The Post-Vitrectomy Lenstatin™ Study was a randomized, prospective, double-blind, placebo controlled human clinical trial to test the efficacy of Lenstatin, a proprietary antioxidant nutritional supplement, in inhibiting nuclear cataract progression after Pars Plana Vitrectomy surgery.
Keywords: Lenstatin™; Nuclear Cataract Progression; Pars Plana Vitrectomy
Twenty patients ages 33 – 74 scheduled to undergo Pars Plana Vitrectomy (PPV) underwent pre-enrollment random allocation in equal blocks to treatment with Lenstatin versus placebo for six months following surgery. Allocation was concealed from investigators, participants, study personnel, and data collectors. The study was carried out at a single private office location in 2014-15. Participants took Lenstatin two capsules per day versus placebo for six months following PPV. Pentacam Nuclear Staging (PNS) lens densitometry measurements were taken at baseline and at six months postoperatively. No adverse reactions were encountered. Eighteen of twenty participants completed the study.
Nuclear cataract density measurements increased in nearly all patients (19/20) at six months in both Lenstatin and placebo groups. PNS Zone 1 mean density increase was 1.25% in placebo and 1.16% in Lenstatin, Average All Zones mean density increase was 1.54% in placebo and 1.19% in Lenstatin.