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The Post-Vitrectomy Lenstatin™ Study

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ClinicalTrials.gov Identifier: NCT02131194
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Lenstatin LLC

Brief Summary:
To determine the efficacy of Lenstatin™, an over-the-counter nutritional supplement, in inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.

Condition or disease Intervention/treatment Phase
Cataract, Nuclear Progressive Dietary Supplement: Lenstatin Drug: Placebo Not Applicable

Detailed Description:

BACKGROUND AND RATIONALE

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Post-Vitrectomy Lenstatin Study: A Prospective Randomized Double Blind Human Clinical Trial Testing the Efficacy of Lenstatin in Inhibiting Cataract Formation and Progression After Pars Plana Vitrectomy
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Lenstatin
Lenstatin (2) capsules orally per day for (6) months
Dietary Supplement: Lenstatin
Dietary Supplement Lenstatin

Placebo Comparator: Sugar Pill
Placebo manufactured to mimic Lenstatin (2) capsules orally per day for (6) months
Drug: Placebo
Placebo sugar pill manufactured to mimic Lenstatin




Primary Outcome Measures :
  1. Pentacam Nuclear Density Measurements [ Time Frame: (6) months ]
    The endpoint for determining the efficacy of Lenstatin in inhibiting cataract growth is a 95% confidence level of a statistically significant greater than 5% reduction in the rate of of increase in Pentacam nuclear density measurements in the Lenstatin™ treatment group compared to the placebo treatment group at 6 months postoperative pars plana vitrectomy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults over the age of 18
  • Post pars plana vitrectomy surgery

Exclusion Criteria:

  • Pediatric patients under the age of 18
  • Pregnant women
  • Hypersensitivity to any of the ingredients in Lenstatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131194


Locations
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United States, North Carolina
Scott W. Tunis MD FACS
Wilmington, North Carolina, United States, 28405
Sponsors and Collaborators
Lenstatin LLC
Investigators
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Principal Investigator: Scott W Tunis, MD FACS Lenstatin LLC

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Responsible Party: Lenstatin LLC
ClinicalTrials.gov Identifier: NCT02131194     History of Changes
Other Study ID Numbers: 1-tunis
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015

Keywords provided by Lenstatin LLC:
Cataract
Nutritional Supplement

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases