Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-06-30
2015-12-31
Brief Summary
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Detailed Description
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There are conflicting reports on the effectiveness of nutritional antioxidants in preventing or slowing the growth of age related cataracts, despite extensive laboratory evidence suggesting that oxidative damage to lens epithelial cells 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 and significantly decreased the risk of cataract.
Cataract formation following pars plana vitrectomy is a well recognized post-operative complication of the procedure, with the reported incidence of clinically significant cataract development as high as 80% within 2 years after pars plana vitrectomy.
INVESTIGATIONAL AGENT
Lenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients and anti-oxidants intended to be taken for the nutritional support of the human crystalline lens.
INTERVENTION
Participants will be randomized to treatment with Lenstatin or Placebo for (6) months following pars plana vitrectomy.
STUDY METHODS
Participants will have baseline nuclear density (cataract) measurements using the Pentacam Nucleus Staging (PNS) program. The Pentacam Scheimpflug imaging system is a non-contact and non-invasive anterior segment imaging device which has been shown to provide an immediate, quantitative, examiner-independent measurement of lens density which correlates with the LOCS III cataract grade. Serial Pentacam nuclear density measurements will be taken on each participant at (1) month intervals for (6) months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Lenstatin
Lenstatin (2) capsules orally per day for (6) months
Lenstatin
Dietary Supplement Lenstatin
Sugar Pill
Placebo manufactured to mimic Lenstatin (2) capsules orally per day for (6) months
Placebo
Placebo sugar pill manufactured to mimic Lenstatin
Interventions
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Lenstatin
Dietary Supplement Lenstatin
Placebo
Placebo sugar pill manufactured to mimic Lenstatin
Eligibility Criteria
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Inclusion Criteria
* Post pars plana vitrectomy surgery
Exclusion Criteria
* Pregnant women
* Hypersensitivity to any of the ingredients in Lenstatin
18 Years
ALL
No
Sponsors
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Lenstatin LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Scott W Tunis, MD FACS
Role: PRINCIPAL_INVESTIGATOR
Lenstatin LLC
Locations
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Scott W. Tunis MD FACS
Wilmington, North Carolina, United States
Countries
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Other Identifiers
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1-tunis
Identifier Type: -
Identifier Source: org_study_id