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New CDC Research Investigates the Association between Vision Loss and Quality of Life

the CDC logo

A major new study from the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC) has investigated the association between visual impairment and health-related quality of life among adults aged 65 and older.

The research concludes that poor health-related quality of life is strongly associated with the severity of self-reported visual impairment among people aged 65 and older who participated in the study. Participants who reported "moderate/severe" visual impairment showed a strong, consistent association with poor health-related quality of life.

From Ophthalmic Epidemiology

Head shot of Dr. John E. Crews

The research, entitled Health-Related Quality of Life Among People Aged ≥65 Years with Self-reported Visual Impairment: Findings from the 2006–2010 Behavioral Risk Factor Surveillance System, has been published in the October 2014 edition of Ophthalmic Epidemiology, which encompasses the epidemiological, clinical, educational, environmental, and cultural aspects of eye disease, prevention of blindness, preservation of sight, and visual rehabilitation.

[Editor's note: Epidemiology is a branch of medical science that studies the incidence, distribution, and control of disease in a population. It forms the cornerstone of public health and informs policy decisions and evidence-based health practice.]

The authors are John E. Crews; Chiu-Fang Chou; Xinzhi Zhang; Matthew M. Zack; and Jinan B. Saaddine, from the National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia.

Lead author John E. Crews, DPA (pictured above left), is a Health Scientist with the Vision Health Initiative of the CDC's National Center for Chronic Disease Prevention and Health Promotion. Dr. Crews's specialties are vision impairment and aging, caregiving, and disability. His research interests also include health disparities among people with disabilities, and aging with a disability.

Some Background: The CDC Behavioral Risk Factor Surveillance System

The CDC's Behavioral Risk Factor Surveillance System (BRFSS) is the world's largest ongoing telephone health survey system, tracking health conditions and risk behaviors in the United States yearly since 1984. Currently, data are collected monthly in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and Guam.

The BRFSS Vision Module was developed by CDC's Vision Health Initiative. Nineteen states have begun using it since its implementation in 2005. The Vision Module surveys adults aged 40+ and contains nine questions about visual function, eye diseases, frequency of eye examinations, and reasons for not seeking eye care.

First, the Research Summary

From the article abstract:

Purpose: To examine the association between health-related quality of life and visual impairment among people aged ≥65 years [i.e., greater than or equal to 65 years old].

Methods: We used cross-sectional data from the 2006–2010 Behavioral Risk Factor Surveillance System to examine six health-related quality of life measures: (a) self-reported health, (b) physically unhealthy days, (c) mentally unhealthy days, (d) activity limitation days, (e) life satisfaction, and (f) disability. Visual impairment was categorized as (a) no, (b) a little, and (c) moderate/severe.

[Editor's note: A cross-sectional study involves an analysis of a population of subjects at one specific point in time, rather than studied over a longer, or more extended, period of time.]

Results: People with self-reported moderate/severe visual impairment had more frequent (≥14) [i.e., greater than or equal to 14] physically unhealthy days, mentally unhealthy days, and activity limitation days in the last 30 days compared to those reporting "a little" or "no" visual impairment.

After controlling for all [variables] (age, sex, marital status, race/ethnicity, education, income, diabetes, heart disease, stroke, heart attack, body mass index, leisure time activity, smoking, and medical care cost concerns) and comparing to those with no self-reported visual impairment, people reporting "a little" visual impairment were more likely to have fair/poor health; life dissatisfaction; and disability.

Those with self-reported "moderate/severe" visual impairment had more fair/poor health; life dissatisfaction; and disability. They also had more frequent physically unhealthy days; mentally unhealthy days; and activity limitations days.

Conclusion: Poor health-related quality of life is strongly associated with the severity of self-reported visual impairment among people aged ≥65 years [i.e., greater than or equal to 65 years old].

Highlights from the Research

Characteristics of the Study Subjects

  • Among the study population, 54% were aged 65–74 years, 58% were women, 7.4% were non-Hispanic black, and 6.0% were Hispanic.
  • Compared to those reporting no visual impairment, more women, non-Hispanic blacks, Hispanics, those with less education, and those with annual household incomes below $35,000 reported moderate/severe visual impairment.
  • Increased severity of self-reported visual impairment was consistently associated with four chronic conditions: diabetes, heart disease, stroke, and heart attack.
  • Increased severity of self-reported visual impairment was also associated with worse health-related quality of life.

Difficulties in Defining and Measuring "Quality of Life"

  • Quality of life research has moved from measures of necessities for food and shelter to measures of "fulfillment and personal happiness," reflecting social priorities and changing outcomes in medicine.
  • The World Health Organization quality of life instrument, for example, defines quality of life as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns."
  • The CDC's health-related quality of life questions, on the other hand, address "an individual's or group's perceived physical and mental health over time." Therefore, the CDC quality of life measures range from general well-being, to task performance, to overall physical and mental health.
  • Each concept measures important – but different – quality of life characteristics.

The Presence of Multiple Health Problems among People with Visual Impairment

  • The study findings also reveal the significance of multiple chronic health conditions among people with visual impairment. The study participants who reported having heart disease, heart attack, diabetes, and stroke also reported poorer health-related quality of life.
  • After controlling for these health conditions in the research, however, visual impairment was still associated with poorer health-related quality of life.
  • Thus, it is extremely important to recognize and address the effects of visual impairment on many aspects of health and quality of life.

Looking at Vision Loss from a Public Health Point of View: Study Recommendations

As the authors note in the study conclusions,

From a public health point of view, addressing the six CDC health-related quality of life measures may identify potential pathways to improve overall health-related quality of life, especially among those reporting the most severe visual impairment.

