Citicoline in Non-Arteritic Ischemic Optic Neuropathy

Not Applicable

Completed

Brief Summary: The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).

Detailed Description: The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar controls

Twenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
NAION patients OS-Citicoline treated	Citicoline	In a group of patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Acuity at 9 Month	9 months vs baseline	Increase of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Retinal Ganglion Cells Function at 9 Month	9 months vs Baseline	Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt)
Change From Baseline in Optic Nerve Function at 9 Months	9 months vs baseline	Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds
Change From Baseline in Optic Nerve Morphology at 9 Months	9 months vs baseline	Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron
Change From Baseline in Visual Field Defects at 9 Months	9 months vs baseline	improvement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB).