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Study: Bionic Eye Safely Restores Vision PDF
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Ophthalmology and Optometry
Tuesday, 30 June 2015

Argus II patientThe three-year clinical trial results of the retinal implant popularly known as the "bionic eye", have proven the long-term efficacy, safety and reliability of the device that restores vision in those blinded by a rare, degenerative eye disease. The findings show that the Argus II significantly improves visual function and quality of life for people blinded by retinitis pigmentosa. They were published online recently in Ophthalmology, the journal of the American Academy of Ophthalmology.

The Argus II system was designed to help provide patients who have lost their sight due to retinitis pigmentosa with some useful vision. Through the device, patients with retinitis pigmentosa are able to see patterns of light that the brain learns to interpret as an image. The system uses a miniature video camera stored in the patient's glasses to send visual information to a small computerized video processing unit which can be stored in a pocket. This computer turns the image to electronic signals that are sent wirelessly to an electronic device implanted on the retina, the layer of light-sensing cells lining the back of the eye.

The Argus II received the US Food and Drug Administration (FDA) approval as a Humanitarian Use Device (HUD) in 2013, which is an approval specifically for devices intended to benefit small populations and/or rare conditions.

To further evaluate the safety, reliability and benefit of the device, a clinical trial of 30 people, aged 28 to 77, was conducted in the United States and Europe. All of the study participants had little or no light perception in both eyes. The researchers conducted visual function tests using both a computer screen and real-world conditions, including finding and touching a door and identifying and following a line on the ground. A Functional Low-vision Observer Rated Assessment (FLORA) was also performed by independent visual rehabilitation experts at the request of the FDA to assess the impact of the Argus II system on the subjects’ everyday lives, including extensive interviews and tasks performed around the home.

The visual function results indicated that up to 89 percent of the subjects performed significantly better with the device. The FLORA found that among the subjects, 80 percent received benefit from the system when considering both functional vision and patient-reported quality of life, and no subjects were affected negatively.

After one year, two-thirds of the subjects had not experienced device- or surgery-related serious adverse events. After three years, there were no device failures. Throughout the three years, 11 subjects experienced serious adverse events, most of which occurred soon after implantation and were successfully treated. One of these treatments, however, was to remove the device due to recurring erosion after the suture tab on the device became damaged.

New Device Approved to Assist the Blind Process Visual Signals with Their Tongues PDF
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Ophthalmology and Optometry
Tuesday, 23 June 2015

Brainport v100Last week, The U.S. Food and Drug Administration (FDA) gave green light for marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.

The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

"Medical device innovations like this have the potential to help millions of people,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”

The FDA reviewed the data for the BrainPortV100 through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

Clinical data supporting the safety and effectiveness of the BrainPort V100 included several assessments, such as object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Studies showed that 69 percent of the 74 subjects who completed one year of training with the device were successful at the object recognition test. Some patients reported burning, stinging or metallic taste associated with the intra-oral device. There were no serious device-related adverse events.

Scientists Discover Mechanism That Leads to Dry Eye Discomfort PDF
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Ophthalmology and Optometry
Wednesday, 17 June 2015

Dry Eye DiseaseA group of researchers from the Instituto de Neurociencias, a mixed center of the Miguel Hernández University of Elche (UMH) and the Spanish National Research Council (CSIC), has taken part in a study on the origin of the symptoms of dry eye disease. The work, which explains the molecular mechanism leading to the discomfort that causes this disease, has been published in the journal Nature Communications.

Dry eye is the most common eye disease in the world, and especially so in older people. It is caused by disorders in the quantity and quality of tears, and leads to continuous eye pain and irritation, increased blinking and altered vision, and can potentially cause blindness. UMH Professor Carlos Belmonte explained that "until now we knew that the nervous system is sensitive to increases in the concentration of salts that in turn causes decreases in the volume of tears of dry eye disease, but we did not know the molecular mechanism responsible for the excitation of these nerves."

Instituto de Neurociencias researcher Félix Viana added that "we have worked with genetically modified mice to suppress the action of the TRPM8 protein, which is present in the nerve fibers of the eye surface, and we have been able to confirm that, under similar conditions of salt concentrations in tears, our mice blinked less than the mice that had not subjected to this genetic modification."

"We believe the TRPM8 protein is that responsible for the nerve signals reaching the brains in persons with dry eye and they cause increased blinking and sensation of pain," concluded Andrés Parra. Currently, he is a postdoctoral researcher at the Max Planck Florida Institute for Neuroscience (USA), and will return to the Instituto de Neurociencias in the coming months.

The work was done in collaboration with the Wolfson Centre for Age-Related Diseases of King’s College London (United Kingdom) and forms part of ongoing research on dry eye at the Sensory transduction and nociception and Ocular neurobiology units of the Instituto de Neurociencias.

Eye Testing App As Good As Visual Acuity Charts PDF
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Ophthalmology and Optometry
Thursday, 11 June 2015

Peek AppAn app to test eyesight easily and affordably using a smartphone is as accurate as traditional charts, according to a study published recently. Peek (the Portable Eye Examination Kit) is a unique smartphone-based system for comprehensive eye testing anywhere in the world which has been designed and developed by the London School of Hygiene & Tropical Medicine, the University of Strathclyde and the NHS Glasgow Centre for Ophthalmic Research.

