FDA clears iPhone vision test

The FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. 

The software, called myVisionTrack, was developed by Vital Art and Science. The FDA clearance applies to the software when run on an iPhone 4S.

Vital Art and Science has developed the test for patients with serious degenerative eye conditions such as diabetic retinopathy (DR) and age-related macular degeneration (AMD), who will be able to use it to monitor their vision regularly at home. The software compares results to previous results, and can automatically alert a physician if a significant change has occurred, so the physician can respond with an appropriate therapy in a timely way. As the product is developed, the company also plans to enable it to send patients’ results to their EHRs in a safe, HIPAA-compliant way.

According to President Mike Bartlett, the company hopes to have a downloadable app version of the platform eventually. But because the software is only currently cleared for prescription use, the initial form factor will probably be to distribute pre-loaded iPhones to patients.

“Right now we’re looking for collaboration opportunities like clinical drug trials,” he told MobiHealthNews. “In all of the clinical drug trials [for degenerative eye diseases], all of the data is being collected in the clinic. We want to enable them to collect data as often as hourly or daily instead of every month or so. Because of the nature of vision problems, we expect the first big deployments will be done by the drug companies.”

The company is already in talks with Novartis, makers of Lucentis, which is prescribed for DR and AMD. Novartis funded a clinical trial of myVisionTrack. Bartlett hopes the software will be prescribed along with drugs like Lucentis and paid for by patients’ health plans.

The app runs a test called shape discrimination hyperacuity (SDH), which is licensed from the Retina Foundation of the Southwest, whose research showed it to be one of the most likely vision tests to work on an electronic device. This is partly because, unlike the famous Snelling test typically used in opthamologist offices, the SDH is distance insensitive, which means patients using it at home can hold it at any natural distance from their faces without effecting the accuracy. In two different clinical trials, Vital Art and Science found the test to be equal to or better than a Snelling test in terms of accuracy. In the test, patients are repeatedly presented with three shapes and have to tap the one that looks different.

Bartlett believes over-the-counter clearance is something that will come along for diagnostic apps, once they’ve become more commonplace.

“We felt from the beginning we wanted to develop the regulatory approved version,” said Bartlett. “The one that’s going to be used and trusted by doctors.”

By: Jonah Comstock | Apr 8, 2013

November is Diabetic Eye Disease Awareness Month

An Article from the Lebanon Journal, Lebanon PA   Nov 2012

An estimated 25 million Americans currently have diabetes, according to the United States Centers for Disease Control and Prevention. Unfortunately, rising rates of diabetes have contributed to a sharp increase in diabetic eye diseases and blindness. To raise awareness about this serious threat to healthy vision, the Pennsylvania Academy of Ophthalmology is urging all diabetic patients in Pennsylvania to obtain regular eye exams during November, Diabetic Eye Disease Awareness Month.

The most common diabetic eye disease is diabetic retinopathy, which affects 40 to 45 percent of Americans with diabetes according to the National Eye Institute. Diabetic retinopathy damages the delicate blood vessels inside the retina at the back of the eye. Damaged blood vessels in the retina may leak extra fluid and small amounts of blood or fat deposits into the eye. As the disease progresses, abnormal blood vessels can grow on the surface of the retina or optic nerve, which can lead to blindness. Diabetic patients are also at an increased risk for cataracts and glaucoma.

Diabetic eye diseases typically have no early symptoms, so regular eye exams with an ophthalmologist - an eye medical doctor - are paramount to help monitor eye health and preserve diabetic patients' vision. Once diagnosed, an ophthalmologist can help slow the progression of the disease.

Too often, diabetic eye disease progresses into blindness because patients don't get their annual eye health screenings. Early detection and treatment is critical to reduce and delay severe vision loss in diabetics.

To maintain healthy vision with diabetes, ophthalmic professionals recommend the following EyeSmart tips:

Get a comprehensive dilated eye examination at least once a year.

Control your blood sugar.

Maintain healthy blood pressure and cholesterol levels.

Exercise regularly.

Quit smoking, or never start.

