Safety And Effectiveness Of Apple Epithelial Stem Cells Extract Eye-drops In Recovering Corneal Epithelial Healing After Excimer Laser Photorefractive Keratectomy In Myopic Patients

Abstract

Purpose: : To asses safety and efficacy of an innovative formulation of eye-drops made of vegetal stem cells extracted from apples of the Uttwiler Spätlauber variety as therapy of corneal re-epithelization after excimer laser photorefractive keratectomy (PRK) in subjects with myopia ranged from - 2,5 D to - 4.5 D, with a best corrected visual acuity (BCVA) of 0.2 logMar ± sd 0.1.

Methods: : 45 subjects (90 eyes), with mean age of 32 ± sd 2 years, after excimer laser photorefractive keratectomy bilateraly were enrolled in this prospective randomized multicenter study. All subjects were treated with apple stem cells extract eye-drops in the study eye, while the fellow eye was considered as control. Patients enrolled were randomized in 2 groups: all 45 study eye were topically treated using the innovative pharmaceutical eye-drops respectively concentrated at 1% for group 1 and at 0.1% for group 2. The treatment implied 2 drops in the study eye 3 times a day for a week.

Results: : Results underwent a statistical analysis applying Anova test. The maximum stem cells extract concentration in eye-drops was of 1% because a greater concentration caused in vitro apoptosis of epithelial corneal cells. Eyes treated with a 1% apple stem cells eye-drops showed a re-epithelization in 75 ± sd 3.5 hours. We noticed a faster re-epithelization in the study eyes included in group 2, where a complete corneal re-epithelization was achieved in 18 hours (p<0.01). Furthermore, the corneal re-epithelization achieved after treatment well correlate to the BCVA, which appears stable from 24 hours after surgery. No side effects were noticed, as well as toxic effects. The vegetal stem cells eye-drops also demonstrated being a pain relief compound.

Conclusions: : Corneal wounds that occurs after PRK surgery can benefit from treatment with apple stem cells extract eye-drops. In our centre we are conducting further studies to test the therapeutical indication of this pharmaceutical compound in the prevention and the treatment of other corneal epithelial disease, both congenital, hereditary and acquired, as congenital hereditary epithelial corneal dystrophy and dry eye syndrome.

Keywords: cornea: epithelium • refractive surgery: PRK • regeneration