The Post-Vitrectomy Lenstatin™ Study

Cataract, Nuclear Progressive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131194
• Other study ID #: 1-tunis
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: December 3, 2015
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Lenstatin LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract
• Cataract, Nuclear Progressive

Intervention

Dietary Supplement:
• Lenstatin
Dietary Supplement Lenstatin

Drug:
• Placebo
Placebo sugar pill manufactured to mimic Lenstatin

Locations

Country	Name	City	State
United States	Scott W. Tunis MD FACS	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Lenstatin LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No