As diabetic retinopathy progresses, symptoms may include specks or spots floating in the visual field, blurred central vision, vision that changes from blurry to clear, poor night vision, and vision loss. Treatments to slow the progression of diabetic retinopathy include injectable and oral medications, laser surgery and vitrectomy surgery.

Diabetes Control and Eye Exams

The occurrence of Diabetes is rapidly increasing in the United States. It has been estimated that there will be more than 30 Million diabetics in the U.S. by 2030, and there are presently 23 Million. In addition, another 57 million people are considered to have prediabetes, meaning that their blood sugar is not normal but not quite abnormal enough to make a diagnosis. Diabetes has many complications associated with it like increased heart disease, stroke risk, and a loss of sensation in your limbs causing difficulty walking. Here at Skyvision, of course, we are engaged every day in the fight against blindness caused by Diabetes.

Diabetes remains a major cause of blindness in all age groups. Diabetic retinopathy consists of abnormal blood vessels which occur where they do not belong. In time these blood vessels can leak causing swelling. The also break and bleed, sometimes filling the eye up with blood. The bleeding often causes a kind of scarring which can lead to a retinal detachment. The most effective treatment is to PREVENT DIABETIC RETINOPATHY from ever happening. Once it occurs, the treatment of all types of diabetic retinopathy is much more successful if it starts early.

Do you have diabetes? If so, what can you do to prevent yourself from going blind? There are two well-studied things you should do. First, and this is really easy, make sure you have an eye exam every year. This exam should include eyedrops that dilate your pupil. Your eye doctor should then explain any findings, and a letter should be sent to your diabetes doctor.

The other thing you can do is keep your diabetes under control! The measurements that are the most important are your morning fasting sugar level, and your Hemoglobin A1c (HbA1c). The safest levels according to the most recent research are a fasting sugar of 100 or below, and an HbA1c or 6.0 or lower. Your risk of diabetic retinopathy goes up by a factor of 2.5--it more than doubles--if your fasting sugars are over 108. The same holds true for your HbA1c: your risk more than doubles with a value of 6.5 rather than 6.0.

Do you have diabetes? Get an annual eye exam. Know your morning fasting sugar levels. Ask your doctor what your Hemoglobin A1c is. You CAN prevent diabetic retinopathy!

Diabetes and the Eye

The occurrence of Diabetes is rapidly increasing in the United States. It has been estimated that there will be more than 30 Million diabetics in the U.S. by 2030, and there are presently 23 Million. In addition, another 57 million people are considered to have prediabetes, meaning that their blood sugar is not normal but not quite abnormal enough to make a diagnosis. Diabetes has many complications associated with it like increased heart disease, stroke risk, and a loss of sensation in your limbs causing difficulty walking. Here at Skyvision, of course, we are engaged every day in the fight against blindness caused by Diabetes.

Diabetes remains a major cause of blindness in all age groups. Diabetic retinopathy consists of abnormal blood vessels which occur where they do not belong. In time these blood vessels can leak causing swelling. The also break and bleed, sometimes filling the eye up with blood. The bleeding often causes a kind of scarring which can lead to a retinal detachment. The most effective treatment is to PREVENT DIABETIC RETINOPATHY from ever happening. Once it occurs, the treatment of all types of diabetic retinopathy is much more successful if it starts early.

Do you have diabetes? If so, what can you do to prevent yourself from going blind? There are two well-studied things you should do. First, and this is really easy, make sure you have an eye exam every year. This exam should include eyedrops that dilate your pupil. Your eye doctor should then explain any findings, and a letter should be sent to your diabetes doctor.

The other thing you can do is keep your diabetes under control! The measurements that are the most important are your morning fasting sugar level, and your Hemoglobin A1c (HbA1c). The safest levels according to the most recent research are a fasting sugar of 100 or below, and an HbA1c or 6.0 or lower. Your risk of diabetic retinopathy goes up by a factor of 2.5--it more than doubles--if your fasting sugars are over 108. The same holds true for your HbA1c: your risk more than doubles with a value of 6.5 rather than 6.0.

Do you have diabetes? Get an annual eye exam. Know your morning fasting sugar levels. Ask your doctor what your Hemoglobin A1c is. You CAN prevent diabetic retinopathy!