May 23, 2017

Summary of Research and Developments–2017

Posted in: Daily Living, Latest News, Low Vision Rehabilitation, Research and Developments, Therapies, Treatments, and Procedures

Presentation to the International Low Vision Support Group
June 1, 2017
Dan Roberts

INTRODUCTION

This is my 12th annual summary of leading research and developments occuring during the past 12 months in the fields of blindness and low vision.

Sources for further information will appear beneath each topic heading, but for the sake of brevity, I will not read those sources aloud. Studies presented at the May 2017 meeting of the Association for Research in Vision and Ophthalmology are referenced as “ARVO”. All others are listed by date of publication in the News & Info section of this website. More information about each topic, along with references and sources, may be found there.

This year’s summary will offer brief descriptions of the work done in the categories of:

  • pharmaceutical treatments
  • combination therapies
  • sustained and extended drug delivery methods
  • non-pharmaceutical interventions
  • diagnostic procedures
  • daily living and rehabilitation
  • new technology

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PHARMACEUTICAL TREATMENTS FOR MACULAR DEGENERATION

For Some, Switching ANTI-VEGF Treatments Midstream Could Be Harmful
June 9, 2016

A small study suggests that some patients may have a negative response to switching from Lucentis to Eylea. The reason is unknown, but the study team thinks that a small number of people have a genetic variance which might be the cause. Fortunately, the worsening was found to be reversible after returning to Lucentis, with no significant loss of visual acuity. Doctors now need to be aware that a few patients may actually worsen, at which time corrective action can, and should, be taken before vision loss occurs.

Classification of strokes seen in patients receiving injections for neovascularization
ARVO
Posterboard #: A0071
Abstract Number: 892 – A0071
Author: Matthew Starr, et al 

Some literature has suggested that anti-VEGF injections for treatment of retinal blood vessel growth and leakage (neovascularization) may predispose patients to hemorrhagic stroke. Now, a retrospective review of 690 treated patients has found no predilection to the development of hemorrhagic or ischemic strokes in patients receiving anti-VEGF injections compared to patients in the era before anti-VEGF therapy became available. 39 of the 690 suffered a stroke within two years of their first injection, but this new research indicates that it may not be a result of the drug. 

Benefits of Aspirin Outweigh Risks in Age-related Macular Degeneration Patients
ARVO
Posterboard #: B0333
Abstract Number: 3200 – B0333
Author: Christine Garabetian, et al

Recent press releases regarding the potential adverse effects of aspirin on macular degeneration have caused patients with Age-related Macular Degeneration (AMD) to discontinue their aspirin use without consulting their physician. This study weighed the benefits that aspirin provides for patients’ cardiovascular health compared to the risk of AMD worsening.

After reviewing nine cardiovascular and ten ophthalmological studies and analyzing the risks/benefits of aspirin use, researchers found that the small and still unconfirmed added risk of AMD is far outweighed by the solid benefits of cardio-protective aspirin. Patients who are taking aspirin for cardiovascular health, therefore, should not fear the possible, theoretical and exaggerated risks of exacerbating their AMD.

A Promising Breakthrough For Dry AMD
July 27, 2016

Genentech, Inc., a leading pharmaceutical developer, is currently conducting two phase III trials studying the drug lampalizumab as a potential treatment for advanced dry macular degeneration, also known as geographic atrophy (GA).

If lampalizumab continues to show success, this could be a major breakthrough for GA patients, for whom there has been no previous treatment. The drug works by inhibiting Complement Factor D, a protein that is best known for its role in reducing infection. The Phase 2 study showed a 20.4 percent reduction in progression of advanced GA at 18 months. 

OHR-102 Trials Suspended
February 15, 2017

Ohr Pharmaceuticals has announced temporary suspension of a clinical study for its drug candidate, OHR-102 (previously known as Squalamine), an eye drop formulation which was also raising hopes as a treatment for wet macular degeneration. The company emphasizes that the suspension is not due to safety issues, and that they are still confident in the potential of the therapy.

Eye Drops Still Showing Positive Results
November 22, 2016

In spite of the unfortunate suspension of the Squalamine trials, eye drops continue to show promise as future treatments for wet AMD and other eye diseases involving neovascularization.

