Abstract
Purpose: :
A previous study demonstrated that high oral doses of 9-cis beta carotene improve retinal functions significantly as measured by electroretinography and the perimetry in patients with a specific type of congenital stationary night blindness. The purpose of this study is to determine whether the same therapy is efficacious for treating retinitis pigmentosa patients who were genetically evaluated.
Methods: :
In a double-masked, placebo-control cross-over trial, patients with retinitis pigmentosa were given daily four commercially available 15mg capsules containing powder rich in 9-cis Beta Carotene for 90 days. The patients were tested for best corrected visual acuity and underwent electroretinography using an ISCEV compliant protocol, mesopic and scotopic Goldmann perimetry and fundus imaging.
Results: :
No complications were recorded to be associated with the treatment. Patients reported visual improvement which was confirmed by a significant improvement in retinal functions as measured by visual acuity tests, perimetry and electroretinography
Conclusions: :
The outcomes of the initial subjects suggest that 9-cis beta carotene is safe and effective in human patients with retinitis pigmentosa. The extent of visual function improvement and the optimal dose have to be further evaluated.
Clinical Trial: :
www.clinicaltrials.gov NCT00569023
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • retinal degenerations: hereditary • nutritional factors