For example, ample evidence exists demonstrating that improved access to eye care results in positive health outcomes. Refractive error [i.e., needing eyeglasses] remains a substantial problem for older people, but Medicare does not pay for [eyeglasses], and those reporting more severe visual impairment indicate greater concerns for health care costs.

While removing impediments to access to eye care and health care lead to positive health outcomes, further research could identify whether additional gains in health-related quality of life may occur by addressing health promotion and health behaviors targeting those with visual impairment.

Our findings show that people with moderate/severe self-reported visual impairment had higher prevalence of chronic conditions, obesity, current smoking, and lack of leisure-time physical activity. Altering health promotion interventions and promoting health behaviors to include people with vision problems might lead to better health-related quality of life outcomes. Health promotion materials in large print or electronic formats might improve participation.

Similarly, efforts to improve health behaviors, like being physically active, might include improved availability of sidewalks and better illumination to promote walking.

These avenues have not been rigorously investigated and require additional attention, but … tailored interventions might lead to improved self-reported health, fewer physically unhealthy days, fewer mentally unhealthy days, and improved life satisfaction.

Additional Information


Topics:
Low Vision
Health
Public Policy

What's New in iOS 8 Accessibility Part 2: Scott Davert, AppleVis Editorial Team

Scott Davert head shot

Guest blogger Scott Davert, M.A., VRT, is an AppleVis Editorial Team Member and a regional representative for the Region 8 Rocky Mountain area with the Helen Keller National Center for Deaf-Blind Youths and Adults.

Most recently, Scott compiled his personal picks for book-reading apps and iDevice apps that are user-friendly and accessible to braille, and also speech, users.

According to Scott, "As a power user of braille devices on iOS, it's very liberating to me, as a deaf-blind person, to be able to take full advantage of the technology we have in our society today. Just a decade ago, my access to resources was much more limited if braille was my only means of accessing the world. Today, with the help of technology, I can be just as well-informed about what's going on around me as my sighted and hearing counterparts."

This month, Scott is reviewing the new iOS 8 release from Apple, with an emphasis on accessibility features for individuals who are blind, deaf-blind, or have low vision. iOS is Apple's mobile operating system, or OS. Originally developed for the iPhone, it has since been extended to support other Apple devices, such as the iPod touch and iPad. In June 2010, Apple rebranded the iPhone OS as simply iOS.

In Part 1 of his review, Scott discussed Siri updates, including hands-free operation and Audio Ducking, and VoiceOver changes, including Direct Touch Typing and the new built-in braille keyboard. In Part 2, Scott discusses additional changes for braille users and updates for users who have low vision.

Braille Changes in iOS 8

Uh, Hello? Is This Thing On? Are There Any Cells Left in This Brain?

This bug, for braille users, is being reported here because it is very critical. If you go to Settings > General > Accessibility > VoiceOver > Braille > Status Cells, do not change the Off setting to either the Right or Left setting. Doing so will render VoiceOver and braille inoperable until a sighted person can turn the Status Cells to the Off setting again.

Braille Input via Braille Display

The letter z represented in braille

braille input using a braille display has become more sluggish in iOS 8, regardless of which input mode you are using. For example, typing a sentence such as, "Hello, my name is Scott," will still produce the correct result – but the process will take about five seconds longer.

With iOS 8, each letter you press is automatically displayed next to a full 8-dot cell at the beginning of the display and again at the end. It is then fed through the translator and finally comes out on the iDevice. It's important to keep track of when all of the text has been entered, so that when you move to a button, or wish to move to another field on a web page, for example, all of the text has been entered accordingly.

Quickly Use QuickNav

One feature that Bluetooth keyboard users of VoiceOver have enjoyed since the release of iOS 5 is QuickNav in Safari. It's now possible to carry out these commands using a braille display's input keys as well. Pressing "space + Q" should toggle QuickNav on and off, though VoiceOver always reports it as being on.

The same keyboard commands that Bluetooth keyboard users know, such as pressing H for the next heading, C for the next checkbox, and F for the next text field, all apply here as well. As someone who is primarily a braille-only user, this is a welcome addition to iOS braille support. However, even loading the same page on the same configuration will not always yield reliable results. Further, restarting VoiceOver will not always fix the issue.

That Was a Real Page Turner? I Didn't Know!

For quite some time, speech users of VoiceOver have enjoyed the ability to not have to worry about turning pages in various book reading applications. However, if you're using a braille display to read content, you always had to turn pages by actually pressing the command to do so.

In iOS 8, if you go in to the VoiceOver settings for braille, you will find an option called "Turn Pages When Panning" and you will no longer need to worry about doing this. Note that this feature seems to work best in the Kindle app, as using it in iBooks presents you with a page number each time the page is turned--and you have to wait a couple of seconds before you can resume reading.

My Input Doesn't Match My Output. Is That Okay?

One of the more frustrating things with using a braille display on the iOS platform is when you try to use contracted braille and are a slower braille typist. Those who write braille slowly or who don't wish to use the translator found in the braille driver had to toggle between contracted and uncontracted braille each time they wanted to write. Now, this is no longer necessary.

You can cycle through changing the input (what you're typing) mode by pressing "space + G" to go between contracted, uncontracted, and 8-dot computer braille. You can also set your output (what you're reading) independently of the input mode – cycle through the same three options by using "space + dots 2-3-6." These options are also configurable in VoiceOver's braille settings.