PAN-90806 is a topical eye drop for the treatment of neovascular AMD, diabetic retinopathy, and potentially diabetic macular edema (DME). Panoptica began phase 1 clinical trials in early 2014, and in 2015 the company reported that the monotherapy showed signs of safety and encouraging biological activity.

Lucentis® Approved for Myopic Macular Degeneration
January 6, 2017

Genentech has announced FDA approval for Lucentis® as a treatment for patients with neovascularization resulting from myopic macular degeneration (MMD), also known as myopic degeneration. Severe myopia (near-sightedness) can cause uncorrectable central vision impairment, and it may advance to total central vision loss from neovascularization. Lucentis is the first FDA-approved anti-VEGF therapy to treat myopic degeneration in the U.S.

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PHARMACEUTICAL TREATMENTS FOR OTHER CONDITIONS

Trials beginning for Emixustat Treatment of Stargardt Disease
January 27, 2017

Acucela has announced that the first patient has enrolled in a study to evaluate emixustat hydrochloride (“emixustat”) in subjects with Stargardt disease. 

Emixustat modulates the visual cycle by significantly reducing accumulation in the retina of a toxic by-product called A2E, which is believed to damage retinal cells. The drug has been in Phase 1/2 trials since 2008 for treatment of dry macular degeneration, and now a recent orphan drug designation by the FDA has opened the door for Stargardt disease to be included.

FDA Approves Lucentis® for Diabetic Retinopathy
April 17, 2017

As of April 2017 Lucentis has been approved by the FDA for the monthly treatment of both diabetic retinopathy and diabetic macular edema. In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.

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COMBINATION THERAPIES FOR NEOVASCULARIZATION

Fovista® Fails Final Test For Wet AMD Treatment
December 21, 2016

Fovista®, a once-promising experimental drug for treatment of wet macular degeneration, has failed to show positive results in Phase 3 trials. This is disturbing, since, on June 14, 2012, Ophthotech Corporation reported a 62% higher relative visual benefit when Fovista (1.5 mg) was used in combination with Lucentis in Phase 2b clinical trials.

The company expected to have positive top-line data from the clinical program available in 2016. The results, however, have shown no significant improvement in vision from the combination therapy compared with Lucentis injection alone.

ICON-1 
ARVO
Abstract Number: 3766
Author: Christine R. Gonzales, et al

Current anti-VEGF therapies for wet AMD reduce neovascularization but do not appear to reverse the progression of the disease. The EMERGE study examined the hypothesis that a new drug called ICON-1 can actually reverse the disease by blocking a protein called Tissue Factor (TF). When out of control, TF is thought to initiate inflammation and neovascularization. Repeated injections were well tolerated, and, when combined with Lucentis, visual acuity improved with fewer treatments. 

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SUSTAINED AND EXTENDED DRUG DELIVERY

Once-Promising Study of Encapsulated Cell Technology Halted
March 27, 2017

Encapsulated Cell Technology utilizes an implant into the eyeball genetically engineered to produce an anti-VEGF drug for at least 2 years. The capsule acts like a miniature factory for production and distribution of antiangiogenic and anti-inflammatory drugs in AMD patients long-term without the burden and risks of frequent injections.

Unfortunately, the drug produced by the capsule did not meet expectations at 24 weeks, so the study with AMD patients was halted. The researchers, however, note that ECT technology still holds promise as an effective and less invasive alternative to anti-VEGF injections, and that a similar study of people with another disease is still underway.

New Sustained Delivery Method for Lucentis
April 15, 2017

Genentech, Inc. is testing their own alternate delivery method for Lucentis. The new method utilizes a timed release capsule implanted into the eye, with a port to the exterior of the eyeball through which the drug is refreshed as needed. This sustained delivery method could extend the time between clinic visits by many months, greatly reducing the burden of frequent injections.

Sustained Delivery By Injectable Hydrogels
ARVO
Abstract Number: 2971
Author: Mark Tibbitt, et al

The goal of this study was to develop polymer-nanoparticle (PNP) hydrogels for sustained release of drugs and biotherapeutics over 6 months. Small molecule drugs were encapsulated into the nanoparticles and entrapped in hydrogels for injection into the eyeball. These drug-loaded PNP hydrogels then act as depots that can release therapeutics for up to a year, relieving  the burden of monthly intravitreal injections.

Another Hydrogel Ocular Drug Delivery System
ARVO
Abstract Number: 3767
Author: Wenqiang Liu, et al

Other reserchers have further validated the effectiveness of  a hydrogel delivery system by showing their method to be safe and capable of delivering Eylea in a controlled and extended manner. The purpose of this study was to validate a composite microsphere-thermoresponsive hydrogel drug delivery system (DDS) capable of releasing bioactive aflibercept in a controlled and extended manner.

None of these drug delivery systems have yet been tested in humans, but they all show promise of relief in the near future from the burden and risk of frequent injections for treatment of any neovascular eye disease.

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NON-PHARMACEUTICAL INTERVENTIONS

OpRegen® for Dry-AMD
March 13, 2017

OpRegen® is an investigational treatment for dry AMD, in which retinal pigment epithelial (RPE) cells are introduced into the subretinal space where they are intended to replace missing RPE cells. The RPE layer of the retina, you remember,  provides nourishment for the important photoreceptor (sight) cells. The therapy is in a Phase I/IIa clinical trial. So far, it has caused no serious adverse events, and researchers have reported that the transplanted cells have survived in the subretinal space for up to one year.

Photobiomodulation For Dry AMD
December 6, 2016

A new non-invasive technology called photobiomodulation is another therapy that may help improve vision in  people with dry AMD.

Photobiomodulation involves exposure of the retina to red, yellow, and infrared light waves. Researchers in Switzerland and Toronto recently found that treating eyes three times a week for three weeks improved best corrected visual acuity by up to 10 letters in 48% of the 24 subjects enrolled in the trial.

Contrast sensitivity and number and thickness of drusen (waste deposits in the retina) also improved, with the improvement lasting for three months. Additionally, no new development of geographic atrophy (advanced dry AMD) occurred during that period. 

Stem Cell Therapy

Effort continues to find good sources for stem cells, learn the best ways to convert them, and locate the most viable targets for transplantation. Such targets in the eye are the cornea, the lens, the sclera, and the epithelial and neuronal layers of the retina, with replacement of photoreceptor (sight) cells having become the newest focus. Research is being conducted worldwide, with nearly 60 currently listed as “active”  by the National Institutes of Health.

Combined Therapies May Help Restore Vision Loss From Glaucoma
September 10, 2016

Past studies have shown that high-contrast visual stimulation can help damaged retinal neurons regrow optic nerve fibers. By combining that knowledge with new research showing that increased activity of a protein called mTOR promotes optic nerve regeneration, scientists are hoping for a way to restore sight lost to glaucoma and other optic neuropathies.

Research on mice found that using gene therapy to increase the “expression” of mTOR in optic nerve damaged eyes significantly improved the efficacy of high-contrast visual stimulation. Within three weeks after the combined procedure, the axons grew about 500 times faster than those receiving visual stimulation alone.

Argus® II for Advanced Dry AMD
ARVO
Abstract Number: 4265
Author: Paulo E. Stanga, et al

The Argus II prosthesis, approved in 2013 for people with severe vision loss from retinitis pigmentosa, is now being considered for use by those affected by late stage dry AMD (geographic atrophy) with severe vision loss. The system works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. 

The Argus II has been providing a crude, but welcome, kind of vision for the seriously visually impaired, and now a study is underway to evaluate the functional benefit and safety of the system for people who have severe central vision loss, but still retain peripheral vision. After implantation, the system was found to effectively provide vision over the affected area in patients with geographic atrophy. And no patient reported confusion with the system on and both eyes open. A number of serious adverse events, however, suggest that improvements need to be made in the medication regimen, implantation technique, and/or implant design.

New Electronic Subretinal Implant Tested in Patients Blind from Inherited Retinal Dystrophies (RD)
ARVO
Abstract Number: 4266
Author: Eberhart Zrenner, et al

Another device that is restoring some sight  to the severely visually impaired is the Alpha AMS. This is a technically advanced subretinal electronic implant that is in multicenter trials to test its safety and efficacy. Psychophysical and subjective data show that the Alpha AMS implant is reliable, well tolerated and partially restores visual functions in the majority of patients. During the trials, it has been certified as a commercially available medical device in Germany, and centers have been recruited to provide it in several European countries. It is not approved for use in the United States.

