The Post-Vitrectomy Lenstatin™ Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract, Nuclear Progressive
• Intervention / Treatment: Dietary supplement: Lenstatin; Drug: Placebo

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: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Scott W. Tunis MD FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pentacam Nuclear Density Measurements	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.	(6) months

Collaborators and Investigators

• Sponsor: Lenstatin LLC
• Investigators: Principal Investigator: Scott W Tunis, MD FACS, Lenstatin LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: May 2, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (ESTIMATE): May 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cataract; Nutritional Supplement
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1-tunis