Glaucoma Clinical Trial
Official title:
Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600
mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram
after three months of therapy.
Secondary objectives are to assess effects on intraocular pressure (IOP) values, if any; to
record visual acuity, visual field, central corneal thickness (CCT), and Optical coherence
tomography (OCT) (ganglion cell complex - GCC) changes, if any and to follow quality of life
(QL) perception (general vision -GV and general health - GH of national eye instutute visual
functioning questionnaire 25 items - NEI VFQ25)
Monocentric, randomized, prospective, single blind, two treatment and two period crossover
study.
The investigators have proposed a cross-over trial to avoid or to detect the bias due to
intra-individual variability and because, from preliminary observation, it has been noted
that the effects of PEA on pattern-electroretinogram (PERG) are completely reversible after
withdrawal, within one month.
The investigators didn't considered a placebo treated group because the patient cannot
interfere with the pattern-electroretinogram PERG measurement that is objective and totally
patient-independent.
Study duration 12 months Enrolment period 6 months Minimum Follow-up 6 months Start: January,
2015; end January, 2016 Total sample size: 40 patients
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