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DIAGNOSTIC PROCEDURES

Non-Mydriatric Fundus Imaging
ARVO
Posterboard #: B0339
Abstract Number: 1867 – B0339
Author: Mehreen Adhi, et al

Single-field photography covering 20-50° of the back of the eye is traditionally used to evaluate retinal diseases. Now, Non-Mydriatic Ultra Wide Field (NM-UWF) imaging enables a wider field of view than traditional fundus photography, and it can be accomplished without the need for dilating the pupils. This allows better visualization of the peripheral retina than current non-mydriatic cameras, and it may be useful for tele-health screening and disease management programs. 

Call for Reduced Fundus Photos

Results from an online survey conducted by MD Support suggest that likely half of patients continue to endure fundus flash photography unnecessarily. The results imply that a number of patients with well-established diagnoses may still be needlessly undergoing routine high intensity light exposure.

 “Nowadays with the availability of . . . infrared imaging with the OCT device, said Janet Sunness, M.D. (Greater Baltimore Medical Center) there is only rarely a need for fundus photographs.”

MD Support predicts that “as more doctors make the transition to updated imaging options, and as even better methods are developed for quicker, safer, and less unpleasant techniques, a greater number of patients may start showing up for their important annual exams. This, in addition to the benefits to the clinical practice, could very well boost the success rates of early diagnosis and treatment.

Blue Light Decreases VEGF
ARVO
Posterboard #: B0451
Abstract Number: 5859 – B0451
Author : Melanie MARIE, et al

Blue light has been identified as a risk factor for AMD. Using a custom-made illumination system delivering blue and green waves, researchers recently confirmed that the narrow range 415-455 nm (the blue range) was the most toxic for at-risk RPE cells (the cells making up the retinal layer responsible for “feeding” the sight cells). 

The experiment showed that light exposure could modify the expression of the protein responsible for neovascularization at both the genetic level and the protein level. Surprisingly, the researchers found that harmful blue light tends to decrease the production of  the growth factor responsible for neovascularization. These results suggest that blue light toxicity might contribute more to the development of dry AMD than to the complications of wet AMD.

Annual Eye Exams For Retinopathy May Be Unnecessary For Some Type 1 Diabetics
April 24, 2017

Currently, patients who have had type 1 diabetes for 5 years are encouraged to have annual dilated retinal exams to look for possible progression to diabetic retinopathy (DR) or diabetic macular edema (DME). Both of these conditions can lead to severe vision loss and should be treated immediately.

Now, a 30-year study has shown significant benefits from customizing exam scheduling to each individual’s current state of retinopathy and glucose level. Researchers found that type 1 diabetes patients who had no retinopathy or macular edema at their initial screening had only a 5% probability of progressing to DR or DME over a period of 4 years. Relative to the patient’s condition, exams gradually increased to as often as 3 months for most severe cases.  With a practical, evidence-based schedule over a 20-year period, the frequency of exams was 58% lower than with routine annual exams.

Following this model of individualizing exam schedules, clinicians could significantly reduce the burden and cost of treatment. The change in protocol would require more effort in scheduling patients, but the trade-off in time and dollars could be worth the extra diligence.

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DAILY LIVING AND REHABILITATION

“How soon will my good eye go bad?”
January 22, 2017

This is commonly-asked by people affected with unilateral age-related macular degeneration (AMD). AMD is a chronic and progressive disease, and the chances are good that it will eventually affect both eyes. The question about when that will happen has been addressed by a three-continent study published in January 2017.

Researchers analyzed data from participants in three major studies, finding that after five years, 19-28% of  cases with all stages of AMD became bilateral, and 27-68% of those specifically with late AMD (geographic atrophy or neovascularization) became bilateral. In other words, about one in four (25%) people with any stage of AMD in one eye can expect it to progress to both eyes within about five years. If, however, a person has late AMD in one eye, the chance increases to one in two (50%).

In addition to identifying the time element, this study has reconfirmed the known risk factors significantly associated with progression to both eyes, with tobacco smoking currently being the only risk that can be eliminated or reduced.

The Value of In-Home Occupational Therapy
March 8, 2017

A new study has concluded that low-vision patients who improve in their daily living activities through at-home training with an occupational therapist have less severe symptoms of depression than similar patients who did not receive such training.