Low Vision Changes in iOS 8

Most of the information in this particular section of the article was garnered through talking with low vision users. As I have never had sight, it is impossible for me to evaluate this access method personally. In particular, I would like to thank Amy Mason for giving this a thorough look-through and providing much of the following information pertaining to low vision.

Boldly Moving Forward…Sort Of

In Settings under General > Display and Brightness, you will now find the Bold Text option that used to be under the Vision heading in iOS 7. This feature is identical to bold text in iOS 7, except that it adapts to the color of the fonts on the Home Screen. If the Home Screen is light, the feature makes text dark; otherwise, text will be light. When the background color is somewhere in between, this setting will default to white text.

A New Zoom for a New Version of iOS

Prior to iOS 8, Zoom simply magnified the entire screen. However, the new Zoom now lives up to its name much more. When a user first enters "Zoom" in the "Accessibility" menu, he or she will find that Zoom can be toggled on and off and the instructions and method for using it are unchanged.

However, there are also a number of new features within the Zoom instructions:

  • Follow Focus: This setting determines whether or not the Zoom lens will follow the text cursor.
  • Show Controller: This toggle places a joystick on the screen, which can be used to move Zoom focus around, to bring up the new Zoom control panel, and to zoom in and out of an area quickly. (I found it easier to use than dragging three fingers to move my focus all over.)
  • Zoom Region: This feature allows a user to use Window Zoom (a smaller than full-screen lens) or Fullscreen (as in previous versions of iOS).
  • Maximum Zoom Level: This slider allows users to limit how much magnification Zoom will offer, which is helpful on iPod and iPhone due to screen size limitations.

Using Windowed Zoom

When a lens is enabled, the user will see a small horizontal bar at the bottom of the lens which allows for access to several controls and allows the user to move the lens itself. If you drag this control, you will move the lens; if it is single-tapped, Zoom will open an on-the-fly Zoom control panel.

From the control panel, a user can take advantage of several options. First, the user can zoom in or out and then choose between Fullscreen or Window Zoom. (Note: To regain access to the control panel without visiting Settings again, when Zoomed out or in Fullscreen, the controller must be on.) The Zoom lens can also be resized from this menu.

Users can also choose to filter just the zoomed lens. The options are Inverted, Greyscale, Inverted Greyscale, and Low Light, which dims the lens on screen only. You can also hide or show the controller from this menu and grow or shrink the magnification size.

VoiceOver and Zoom…Not Such a Happy Merger

The Zoom controller takes a back seat to VoiceOver if both are enabled, and using the more advanced Zoom features with VoiceOver seems as if it may involve a lot of frustration and compromise.

For instance, while testing with both Zoom and VoiceOver enabled, it did not seem possible to move the Zoom lens created earlier, and movement was restricted to the old Zoom controls. Most likely, the combining of both VoiceOver and Zoom with the new features is a work in progress.

All things considered, the improvement to Zoom is significant, but the tiny size of the iPhone and iPod screens will always limit its usefulness for more than spot checking. As this build of iOS 8 was only tested on an iPod, it’s unclear if these new features will be handier on an iPad.

Getting Cut Off While Sizing Up the Text

In iOS 8, text size can be increased in two different areas in Settings. First, the user can increase text size from the Display and Brightness menu; this will display a range of text size options. Never fear, though, as at the top end of the window, you are given the feedback that "Larger sizes are available in Accessibility Settings."

Once the user turns on "Larger Accessibility Size" under the Accessibility Settings, it will not increase the size of text in the Settings menus any further. However, a modest growth in the Settings menu itself will occur, which may be helpful. Also, the Lock Screen date text will increase to a small degree. Note that the text of some Settings panels are cut off when they are a larger size than the screen allows.

A moderate increase in text size can be seen in dialog boxes, Settings, Notifications, Tips, Voice Memos, the music player, and on the Lock Screen. Full-sized dynamic text can be seen in Notes, Mail, Reminders, and Messages. Generally, this can only be used when the user is inputting his or her own text, and not on most labels. However, some labels in contacts were enlarged.

Labels do cut off in the larger-sized text and do not appear to offer a method for reading the entire line they are on. Messages and notes will correctly wrap the words that are too long. Also note that no changes in text size were encountered in the App Store, Safari, or iTunes.

50 Shades of Grey on My iDevice?

By the time you factor in all of the options available with Zoom and now Grey Scale, which is a new feature, there are probably way more than 50 different shades of grey on your iDevice. Grey Scale, very literally, turns all of the content on your iDevice grey. This can be combined with Invert Colors or Zoom to assist the low vision user in any number of ways.

Speak It To Me

Another new setting called Speak Screen has been added in iOS 8 under Settings > General > Accessibility > Speech > Speak Screen. This option offers a simple way for low vision users to "read" the screen only.

This feature will give users access to rewind, fast forward, play/pause, and speed only. It is not intended to be a replacement for VoiceOver; rather, it is meant to be a simple solution for the times when a low vision user wants to read an entire screen quickly. When enabled, a Highlight Text toggle appears, showing a visual highlight of the paragraph being read.

Other Low Vision Changes

There are additional changes that you will find within the Settings > Accessibility option that are not listed under the vision heading:

Can You Describe That, Please?

Under Settings > General > Accessibility, you will now find a Media heading. Captioning, which was available in iOS 7 under the Hearing heading, has now been moved here. There is also a new option for video description. While I have not come across any content which has this feature yet, one would hope that in the near future, iTunes will start selling content that has video descriptions.

Take a Consistent Route

It's now possible to set where your incoming phone calls go to by default. For example, if you always want your calls to go to speakerphone instead of to the earpiece, you can now set this option. You can find it in Settings > General > Accessibility > Call Routing.

