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SOURCE Lenstatin LLC
A Randomized Double-Blind Human Clinical Trial Evaluating the Efficacy of Lenstatin in Inhibiting Cataract Formation and Progression After Pars Plana Vitrectomy
WILMINGTON, N.C., May 22, 2014 /PRNewswire/ -- There are conflicting scientific reports on the effectiveness of nutritional antioxidants in preventing or slowing the growth of age related cataracts, despite extensive basic science research indicating that oxidative damage to the human lens is a common underlying etiologic factor in cataractogenesis. One reported review of nine clinical trials involving over 117,000 patients suggested that beta-carotene, Vitamin E, and Vitamin C had no effect in preventing or slowing the progression of age-related cataract.
Conversely, a randomized trial of over 14,000 US male physicians indicated that long-term daily multivitamin use modestly decreased the risk of cataract.
Lenstatin™ is the world's first proprietary formulated nutritional supplement containing 11 micronutrients and anti-oxidants which are targeted to support the health of the human crystalline lens in patients with early cataracts.
According to Principal Investigator Scott W. Tunis MD FACS, "Cataract formation is a well-recognized complication of pars plana vitrectomy surgery, with the reported incidence of developing clinically significant cataract within two years after the procedure as high as 80%. Cataracts occurring after pars plana vitrectomy are commonly of the nuclear type, similar in morphology to age-related cataracts. This study allows us to evaluate the efficacy of Lenstatin™ in preventing or inhibiting the progression nuclear cataracts over a significantly shorter interval of time than would be necessary for age-related cataracts, which may take decades to develop."
Subjects will be randomly allocated to treatment with Lenstatin™ or Placebo with treatment group identity concealed from the Investigator, participants, and data collectors. Cataract formation and progression will be compared between treatment groups using the Oculus Pentacam Nuclear Staging Program (PNS) which has been shown to provide an immediate, quantitative, and examiner-independent measurement of lens density which correlates reliably with LOCS III cataract grade. The study is registered with www.clinicaltrials.gov and is being conducted under IRB supervision.
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