Globally, 285 million people are visually impaired and 80% have diseases which could be cured or prevented. However, most live in low-income countries and remain in the dark because of limited access to specialist clinics. Peek offers a solution by enabling health workers to test eyes easily and affordably in the community.

The research, published in JAMA Ophthalmology, shows that the results from the app tests carried out on 233 people in their own homes and repeated in eye clinics based in Kenya were as reliable as those from standard paper-based charts and illuminated vision boxes in an eye clinic. The app vision test is designed not to be dependent on familiarity with symbols or letters used in the English language. Tests in patients' homes found that Peek Acuity produced results to a clinical level equivalent to the much larger and more expensive standard electricity dependent chart - the average difference being the equivalent of less than one line on an eye chart.

Lead author Dr Andrew Bastawrous, Lecturer in International Eye Health at the London School of Hygiene & Tropical Medicine and co-founder of Peek, was struggling to transport bulky eye equipment to remote areas in Kenya when he decided to try to create a future replacement for the equipment with a phone-based testing system during a six-year follow-up of the Nakuru Eye Disease Cohort. The Peek validation study was nested within this community study between December 2013 and March 2014.

Researchers Find Ebola in Patient's Eye Fluid After Weeks Undetectable in Blood PDF
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Ophthalmology and Optometry
Wednesday, 10 June 2015

Ebola EyeOn May 7, researchers gave the first public presentation of a case study in which viable Ebola virus was present in the eye's aqueous humor -the clear fluid in the front of the eye, between the lens and the cornea - 10 weeks after the virus was no longer detectable in the patient's blood. The case study is based on Ebola survivor Ian Crozier, MD. Crozier and four of the physicians who treated him at Emory University Eye Hospital presented the findings at the annual meeting of the Association for Research in Vision and Ophthalmology.

Ian Crozier, an infectious disease specialist, helped in the fight against the Ebola outbreak in Sierra Leone in August 2014. Within a few weeks, he himself contracted the disease and was evacuated to Emory University Hospital in Atlanta in critical condition.

After he recovered from Ebola virus disease, Crozier was found to have severe uveitis during his convalescence. Uveitis is an inflammation of the uvea, the middle layer of the eye, which contains many of the eye's blood vessels. The resulting swelling can destroy eye tissues, leading to reduced vision and even severe vision loss.

According to Steven Yeh, MD of the Emory Eye Center, "The presence of viable Ebola virus in the eye could mean that other Ebola survivors may also be at risk for the development of uveitis. The thousands of Ebola survivors in West Africa and health care workers in their home countries will need to be monitored for eye disease in the post-Ebola period."

Study Reveals Contact Lens Wearers May Have Different Eye Bacteria PDF
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Ophthalmology and Optometry
Thursday, 04 June 2015

Contact LensUsing high-precision genetic tests to differentiate the thousands of bacteria that make up the human microbiome, researchers at New York University (NYU) Langone Medical Center suggest that they have found a possible and potentially surprising root cause of the increased frequency of certain eye infections among contact lens wearers.

In a study report on their work presented at the annual meeting of the American Society for Microbiology on May 31 in New Orleans, NYU Langone researchers say they have identified a diverse set of microorganisms in the eyes of daily contact lens wearers that more closely resembles the group of microorganisms of their eyelid skin than the bacterial grouping typically found in the eyes of non-wearers.

Specifically, the researchers found that the eye surface, or conjunctiva, has surprisingly higher bacterial diversity than the skin directly beneath the eye and three times the usual proportion of Methylobacterium, Lactobacillus, Acinetobacter, and Pseudomonas bacteria in the eyes of the study’s nine contact lens wearers than is typically found on the surface of the eyeballs of 11 other men and women in the study who did not wear contact lenses. When measured and plotted on a graph, statistical germ diversity scores showed that the eye microbiome of contact lens wearers had a composition more similar to that of the wearer’s skin than the eye microbiome of non-lens wearers.

As part of the study, researchers took hundreds of swabs of various parts of the eye, including the eye conjunctiva, as well as along the skin directly beneath the eye. Both swabs and used contact lenses were then subjected to genetic analysis in the lab to determine which bacteria were present.

While the bacterial composition in the eye of contact lens wearers more closely resembled that of the skin, some 5,245 distinct bacterial strains and subtypes were identified in the eye conjunctiva of lens wearers, and 5,592 strains were identified in the eyes of non-lens wearers. A similar but different composition of 2,133 strains and subtypes were identified in the skin directly beneath the eye of those with contact lenses, while 3,849 distinct bacteria were identified in non-lens wearers.

Surprisingly, researchers say, more Staphylococcus bacteria, which are linked to eye infections and more prominent on the skin, were found in the eyes of non-lens wearers, and researchers do not yet have an explanation for the disparity. Estimates vary, but many cases of potentially scarring bacterial keratitis, or eye inflammation, as well as conjunctival infections occur in contact lens wearers.

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