Track That

Also of interest to VoiceOver and braille users is a feature located in the Maps app called Tracking. Tracking will announce when you are approaching an intersection, and it will also provide the names of the cross streets. Tracking will also notify you of points of interest as you move about your environment.

To enable Tracking, launch the Maps app, and find the Tracking toggle located in the lower left corner of the touchscreen. Double tap this until it says "Tracking with Headings," and then begin walking.

This may be a difficult feature for braille-only users, because the announcements flash up on the display, and the user has no easy way to tell when new information is being presented. Also, it seems that Apple is still perfecting this feature, or perhaps it is designed to choose random points of interest, because Tracking will skip over some points of interest but announce others while the user is walking. Whatever the reason, it's nice to see this feature made accessible with VoiceOver, and I hope Apple continues to expand on it.

Conclusions

There are many changes in the way the operating system renders content, based on what is on or off for low vision users. I'd advise low vision users to check out iOS 8 at a retailer before upgrading, or perhaps find a friend who has upgraded, and check it out for themselves – particularly if they have not yet upgraded from iOS 6.

Low vision usage is a very personal thing, and what works for one person may not work for another. Braille and touchscreen users may want to check out the discussions and content on AppleVis.com, because there are a number of known issues with this new release that are not addressed in this review.

Additional Information

For more information, you can contact Scott at scott.davert@hknc.org.


Topics:
Web Accessibility
Reading
Assistive Technology
Low Vision
Online Tools
Technology

Avastin Injection Dosages Can Vary Significantly When Prepared by Compounding Pharmacies

Avastin vial

A new study has investigated the safety, sterility, and dosage consistency of Avastin, a lower-cost intravenous cancer drug that is used "off label," via eye injection, to treat a range of retinal disorders including age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.

The research concludes that a significant number of the Avastin study samples, which were prepared by pharmacists for eye injection through a process called "compounding," (explained below) contained significant variations in dosage, as well as lower active drug levels overall compared to Avastin obtained directly from the manufacturer.

From JAMA Ophthalmology

The research, entitled Evaluation of Compounded Bevacizumab [i.e., Avastin] Prepared for Intravitreal [i.e., within the eye] Injection, was published "online first" in the September 18, 2014 edition of JAMA Ophthalmology (formerly Archives of Ophthalmology). JAMA Ophthalmology is an international peer-reviewed journal published monthly by the American Medical Association.

The authors are Nicolas A. Yannuzzi, MD; Michael A. Klufas, MD; Lucy Quach; Lauren M. Beatty; Stephen M. Kaminsky, PhD; Ronald G. Crystal, MD; Donald J. D'Amico, MD; and Szilárd Kiss, MD, who represent the Departments of Ophthalmology and Genetic Medicine at Weill Cornell Medical College, New York.

Age-Related Macular Degeneration

In wet, or exudative, macular degeneration (AMD), 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).

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.

Diabetic Macular Edema

Diabetic macular edema [edema = a swelling or accumulation of fluid] (DME) can occur in people with diabetes when retinal blood vessels begin to leak into the macula, the part of the eye responsible for detailed central vision. These leakages cause the macula to thicken and swell, which, in turn, creates a progressive distortion of central vision.

Although this swelling does not always lead to severe vision loss or blindness, it can cause a significant loss of central, or detail, vision, and is the primary cause of vision loss in people with diabetic retinopathy.

Retinal Vein Occlusion and Macular Edema

A retinal vein occlusion (RVO) is a blockage [i.e., "occlusion"] of the small veins that carry blood away from the retina, the light-sensitive tissue that lines the inside surface of the eye. The retina converts incoming light into nerve signals and sends them to the brain, which interprets them as visual images.

Blockage of smaller, "branching," veins (a branch retinal vein occlusion or BRVO) in the retina often occurs when retinal arteries that have been thickened or hardened by atherosclerosis "cross over" and place pressure on a retinal vein. A branch retinal vein occlusion is sometimes referred to as "a stroke on the retina."

Anti-Angiogenic Drugs and Anti-VEGF Treatments

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 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. At present, these drugs are administered by injection directly into the eye after the surface has been numbed.

Avastin

Avastin is an anti-VEGF drug that is FDA-approved since 2004 for intravenous use in colorectal cancer. It is currently used on an "off-label" basis (i.e., via eye injection) to treat retinal eye disease.

Lucentis

Lucentis is derived from a protein similar to Avastin, specifically for injection in the eye to block blood vessel growth in AMD. In 2005, clinical trials first established Lucentis as highly effective for the treatment of wet AMD. The FDA approved Lucentis in 2006.

Eylea

Eylea was first approved by the FDA in late 2011 as an effective treatment for wet AMD. It is administered once every two months after three initial once-a-month injections.

Compounding Pharmacies

Avastin, unlike Lucentis and Eylea, does not come prepared in single-dose ready-made vials for eye injections because the FDA has not yet approved it for that purpose. Pharmacies, therefore, must compound (i.e., remix or prepare a single dose of) Avastin for eye injections from packaging that is intended for intravenous use. This has raised concerns about Avastin sanitation and sterility issues, as well as dosage accuracy.

In a recent study, which was conducted to determine if doctors approached macular degeneration differently when treating themselves, the authors concluded that the physicians surveyed in the study would recommend different treatments for themselves than they would for a patient. The study authors also noted the following:

In published results, [the authors] speculate that economics could be a factor. They report that the annual cost is estimated to be up to $23,400 for Lucentis, up to $14,800 for Eylea (8 doses), and about $595 for Avastin.

Physicians are more likely to have extensive health insurance and the financial means to afford more expensive drugs, the researchers explain.

