Study design
VF
TREATMENT SIDE EFFECTS, LENS
The trial was a randomized, double-masked, placebo-controlled, cross-over study. Patients who accepted to participate in the trial signed an informed consent form and were randomized to one of the two sequences of the cross-over design: either citicoline 50 mg/ml oral solution-placebo or placebo-citicoline 50 mg/ml oral solution. The randomization was stratified by center.The study protocol included the following visits:Baseline visit (beginning of 1st period): Patients underwent a complete ophthalmic examination, including BCVA, biomicroscopy (with a specific lens evaluation using the Lens Opacities Classification System III, LOCS III, criteria [3-month visit (end of the 16-month visit: Patients were asked again about treatment side effects, and all complains/considerations were recorded. Patients were again administered the 2 study questionnaires (SF-36 and VFQ-25). A complete ophthalmic examination and a VF test with the same strategy were performed. Patients received the assigned bottles for the third 3-month phase.9-month visit (end of the 2st period): Patients were asked again about treatment side effects and administered the two study questionnaires (VFQ-25 and SF-36). A final, complete ophthalmic examination and a VF test with the same strategy were performed.