188 senior adults with low vision and borderline depressive symptoms were divided into an occupational therapy group and a supportive therapy group. The occupational therapy group met with an OT for six one-hour sessions in their homes. The supportive therapy group met with a social worker for six one-hour sessions of talk therapy. This group got attention and empathetic support, but not specific occupational therapy directed to improve their ability to function.

Four months after treatment, 26% of the supportive therapy patients reported that their depression symptoms worsened, while only 12% of the occupational therapy patients reported worsening symptoms. This is further science-based evidence that occupational therapy is effective in helping to maintain the quality of life of those affected by AMD, and, by extension, similar diseases of the retina leading to central vision loss.

Usage of Low Vision Rehabilitation Services
ARVO
Abstract Number: 1622
Author : Judith E. Goldstein, et al

This study estimated the prevalence of patients with low vision who obtain low vision rehabilitation services. It also compared their characteristics to individuals who do not access services. It found that, out of a total of  9,772 low vision patients, only about 15% utilized low vision services over the 12 month period. Low vision rehab participants were more likely to be female and older (67 vs 60 years old) than non-participants. In light of so many low vision patients not obtaining rehabilitation services, more attention needs to be paid to health care planning and developing interventions aimed at improving this opportunity to enhance visual ability and quality of life.

Positive effects of low vision rehabilitation
ARVO
Abstract Number: 4765
Author: Ruth M. Van Nispen, et al

To confirm the importance of participation in low vision rehabiliation, 120 visually impaired adults follow an annual weekday rehabilitation program to investigate its long term effectiveness on participation, vision-related quality of life, and mental health. Researchers found that, although some mental health outcomes and visual functioning did not improve, there was a strong long term positive effect of rehabilitation on participation, mobility, acceptance, and adaptation. 

Progression time to foveal loss in Geographic Atrophy
ARVO
Abstract Number: 2980
Author Block: Johanna Maria Colijn, et al

Geographic Atrophy (GA) is the end stage of the dry form of age-related macular degeneration. This causes blind areas in the central field of vision in people with macular degeneration who live long enough to experience it. 

A study was conducted on the long-term progression of GA and its effect on the fovea (the very center of the macula providing the most detailed vision). Researchers followed 62 eyes over a range of 1 to 12 years, concluding that GA first occurs mostly outside of the fovea, and the average time to reach the fovea is 5.8 years in people who live long enough. 

Yellow nighttime driving glasses
ARVO
Abstract Number: 4302
Author: Merve Tuccar-Burak, et al

Higher fatalities at nighttime mostly affect pedestrians. This has been presumed to be due to incoming headlight glare (HLG) reducing the visibility of pedestrians. As a solution to the problem, therefore, glasses with yellow lenses are advertised to help drivers see better at night and reduce the impact of HLG. Whether this is an effective solution to pedestrian detection was considered by a study measuring the impact of three such glasses on the response time for detecting a pedestrian both with and without HLG.

Researchers learned that yellow nighttime driving glasses did not improve pedestrian detection without HLG. With HLG, however, pedestrian detection was actually worse with the glasses than without the glasses. 

Eccentric viewing training for patients with AMD
ARVO
Abstract Number: 4766
Author: Gary Rubin, et al

Eccentric (“off-center”) Viewing Training (EVT) aims to teach people who have lost their central vision to use their peripheral vision to perform daily tasks like reading and recognizing faces. EVT is widely practiced in some European countries (especially Sweden), at some low vision centers in the US, and elsewhere. EVT is not generally available through the NHS in the UK. One reason it is not offered is the lack of evidence that EVT is effective. So researchers have tried to help close the gap in the evidence.

The trial recruited 200 patients with AMD and randomly selected 100 to receive EVT.  All 200 patients were followed for one year with a variety of vision tests and questionnaires, and the researchers are currently analyzing the data. First results, however, are in for the trial’s main outcome, which was to measure responses to a questionnaire on difficulty with daily visual activities. Indications are that those who received EVT did no better than those who did not. The researchers admit that those results are surprising, and that careful scrutiny is needed before they can decide whether EVT provides any benefit to patients with central vision loss.

