US FDA approves artificial iris

The United States Food and Drug Administration has approved the first stand-alone prosthetic iris in the US, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition aniridia or other damage to the eye.

The device was developed by HumanOptics AG, a medical technology company based in Erlangen, Germany.
“Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye,” Dr Malvina Eydelman, MD, director of the division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said.

‘Novel method to treat iris defects’

“Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”
Congenital aniridia is a rare genetic disorder in which the iris is completely or partially absent. It affects approximately 1 in 50,000 to 100,000 people in the US.

In addition to congenital aniridia, the CustomFlex Artificial Iris is indicated to treat iris defects due to other reasons or conditions, such as albinism, traumatic injury or surgical removal due to melanoma.
The artificial iris is made of thin, foldable medical-grade silicone and

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By | June 11th, 2018|Research Results|

Journals under scrutiny over random trials

ANALYSIS of more than 5,000 supposedly randomised trials, including in big names such as the Journal of the American Medical Association and the New England Journal of Medicine, has uncovered dozens in which the baseline data clearly is not random.

  • The study, by English anaesthetist and renowned fraud hunter Dr John Carlisle, could lead to dozens of papers being retracted.
  • The analysis points to a need for screening of trials not only before they are published but also going back decades.
  • A major question now is what to do with intelligence about researchers who appear to be misinterpreting or fudging their data.

The new study, published in the journal Anaesthesia, applied a mathematical screening tool to 5,087 randomised, controlled trials published inn six anaesthetic and two general medical journals.

Dr Carlisle used a computer program designed to spot statistical inaccuracies to uncover the fraud of serial fabricator Dr Yoshitaka Fujii, a Tokyo-based anaesthetist, who holds the world record for most retractions by a single author after having 183 publications withdrawn.

Later, Dr Carlisle teamed up with University of Sydney anaesthetist Dr John Loadsman to point the figure at Dr Fujiis’ collaborator, Dr Yuhji Saitoh.

Now Dr Carlisle is applying the method to many papers, rather than focusing on individual researchers, investigating the distribution patterns

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By | July 3rd, 2017|Research Results|

Study in United States suggests experimental gene therapy is safe for use in humans

Researchers at the United States’ Johns Hopkins University School of Medicine and their collaborators have shown that an experimental gene therapy that uses viruses to introduce a therapeutic gene into the eye is safe, and that it may be effective in preserving the vision of people with wet aged macular degeneration.

The study, published in The Lancet on 17 May, reports a new approach in which a virus, altered in the laboratory so that it is unable to cause disease, is used as a carrier for a gene and is injected into the eye.

The virus penetrates retinal cells and deposits a gene, which turns the cells into factories for production of the therapeutic protein sFLT01.

The phase 1 clinical trial involved 19 men and women, 50 years old or older with advanced wet AMD.

Professor Peter Campochiaro, MD, the George and Dolores Eccles Professor of Ophthalmology at Johns Hopkins, said, “This preliminary study is a small but promising step towards a new approach that will not only reduce doctor visits and the anxiety and discomfort associated with repeated injections in the eye, but may improve long-term outcomes because prolonged suppression of VEGF is needed to preserve vision, and that is difficult to achieve with repeated injections.”

By | June 12th, 2017|Research Results|

Indigenous people over 40 have 3 times rate off blindness: first national report on their eye health

Indigenous people (Aboriginal and Torres Strait Islanders) in Australia have three times the rate blindness of non-Indigenous people, the first national report on Indigenous eye health has found.

The report ‘Indigenous eye health measures 2016’, was produced by the Australia Institute of Health and Welfare, and was published on 30 May.

The report compiles data from a range of sources and presents findings at the national, state and regional levels.

Its major findings are:

  • In 2016 the prevalence of bilateral vision impairment for Indigenous Australians aged 40 and over was 10.5% and the prevalence of bilateral blindness was 0.3% (both affecting an estimated 18,300 Indigenous Australians aged 40 and over).
  • The 3 leading causes of vision impairment for older Indigenous adults were refractive error (63%), cataract (20%) and diabetic retinopathy (5.5%).

Trachoma infection down 10% in 6 years

  • Repeated untreated trachoma infections are a cause of vision loss in some remote Indigenous communities, but the prevalence of active trachoma in children aged 5–9 in at-risk communities fell from 14% in 2009 to 4.6% in 2015.
  • The age-standardised proportion of Indigenous Australians who had had an eye examination by an eye-care professional in the preceding 12 months increased from 13% in 2005–06 to 15% in 2014–15.
  • There were 6,404 hospitalisations (4.5 per 1,000) of Indigenous

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By | June 6th, 2017|Research Results|