"In contrast, physicians may prefer treatment with [Lucentis] or [Eylea] because of the safety profile, U.S. Food and Drug Administration (FDA) approval status, and the ability to obtain the drug from sources other than a compounding pharmacy," they write.

About the Research

Excerpted from Study Shows Inconsistent Dosages of Widely Used Eye Disease Drug: Findings Add to Public Health Debate About Pharmacy Compounding via the Weill Cornell Newsroom:

"Our evaluation showed significant differences in doses of compounded Avastin, as well as lower drug levels overall compared to Avastin that came from the manufacturer. This is troubling because the prescribed dosing regimen potentially won't produce the desired therapeutic response, or may put a patient's health at risk," said co-author Dr. Szilárd Kiss. "Although there were no signs of contamination, these findings raise legitimate concerns about the quality practices of compounding pharmacies."

Pharmacy compounding is the practice of creating customized, prescription medications to meet individual patients' needs. At the request of a physician or other healthcare provider who is authorized to write prescriptions, a licensed pharmacist alters ingredients in drugs, such as removing allergy-causing dyes or preservatives or preparing an alternative dosage form to make it easier for patients to take their medications.

In the study, researchers obtained three Avastin samples prepared in syringes from 11 compounding pharmacies from around the United States. Two samples from each pharmacy were tested for protein concentration (to measure the average amount of drug in the syringe), while the remaining 11 samples were tested for contaminants.

The researchers compared individual doses of compounded Avastin to samples obtained directly from the drug manufacturer, Genentech — formulations identical to those compounding pharmacies buy from the company to make eye injections. They found 17 samples with significantly less drug than the respective Genentech doses (and less than what was stated on the compounding pharmacy label), as well as one syringe that was completely empty, containing absolutely no medication at all.

The researchers also compared protein concentrations of the two samples from each pharmacy. They observed significantly different drug levels between the samples in three of 10 facilities. None of the samples tested positive for bacteria or other impurities.

Co-author Dr. Donald D'Amico said, "Although, reassuringly, all of the syringes in our study were contaminant-free, the wide variations in the Avastin doses in the various samples suggest that, in clinical practice, some patients who are 'non-responders' may simply have been under-dosed, and other patients may have received higher doses than recommended. Clearly, greater precision is needed to provide the best care for our patients," added Dr. D'Amico.

Compounders are licensed and regulated by their respective state boards of pharmacy, but a law passed in 2013 — the Drug Quality and Security Act — enforces new quality-control guidelines and increased federal supervision to guard against unsafe and sometimes illegal compounding practices.

More about the Study from JAMA Ophthalmology

From the article abstract:

Importance: [Avastin] acquired from compounding pharmacies for intravitreal injection may cause infectious and noninfectious inflammation. In addition to safety issues, the drug itself may have variable efficacy associated with product aliquoting [i.e., breaking it down into individual doses], handling, and distribution.

Objective: To conduct surveillance cultures, evaluate endotoxin [i.e., bacterial contamination] levels, and assess protein concentrations of [Avastin] obtained from compounding pharmacies in the United States.

Design and Setting: Prospective in-vitro study of syringes containing intravitreal preparations of [Avastin] from compounding pharmacies. This study was conducted at a university-based, good-manufacturing-practice facility and academic ophthalmology practice.

[Note: A prospective study measures a group of individuals or samples over time and follows up with them in the future.]

Results: There were no microbial contaminants or endotoxin detected in any of the samples. Of the 21 compounded samples of [Avastin] obtained from 11 pharmacies, 17 (81%) had lower protein concentrations … compared with [Avastin] acquired directly from Genentech. In 3 of 10 compounding pharmacies where more than 1 sample was available, there were statistically significant differences in the protein concentration between samples from the same compounding pharmacy.

Conclusions and Relevance: Test results from intravitreal preparations of [Avastin] acquired from compounding pharmacies were negative for microbial contaminants and endotoxin. However, there were significant variations in protein concentration that appear in general to be lower than [Avastin] acquired directly from Genentech. The clinical implications of these variable protein levels remain uncertain.

VisionAware will continue to report on Avastin compounding research as it becomes available.

Additional Information


Topics:
Medical Updates
Diabetes and diabetic retinopathy
Macular Degeneration
Avastin

What's New in iOS 8 Accessibility Part 1: Scott Davert, AppleVis Editorial Team

Scott Davert head shot

Guest blogger Scott Davert, M.A., VRT, is an AppleVis Editorial Team Member and a regional representative for the Region 8 Rocky Mountain area with the Helen Keller National Center for Deaf-Blind Youths and Adults.

Most recently, Scott compiled his personal picks for book-reading apps and iDevice apps that are user-friendly and accessible to braille, and also speech, users.

According to Scott, "As a power user of braille devices on iOS, it's very liberating to me, as a deaf-blind person, to be able to take full advantage of the technology we have in our society today. Just a decade ago, my access to resources was much more limited if braille was my only means of accessing the world. Today, with the help of technology, I can be just as well-informed about what's going on around me as my sighted and hearing counterparts."

This week, Scott is reviewing the new iOS 8 release from Apple, with an emphasis on accessibility features for individuals who are blind, deaf-blind, or have low vision. iOS is Apple's mobile operating system, or OS. Originally developed for the iPhone, it has since been extended to support other Apple devices, such as the iPod touch and iPad. In June 2010, Apple rebranded the iPhone OS as simply iOS.

About the iOS 8 Release

It's fall, which means that it's time for another iOS update for your iDevices – that is, if you are using an iPhone 4S or later, iPad 2 or later, or iPod Touch fifth generation or later. I, along with several AppleVis editorial team members, have been working with the beta versions of iOS 8 since its first build was released to developers in June.

This year, Apple is introducing many new mainstream features, including the ability to share purchased items with family members on joint accounts with the iTunes and App Store; further harmonization of iOS and OS X; interactive notifications; and WiFi calling. Since many mainstream sources will be covering these features in great detail, my review will focus on changes in accessibility.

Siri Updates

Hey, Siri!

If you've ever wanted to use Siri hands-free, you now have that ability in iOS 8. If you go into the settings for Siri (Settings > General > Siri), you will now find an option called Voice Activation. Turn this on, and you can talk to Siri without ever having to touch your phone. Since this feature is a tremendous battery drain, it is only active when your iDevice is plugged in to a power source; therefore, be sure to plug your phone in before you start talking.

Name That Song

Siri can now listen to a song that you're playing and tell you what it is. Just ask "What song is this?" and Siri will listen for a few seconds and then try to figure it out. If Siri can identify the song, it will tell you the name and artist – and then offer to let you buy the song on iTunes.

This is great for the times you're listening to a song on radio services or stations that don't provide accessible song information to listeners who are blind. It can also come in handy when you hear a song in a public place, such as a store or restaurant, that you can't identify.

VoiceOver Changes

I'll Take a New Voice, Alex

That's right – if you're running the iPhone 5S or newer (sorry, the 5C doesn't offer this), the iPad Air or newer, or the iPad mini with retina display or newer, you can now use Alex (from Mac OS X) as your default voice for VoiceOver.

This is a voice many users of the Mac have grown used to over the years, and many users will no doubt be happy to have it residing on their iDevices. This is also going to be a welcome addition for users who have both vision and hearing loss – with hearing loss in the higher frequencies, which makes understanding female voices more difficult.

You can find and download the Alex voice, which is not on by default, by going into Settings > General > Accessibility > VoiceOver > Speech > Dialect. Under the U.S. English heading, you will find the option to download and then use the Alex voice. Be sure you have plenty of space available, as this speech synthesizer weighs in at a hefty 900 megabytes. Also, it appears that after downloading the Alex voice for the first time, you must restart VoiceOver before using it.

And the Possibilities Keep Growing!

iOS 7 enabled you to download multiple enhanced-quality voices for both multi-language support and for access to other dialects or languages like English and Spanish. With iOS 8, you can now download enhanced-quality versions of voices on the fly [i.e., without reloading the application] if you are connected to WiFi.

Alex voice users can even add a second instance of U.S English as a dialect, which will give you the familiar Samantha voice which you can then switch to on the fly if Language is enabled in your rotor settings.

All of These Voices are Taking Up So Much Space – I Need a Disk Diet!

If you find that too many of the enhanced-quality voices are installed on your device, you can remove the ones you are not currently using. Once you have multiple voices added to your device, go to Settings > General > Accessibility > VoiceOver > Speech and you will find an edit button. There is a delete option next to each voice. Just double-tap, confirm your choice, and the voice will be removed, creating more space for other stuff.

Keep it Cranked!

A new rotor item, Audio Ducking, is available in iOS 8. No, activating this rotor option will not make VoiceOver sound like Donald Duck, but it will let you toggle Audio Ducking.

What is Audio Ducking, you ask? Audio Ducking is when iOS decreases the volume on whatever other audio is playing when VoiceOver is speaking. It has done this for quite some time, but now you can disable this feature if desired.

You can accomplish this by turning your rotor to Audio Ducking and flicking up or down with one finger. If Audio Ducking isn't in your rotor, head over to Settings> General > Accessibility > VoiceOver > Rotor, and then select the Audio Ducking option. Once selected, Audio Ducking will always be available in your rotor.

Is That the End?

Another minor – but welcome – change is that when you have reached the bottom of a page in, for example, Settings, VoiceOver will now announce "footer," quickly letting you know that you have reached the bottom of the current screen.

However, it is a bit sporadic, in the sense that VoiceOver now sometimes announces "footer" with certain blocks of text in Settings when there is more information beyond that point. This could be confusing to a new user, as the user may think he or she is at the end of a screen when they actually are not.

VoiceOver, No Longer Interrupted…Sort Of

Prior to iOS 8, when you were reading text (such as an e-mail or audiobook) using the Read All gesture, VoiceOver would interrupt whatever it was you were doing to let you know of notifications such as Twitter replies, Dice World rolls, and breaking news. This no longer happens, with the exception of text messages. So read away – just make sure no one texts you at the same time.

More E-Mail, More Options

In the Mail app, the Custom Actions option in the Rotor setting has been modified. Previously, when you were on a thread of messages in prior versions of iOS, Trash/Archive and More were your only options. Now, added to the list of custom actions and not requiring the selection of the More menu are Flag, Mark-as-Read/Unread, Archive, and – yes -- More.

The More menu now consists of Reply-All, Forward, Flag, Mark-as-Read/Unread, Move to Junk, Move Message, and Notify Me. The Notify Me option allows you to get push notifications when there is a reply to a specific message thread.

Typing

In addition to standard and touch typing for touchscreen input, there is now a new option called Direct Touch Typing. If you are in a text field and move to the Typing rotor option, you will still find the Standard Typing and touch Typing selections available.

Direct Touch Typing is similar to Standard Typing in that you can find a key with one finger, then tap another finger on the screen to enter the character. The difference with Direct Touch Typing is that if you touch a key and immediately lift your finger, that character is entered. If you're extremely confident in your ability to locate the key you want on your first try, Direct Touch Typing is for you.