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NEW TECHNOLOGY

Quiet Cars
November 16, 2016

The U.S. Department of Transportation is adding a sound requirement for all newly manufactured hybrid and electric light-duty vehicles to help protect pedestrians.

This will help prevent 2,400 pedestrian injuries a year by helping visually impaired pedestrians detect the presence, direction and location of these normally very quiet vehicles when they are traveling at low speeds.

Under the new rule, all hybrid and electric light vehicles with four wheels and a gross vehicle weight rating of 10,000 pounds or less will be required to make audible noise when traveling in reverse or forward at speeds up to 19 miles per hour. At higher speeds, the sound alert is not required because other factors, such as tire and wind noise, provide adequate audible warning to pedestrians.

Manufacturers have until Sept. 1, 2019, to equip all new hybrid and electric vehicles with sounds that meet the new federal safety standard. Half of new hybrid and electric vehicles must be in compliance one year before the final deadline.

Self-Driving Vehicles

And speaking of cars, self-driving (autonomous) vehicles are already demonstrating success on the road. Most new car manufacturers are including the technology in their cars in preparation for the laws to make full automation legal. So when the time comes, all they will have to do is activate those systems, and alternative transportation services will begin to undergo a dramatic change for the better. Experts are saying that we should see this happen in as soon as two to three years.

Electronic Readers

The most exciting new accessibility devices on the market today are an array of surprisingly accurate optical character recognition (OCR) systems. These are  devices that can read printed text aloud.

Initially, a printed document is photographed and scanned by a camera. OCR software then converts the images into recognized characters, and the synthesizer in the OCR system then speaks the recognized text. Once available only as a scanning machine connected to a computer with speech capability, the technology can now be found in every kind of device containing a lens, including eyeglasses, magnifiers, and smart phones. 

The KNFB Reader for smart phones, for example, has been available for several years at a very reasonable cost, and it is now available for desktop computers, as well.  

Amazon’s stand-alone Alexa assistant has also been incorporated into a variety of assistive technology devices. For low-vision people who may have lower levels of computer literacy, TrySight’s Aries Smart Reader is a simple-to-use device that has Alexa built in. Alexa support can also be found in Braille devices like NeoBraille.

Magnifiers

Of course, many varieties of portable and desktop magnifiers are on the shelves. This year they are sporting touch screens and higher-quality cameras. 

Indoor Positioning Systems

Like GPS, or geographic positioning systems that have been around for years, indoor positioning systems (IPS) are quickly becoming available in public venues to help visually impaired people with smart phones to find their way around inside of buildings. This past year has seen a sizeable growth in the business, and MD Support has been one of the most active providers–donating its specially-designed IPS service, called LowViz Guide, to more than a dozen low vision conventions across the country this past year. Those who have experienced it are looking forward to finding systems like it soon in every public venue.  

New Object and Facial Recognition Devices

Object and facial recognition software has been around for awhile, most notably since the introduction of the Orcam headworn system in 2013. Now two new developments are worth watching.

Carnegie Melon Robotics Institute has developed its own IPS platform, called NavCog, but they are supplementing it with their work in robotics by adding facial and activity identification capabilities. In total, they call it Cognitive Assistance.

In the not-too-far-off future, visually-impaired users with mobile devices will not only be able to learn about their surroundings and get guidance, they will be able to identify objects within view, and they will know who is passing by, how they are feeling, and what they are doing. This would be the ultimate in accessibiity, but we will have to wait a little while longer for it to reach the public. 

In the meantime, a brand new iPhone application called Aipoly works in conjunction with any smartphone’s camera to recognize and vocalize objects and colors. It can recognize over a thousand items immediately, and it can speak several languages. 

Look for more such devices in the future, as the world of technology continues to expand exponentially on behalf of the low vision community.

Links directory for dealers in assistive technology products

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CONCLUSION

This concludes my 2017 summary of research and developments. It has been another year full of news about ambitious work being accomplished on behalf of the low vision community. Sometimes it seems that things are moving too slowly, which may be true in some areas, especially where more funding is needed; but when taking in a helicopter view like this, the totality of effort can be impressive. I hope you find this past year’s news encouraging, and that you will continue to have faith in the thousands of researchers, developers, and care providers who are working diligently on our behalf. 

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