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- Title
The effect of citicoline oral solution on quality of life in patients with glaucoma: the results of an international, multicenter, randomized, placebo-controlled cross-over trial.
- Authors
Rossetti, Luca; Goni, Francisco; Montesano, Giovanni; Stalmans, Ingeborg; Topouzis, Fotis; Romano, Dario; Galantin, Eleonora; Delgado-Gonzales, Noemi; Giammaria, Sara; Coco, Giulia; Vandewalle, Evelien; Lemmens, Sophie; Giannoulis, Dimitrios; Pappas, Theofanis; Manni, Gianluca
- Abstract
Purpose: This study aims to evaluate whether the use of citicoline oral solution could improve quality of life in patients with chronic open-angle glaucoma (OAG). Design: Randomized, double-masked, placebo-controlled, cross-over study was used. Patients were randomized to one of the two sequences: either citicoline 500 mg/day oral solution-placebo or placebo-citicoline 500 mg/day oral solution. Switch of treatments was done after 3 months; patients were then followed for other 6 months. Follow-up included 3-month, 6-month, and 9-month visits. Outcomes: The primary outcome was the mean change of "intra-patient" composite score of the Visual Function Questionnaire-25 (VFQ-25). after citicoline oral solution vs placebo at 6-month visit as compared with baseline. Methods: The trial was multicenter, conducted at 5 European Eye Clinics. OAG patients with bilateral visual field damage, a mean deviation (MD) ranging from − 5 to − 13 dB in the better eye, and controlled IOP were included. VFQ-25 and SF-36 questionnaires were administered at baseline and at 3-, 6-, and 9-month visits. A mixed effect model, with a random effect on the intercept, accounted for correlations among serial measurements on each subject. Results: The primary pre-specified outcome of the analysis reached statistical significance (p = 0.0413), showing greater improvement after citicoline oral solution. There was an increase in the composite score in both arms compared to baseline, but it was significant only for the placebo-citicoline arm (p = 0.0096, p = 0.0007, and p = 0.0006 for the three time-points compared to baseline). The effect of citicoline was stronger in patients with vision-related quality of life more affected by glaucoma at baseline. Conclusions: This is the first placebo-controlled clinical study evaluating the effect of a medical treatment aiming at improving vision-related quality of life in glaucomatous patients.
- Subjects
CYTIDINE diphosphate choline; CROSSOVER trials; QUALITY of life; OPEN-angle glaucoma; GLAUCOMA
- Publication
Graefe's Archive of Clinical & Experimental Ophthalmology, 2023, Vol 261, Issue 6, p1659
- ISSN
0721-832X
- Publication type
Article
- DOI
10.1007/s00417-022-05947-5