You can also find the key you want by dragging a finger around the onscreen keyboard, then touching the same spot quickly to type that key. Typing feedback is, as with the other typing modes, based on the verbosity settings you have set in Settings > General > Accessibility > VoiceOver > Typing Feedback > Software Keyboards.

The Braille is Everywhere

The letter z represented in braille

Another new feature that has been added in to the rotor in iOS 8 is a built-in braille keyboard. This is similar to what users of the mBraille app have grown accustomed to, but without many of mBraille's advanced editing or shortcut features. However, this braille entry is now a universal keyboard option and works in any text field. You'll find it as a new rotor selection called Braille Screen Input.

Like the Handwriting mode that was introduced in iOS 7, you simply turn the rotor to the Braille option and begin typing in braille on the touchscreen. If you aren't finding this option in your rotor, you will need to enable it as described above in the Audio Ducking section.

Getting a Feel for Using the Braille Keyboard

  • To orient yourself to the braille dots, press and hold down a finger on the touchscreen until you hear two tones and the phrase "entering explore mode." Drag your finger around the screen to discover where the dots are. To exit this mode, simply lift your finger off the screen.
  • There are two keyboard layout modes: Tabletop and Screen Away. If you are not happy with the layout of your keyboard, try turning the screen in another direction to change the orientation. Note: If you have orientation locked, entering Braille Screen Input mode will disable that feature.
  • To change the input from or to contracted or uncontracted braille, flick three fingers to the right or left to change from one to the other. You can also find this feature under Settings > General > Accessibility > VoiceOver > Braille > Braille Screen Input.
  • After typing a word, flick right with one finger to enter a space. If you've made a mistake, flicking one finger to the left will perform a backspace.
  • If you flick up or down with one finger after inputting part or all of a word, you will be offered word suggestions based on common braille mistakes (such as "job" if you wrote "dob"). Flick up or down with one finger until you hear the word you want, then flick right with one finger to select that choice. (There's no need to double tap - that would just add two dots to your text.) Once you have chosen a word, you can continue inputting braille.
  • If you need to enter a new line, flick right with two fingers.
  • When you are done using braille as your input method, simply turn the rotor and all functionality of the touchscreen returns to normal – just as in Handwriting mode.
  • To search for an app on the Home Screen, when you type, iOS will pop up apps matching what you've typed so far; flick up and down to cycle through these, and two-finger flick right to open one.
  • Not a fan of entering your passcode with the touchscreen? No problem! You can also do this with braille gestures. Note: If the first character in your passcode is a number, you will need to first enter a number sign (dots 3-4-5-6) before typing your passcode. Once you are finished entering your passcode, the phone will unlock automatically.

It's important to note that 8-dot braille is only supported on the iPad, not the iPod or iPhone, due to the limited amount of touchscreen space available.

Also worthy of note is that performing a 6-dot gesture is a bit tricky, since Apple's touchscreen only permits five-finger gestures. As such, if you want to write a capitol Q in 8-dot braille, for example (dots 1-2-3-4-5-7), you need to lift a couple of fingers after pressing those dots, but not all, so that the system knows you are going to use other dots. The same scenario applies to writing a full cell in 6- or 8-dot mode.

What's New in iOS 8, Part 2

In Part 2 of his iOS 8 accessibility review, Scott discusses additional braille changes and updates for users with low vision. For more information, you can contact Scott at scott.davert@hknc.org.

More Information


Topics:
Reading
Assistive Technology
In the News
Technology

Meet Lorraine Keller, Ph.D. and My Mobile Light™ Low Vision Aid at Technical Vision, Inc.

Lorraine Keller, PhD

Lorraine Keller, Ph.D. is the CEO of Technical Vision, Inc., a medical equipment company specializing in the design and manufacture of quality personal assistive devices. Technical Vision's customers, many of whom are older adults, live every day with chronic, uncorrectable eye conditions. These conditions include macular degeneration, glaucoma, retinal disease, and age-related night blindness – conditions that can compromise personal safety and the ability to live independently.

Technical Vision's newest – and most innovative – product is My Mobile Light™ Low Vision Aid. My Mobile Light™ projects an intense, clear, ultra-bright LED light beam in a wide arc around the feet and in the immediate walking area. This additional lighting can help the user feel more secure, confident, and independent when walking from the bedroom to the bathroom at night or when traveling in unfamiliar locations outside the home. My Mobile Light™ also functions as a support cane to assist with gait and balance.

After a career of almost 20 years as a life sciences researcher at a large corporation, Dr. Keller "retired" and began a second career as an entrepreneur. Over the past 11 years, she co-founded four life sciences companies that develop products as diverse as gene therapies, immunotherapeutic cancer vaccines for humans, and a new oral drug for dogs and cats with cancer. Technical Vision, Inc. is Dr. Keller's first medical device company.

Maureen Duffy: Hello Dr. Keller. I am very excited to talk with you about the progress you've made in developing My Mobile Light™. To begin, can you tell us the history of this project? How did you initially envision the product and determine it was needed?

Lorraine Keller: Our goal was to create an effective, practical, and easy-to-use daily living aid for people with uncorrectable visual impairments such as age-related night blindness, glaucoma, retinitis pigmentosa, macular degeneration, and diabetic retinopathy, as well as other chronic conditions, like multiple sclerosis and Parkinson's disease.

Low vision impairs depth and color perception and the ability to judge distances, especially in poorly lighted environments. This can dramatically decrease a person's mobility. One of the greatest fears of people with vision loss is getting around safely at home and away without being injured by tripping or falling. Research has shown that the combination of low vision and low light doubles the risk falling and that fifty percent of falls occur at home, most often on level surfaces.

MD: Can you explain some of the features of My Mobile Light™? What makes it different from using a regular support cane and a flashlight, for example?

LK: My Mobile Light™ combines two different assistive concepts – bright lighting and mobility support – in a completely new way. My Mobile Light™ projects clear, even, bright light directly onto the ground around the user's feet and immediate walking area to illuminate obstacles on the floor or outdoor ground.

The support cane function assists with balance and gait, both of which are frequently impaired by vision loss and physical instability. My Mobile Light™ can help people overcome social and infrastructural barriers and enable them to more easily and independently carry out everyday activities that would otherwise be difficult, dangerous, or even impossible.

My Mobile Light graphic

Many people ask us "Why not just use a flashlight or headlamp with a cane?" There are several reasons. Flashlights require a separate hand for operation; a hand that's not available for carrying things, or holding a railing or grab bar. The light emitted by many flashlights is bluish, and not an optimal color for people with low vision. The light tends to be concentrated in a small, intense, and limited area only where the flashlight is pointed. The electronic circuitry in many flashlights causes the light intensity to decrease as the batteries are drained, so light gradually becomes dimmer and less useful.

As for headlamps, the light projects ahead of the traveler and not down around the feet where the immediate tripping hazards are. The wearer has to look down to aim the light, which increases the risk of losing his or her balance. Headlamp straps can cause headaches. And who wants to go out for an evening with family or friends sporting a light on the forehead?

MD: Can you tell us about the research you conducted as you field-tested My Mobile Light™?

LK: We designed and tested My Mobile Light™ under conditions that simulated the same night-time vision impairments and travel conditions that would be experienced by visually impaired users. The most profound experience for me was becoming completely sightless under low vision simulation in the dark – only then did I understand the degree of vision loss and disorientation in the absence of adequate lighting.

Those of us who are fully sighted can only appreciate the difficulties of navigating in low lighting with low vision by walking in the "other person's shoes," and those are the conditions we used to develop our product. We wore goggles that simulated 20/800 visual acuity and conducted our concept tests outdoors at night in suburban neighborhoods with cars, curbs, signposts, shrubbery, fallen tree limbs, and trash cans on and around the streets and sidewalks.

Our research identified the optimal light color, light intensity, and positioning of the light source most useful to the visually impaired user. This was a multidisciplinary collaboration: We worked with Dr. Audrey Smith, Professor and Dean of the Salus University College of Education and Rehabilitation and with professional engineers from IMET Corporation and MTS Ventures, bringing together expertise in low vision, LED lighting, electronics, and product design.

We began by researching how light and color perception are affected by different chronic eye conditions, and selected and tested several colors of LED lights from different color spectra to identify the optimal one for visually impaired eyes. IMET Corporation identified the LED and built special electronic circuitry to provide constant light output that does not gradually dim like a flashlight, and MTS Ventures created the final design that is practical and easy to use.

Shielding this tiny but intense light source is very important to direct the light to the walking area and to minimize glare to the user and people in the surrounding area.

My Mobile Light and descending stairs

Descending stairs with My Mobile Light™

My Mobile Light and ascending stairs

Climbing stairs with My Mobile Light™

MD: What is the difference between My Mobile Light™ and the long white cane that is part of a structured program of orientation and mobility instruction?

LK: My Mobile Light™ is an offset cane that offers gait and balance support. It is not a mobility cane, although we do have a prototype LED mobility cane waiting for a source of funds to develop. An offset cane handle is angled so that the hand grip falls directly over the cane tip or base. It offers better ergonomics and stability, since the person's full weight is centered over the cane shaft and base.

My Mobile Light™ is meant for use by individuals with mild to moderate low vision who also need gait and balance support – typically older adults.

MD: I understand you're in the midst of a major fundraising and manufacturing campaign right now. When will My Mobile Light™ be ready for distribution?

LK: We are still a very small company and have funded virtually all product development ourselves. I am delighted to say that we are in the process of manufacturing our first run of 200 My Mobile Light™ devices that will be ready for purchase online at Technical Vision, Inc in Fall 2014.

We are seeking "angel" investment to fund the next manufacturing run and to support company operations and product launch. We are currently running a crowdfunding campaign on CureFunders.com, a new site specializing in fundraising for healthcare companies.

MD: Where can readers locate more information about My Mobile Light™?

LK: Readers can visit our website at www.technicalvisioninc.com, where there is much more information about the My Mobile Light™ product, including a video demonstrating how the product works in dark environments. I also encourage readers to visit our blog, where we post informative and educational articles about vision impairment, falls prevention, and independent living.

MD: Do you have any new research and development projects on the horizon?

My Mobile Light cane

LK: We are planning several enhancements to My Mobile Light™. Chip-based technology makes it easy to incorporate many different safety and convenience functions into a single device for navigation and personal protection.

We are exploring some new concepts to assist with nighttime navigation in the home, and we also plan to use the LED and electronics technology in the My Mobile Light™ device in other products to help people with vision impairment navigate in low lighting.

Right now My Mobile Light™ is only available in basic black; we plan to add more colors and designs to our product line.

We thank Dr. Lorraine Keller for her support of VisionAware and for her research on behalf of blind and visually persons worldwide. You can find additional information on lighting and aging in place at There's No Place Like Home: Planning to Age in Place and Task or Directed Lighting on the VisionAware website.

More Vision Research

My Mobile Light™ images provided by Technical Vision, Inc. Used with permission.


Topics:
Low Vision
Orientation and Mobility
Getting Around

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