Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
Condition: Glaucoma; Optic Neuropathy, Ischemic; Visual Pathway Disorder; Optic Nerve; Neural Conduction
MeSH terms: Optic Nerve Diseases; Optic Neuropathy, Ischemic; Glaucoma
Study type: Interventional
Phase: Phase 4

Summary: 
      In the management of glaucoma, as for as in other optic nerve diseases, an important goal of
      ophthalmologists is represented by the possibility of influencing visual function.

      In this regard, Parisi et al [Ophthalmology 1999; 106:1126-1134.] suggested the intramuscular
      treatment with Cytidine-5-diphosphocholine (CDP-Choline or citicoline) to improve
      glaucomatous visual defects. In particular, recent studies reported the effects of citicoline
      on glaucomatous retinal and postretinal visual structures evaluated by electrophysiological
      examinations (PERG and VEP). It was observed that a 2-month period of treatment with
      citicoline may induce improvement in both ganglion cell function (PERGs with increase in
      amplitudes and shortening in times-to-peak) and in neural conduction along postretinal visual
      pathways (VEPs with increase in amplitudes and shortening in times-to-peak). The effects of
      citicoline on glaucomatous retinal and postretinal structures were not present 8 months after
      the end of treatment. However, performing several 2-month period of treatment with citicoline
      during a total period of 8 years, it was found a additional improvement of the glaucomatous
      retinal and postretinal impairment [Parisi V. Doc Ophthalmol. 2005 Jan;110:91-102). In this
      work, the investigators aimed to assess whether there similar visual function outcomes can be
      reached by the oral treatment with citicoline in patients affected by glaucomatous optic
      nerve disease as of as in other optic nerve diseases (i.e. non-arteritic ischemic optic
      neuropathy)
    

Detailed description: 
      Participants: 30 patients with open-angle glaucoma (OAG) and 15 patients (mean age
      64.6±3.3ys) with non-arteritic ischemic optic neuropathy (NION) were enrolled enrolled.

      Ten OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes)
      and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600
      mg/die per 60 days) (Cebrolux®, Tubilux, Italy).

      Methods: In T-OAG, NT-OAG and T-NION patients, Visual Evoked Potentials (VEPs)were recorded
      in response to 15' checkerboard pattern stimuli.

      VEPs were assessed 5 times during a total period of 360 days: at baseline conditions (0 day),
      after two different cycles of 60 days of treatment (days 0-60 and days 180-240), and after
      two different cycles of 120 days of wash out (days 60-180 and 240-360). In NT-AOG patients,
      VEPs were assessed at baseline conditions (0 day) and after 60, 180, 240 and 360 days.
    

Intervention name(s): Citicoline
Intervention type(s): Drug
Intervention description(s): Ten OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes) and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600 mg/die per 60 days)
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma; Optic Neuropathy, Ischemic; Visual Pathways,; Optic nerve; Neural conduction