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The Post-Vitrectomy Lenstatin™ Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 2, 2014
First Posted Date  ICMJE May 6, 2014
Last Update Posted Date December 4, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02131194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Post-Vitrectomy Lenstatin™ Study
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cataract, Nuclear Progressive
Intervention  ICMJE
  • Dietary Supplement: Lenstatin
    Dietary Supplement Lenstatin
  • Drug: Placebo
    Placebo sugar pill manufactured to mimic Lenstatin
Study Arms  ICMJE
  • Experimental: Lenstatin
    Lenstatin (2) capsules orally per day for (6) months
    Intervention: Dietary Supplement: Lenstatin
  • Placebo Comparator: Sugar Pill
    Placebo manufactured to mimic Lenstatin (2) capsules orally per day for (6) months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02131194
Other Study ID Numbers  ICMJE 1-tunis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lenstatin LLC
Study Sponsor  ICMJE Lenstatin LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott W Tunis, MD FACS Lenstatin LLC
PRS Account Lenstatin LLC
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP