Clinical trial NCT02131194: The Post-Vitrectomy Lenstatin™ Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract, Nuclear Progressive
Keywords: Cataract
Nutritional Supplement
Lead sponsor: Lenstatin LLC
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Pentacam Nuclear Density Measurements
timeFrame: (6) months
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Scott W. Tunis MD FACS
state: North Carolina
Study officials:
affiliation: Lenstatin LLC
name: Scott W Tunis, MD FACS
role: PRINCIPAL_INVESTIGATOR
References: