Multicenter, Prospective, Randomized, Single Blind, Cross-Over Study on the Effect of a Fixed Combination of Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram (PERG) in Patients With Open Angle Glaucoma on Well Controlled Intraocular Pressure

Frontiers in Medicine

article

Gemma Caterina Maria Rossi¹  Teresa Rolle²  Annalisa De Silvestri³  Dario Sisto⁴  Alberto Mavilio⁵  Alessandra Venera Mirabile¹  Alessia Paviglianiti¹  Beatrice Strano¹  Erica Picasso¹  Gian Maria Pasinetti⁶  Giovanni Milano¹  Giulio Ruberto¹ 

[1] Department of Surgical Sciences, University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo;Department of Surgical Sciences, School of Medicine, University of Turin;Clinical Epidemiology and Biometric Unit, Scientific Direction, Fondazione IRCCS Policlinico S. Matteo;Department of Neuroscience, Eye Clinic, Aldo Moro University of Bari;ASL of Brindisi;Eye Unit, Istituto Beato Palazzolo

关键词: glaucoma;    citicoline;    homotaurine;    pattern electroretinogram (PERG);    neuroprotection;    quality of life;    visual field;    Retimax;   

DOI  :  10.3389/fmed.2022.882335

学科分类：社会科学、人文和艺术（综合）

来源: Frontiers

【 摘 要 】

Purpose To evaluate the potential beneficial and synergistic effects of oral intake of a fixed combination of citicoline 500 mg plus homotaurine 50 mg (CIT/HOMO) on retinal ganglion cell (RGC) function in subjects with glaucoma using pattern electroretinogram (PERG) and to investigate the effects on visual field and quality of life. Methods Consecutive patients with primary open-angle glaucoma with controlled IOP (<18 mmHg) receiving beta-blockers and prostaglandin analogs alone or as combination therapy (fixed or un-fixed); with stable disease (progression no more than −1 dB/year at the visual field MD); and an early to moderate visual field defect (MD < −12 dB) were randomized to: arm A. topical therapy + CIT/HOMO for 4 months, 2 months of wash out, 4 months of topical therapy alone; arm B. topical therapy alone for 4 months, topical therapy + CIT/HOMO for 4 months, 2 months of wash out. All patients underwent 4 visits: complete ocular examination, visual field, PERG and quality of life assessment (NEI-VFQ25) were performed at each visit. Results Fifty-seven patients completed the study: 26 in group A and 31 in group B. At the end of the intake period, PERG's P50 and N95 waves recorded a greater amplitude. The increase was statistically significant in the inferior and superior P50 waves amplitude: 0.47 μV (95%CI, 0.02–0.93; p = 0.04) and 0.65 μV (95% CI, 0.16–1.13; p = 0.009), respectively, and in the inferior N95 wave amplitude 0.63 μV (95% CI, 0.22–1.04; p = 0.002). A significantly shorter peak time of 3.3 μV (95% CI, −6.01– −0.54; p = 0.01) was observed for the superior P50 wave only. Conclusions Daily oral intake of the fixed combination CIT/HOMO for 4 months improved the function of inner retinal cells recorded by PERG in the inferior and in the superior quadrants, independently from IOP reduction. This interesting association could represent a valid option for practicing neuromodulation in patients with glaucoma to prevent disease progression.

【 授权许可】

CC BY