of being profoundly blind, the brain rewires itself in a manner to use the information at its disposal so that it can interact with the environment in a more effective manner," said senior author Lotfi Merabet, O.D., Ph.D. "If the brain can rewire itself - perhaps through training and enhancing the use of other modalities like hearing, and touch and language tasks such as braille reading - there is tremendous potential for the brain to adapt."

More about the Study from PLoS

Excerpted from Multimodal MR-imaging reveals large-scale structural and functional connectivity changes in profound early blindness, with full text, graphs, and figures available online as an open-source article:

Introduction

Ocular blindness has served as an important model in helping to understand the consequences of sensory deprivation on brain development. Extensive work in animal models has provided compelling anatomical and behavioral evidence regarding the dramatic neuroplastic changes that result from altering visual experience.

In humans, there has been considerable interest in relating neuroplastic changes with compensatory behaviors observed in individuals living with profound blindness. Indeed, there is mounting support that blind individuals (particularly, when blind from birth or very early in life) demonstrate comparable, and in some cases even superior, behavioral skills as compared to their sighted counterparts.

[Editor's note: Neuroplasticity refers to the ability of our brains to adapt naturally to our experiences and specific life needs.]

Taken together, a contemporary view suggests that these compensatory behaviors may be intimately related to underlying changes in the overall structural and functional organization of the brain. This reorganization implicates areas responsible for the processing of intact senses such as touch, hearing, and smell. At the same time, there is also evidence of cross-modal reorganization within occipital cortex; that is to say, the area of the brain normally ascribed to processing visual information.

Specifically, numerous neuroimaging studies have demonstrated that blind individuals show robust activation within occipital cortical areas while performing a variety of nonvisual tasks (e.g. braille reading, sound localization, and odor perception), as well as higher order cognitive tasks including language processing and verbal memory recall.

The Study Participants

A total of 28 subjects were recruited for the study and separated into two groups comprised of 12 early blind (6 females, mean age 33.58 years) and 16 normally sighted controls (8 females, mean age 30.44 years). Comparing demographic factors between both groups revealed no statistically significant differences in terms of age or gender. For the purposes of this study, we defined "early blind" as documented residual vision no greater than light perception and/or hand motion acquired prior to the age of three (i.e. prior to the recall of visual memories and the development of high level language function).

While the majority of participants had diagnoses that could be considered as a "congenital" cause, we relied on documented clinical evidence of profound blindness based on a structured and functional assessment. The etiologies of blindness were varied and included retinal dystrophies as well as ocular malformations. However, no single diagnosis was represented in more than three subjects.

All blind participants were highly independent travelers, employed, college educated, and experienced braille readers. They were predominately right handed (based on self-report), but most used two hands for the purposes of reading braille text. Sighted controls had normal, or corrected-to-normal, visual acuity. Apart from blindness, the participants had no documented history of neurological abnormalities.

Interpretation of the Study Findings

As mentioned earlier, there has been considerable interest in relating compensatory behaviors in blind individuals within the context of observed structural and functional neuroplastic changes in the brain. While compensatory abilities in the blind have been reported across a wide variety of behavioral tasks and implicating different sensory modalities, it is important to note that these abilities are not universally evident across the blind population. Indeed, while there is evidence of enhanced sensory and cognitive task performance, there are also other reports suggesting that the blind are equal or even impaired on certain tasks compared to the their sighted counterparts.

This suggests that the absence of visual experience can induce either sensory compensation or the absence of calibration depending of the task-cognitive domain at play. Specifically, comparable (or even superior) perceptual and cognitive processing abilities in the blind (through the use of intact sensory modalities) would be in line with a "compensatory" hypothesis of neuroplasticity.

Recent work has also highlighted important differences in functional connectivity derived from resting state sequences with that of functional connectivity that characterizes task-specific activity. More specifically, it has been suggested in a number of reports that differences in connectivity patterns between populations are task dependent and that task related and resting state functional connectivity in fact do not coincide.

This provides further caution against inferring differences in functional integration between brain regions solely based on resting-state data. In this direction, it has been shown that whole-brain functional connectivity networks can fundamentally change in different task contexts and thus are not constrained by networks identified solely by resting-state analyses.

… To help resolve these inconsistencies, further studies should compare metrics of brain structure, white matter structural connectivity, along with measures of effective connectivity as well as individual parametric measures of behavioral performance. Again, by leveraging the advantages of multi-modal imaging, we are more likely to better understand how structure, connectivity, and behavior are reciprocally linked.

What Does the Future Hold?

According to a review of the research at Gizmodo, the researchers did not perform any behavioral or sensory tests that would determine if their subjects truly had heightened senses of touch, hearing, smell, but admit it's an area ripe for future examination:

Looking ahead, [the research team] would like to use this study as a model for studying brain changes in a different population of individuals with visual impairments, specifically those with visual dysfunctions not because of damage to the [eye], but because of early developmental brain damage to areas of the brain responsible for visual processing. This condition, known as cortical or cerebral visual impairment (CVI), is the leading cause of pediatric visual dysfunction in developed countries around the world.

VisionAware will continue to report on the progress of this research as results become available.

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