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
|Condition or disease||Intervention/treatment||Phase|
|Cataract, Nuclear Progressive||Dietary Supplement: Lenstatin Drug: Placebo||Not Applicable|
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.
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.
Participants will be randomized to treatment with Lenstatin or Placebo for (6) months following pars plana vitrectomy.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Placebo sugar pill manufactured to mimic Lenstatin
- 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.
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
|United States, North Carolina|
|Scott W. Tunis MD FACS|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Scott W Tunis, MD FACS||Lenstatin LLC|