Clinical Trial: Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) : Pattern Electroretinography Study

Brief Summary:

Clinical trial.gov

Brief summary :

Non-arteritic anterior ischemic optic neuropathy (NAION) is an optic neuropathy due to acute or subacute ischemic event of anterior optic nerve axons retrolaminar part that was vascularized by posterior ciliary brevis artery. The incidence of ischemia will be followed by axonal edema and causing compartment syndrome and heighten the incidence of ischemic.

In NAION, the main pathology occurs at the level of the optical nerve, the axons of retinal ganglion cells. Initial damage is on the optic disc ischemia resulting hypoxic injury of axons and manifest as disc edema. Axonal edema cause disturbances of retrograde axonal transport of neurotrophic factors, especially brain derived neurotrophic factor, to the retinal ganglion cells. This will trigger a secondary toxicity and apoptosis. In addition, the presence of oxidative stress, calcium influx and mitochondrial damage will also triggers apoptosis. After the apoptosis of retinal ganglion cells, there was a thinning of the retinal nerve fiber layer (RNFL) through Wallerian degeneration. Thinning of the RNFL will manifest as visual field defects and the decline in visual acuity in patients with chronic phase NAION.

Though NAION include disease entity that has long existed, but until now, there has been no evidence-based study on medical or surgical procedures that is effective enough to overcome NAION. The main treatment is to manage the risk factor such as hypertension, dyslipidemia, diabetes mellitus, hypercoagulable state. In general, if the patient is in the acute phase (edema of optic nerve head), methylprednisolone administration may be considered, but if the patient is already on chronic phase (atrophy disc) which generally occurs 6-11 we

Detailed Summary:

Research design This study is a double blind randomized clinical trial to determine differences in wave amplitude P50 and N95 on pattern ERG examination, visual field defects (LP) with Humphrey HFA (Humphrey Field Analyzer) II-i 750, 24-2 threshold and ganglion cell thickness with OCT CirrusTM between the administration of citicoline and placebo in patients with non-arteritic anterior ischemic optic neuropathy (NAION) chronic phase. Masking applied to patients and researchers.

Research Time and Place This research was conducted at the Eye Clinic Division of Neuro-Ophthalmology Faculty of medicine Universitas Indonesia- RSCM (Cipto Mangunkusumo Hospital) Kirana (single centre), Jakarta, Indonesia in November 2016-June 2017.

Population and Sample Research The target population of this study is that patients with chronic phase NAION. Samples were selected with consecutive sampling method, ie all NAION patients with chronic phase who came to the Faculty of medicine Universitas Indonesia-RSCM Kirana Neuro-ophthalmology division fulfilled the inclusion criteria included in the study and randomize by researchers. If the patient NAION was in acute phase, in the further visit became chronic phase and met the inclusion criteria, then the patient can be a sample.

Inclusion criteria

  1. Patients aged 20-65 years.
  2. NAION patients who have been diagnosed clinically by a minimum of 1 consultant Division NO with onset ≥6 weeks.
  3. Best corrected visual acuity ≥ 1/60 Snellen
  4. Patients have to get an explanation about the purpose of the research and all the procedures that will be undertaken and willing t
    Sponsor: Valen Chia

    Current Primary Outcome:

    • P50 wave amplitude [ Time Frame: 60 days ]
      amplitude measured from the valley of N35 to the peak of P50 with pattern electroretinography
    • N95 wave amplitude [ Time Frame: 60 days ]
      amplitude measured from peak of P50 to valley of N95 with pattern electroretinography


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • thickness of the retinal ganglion cells [ Time Frame: 60 days ]
      anatomical cross-sectional examination of retinal ganglion cells using optical coherence tomography (OCT) CirrusTM HD-OCT 5000. The mode is panomap ganglion cell analysis: Macular Cube 512x128 and 200x200 cube Optic disc. Examination is repeated with minimal attention to signal strength is ≥ 5.
    • Visual field defect [ Time Frame: 60 days ]

      visual field test results using Humphrey HFA II-i 750, 24-2 threshold. Examination is repeated by taking into account the confidence index that meets the three criteria below:

      1. Fixation losses ≤ 20%
      2. False positive ≤ 15%
      3. False negative ≤ 20-30%

      The parameters assessed are:

      1. The mean deviation (MD): the result of the average sensitivity of the retina of patients compared with the normal population. This figure is obtained from the total deviation.
      2. Pattern standard deviation (PSD): the result of the average sensitivity of the retina of patients who have adapted and showed a localized area index. This figure is obtained from the pattern deviation.


    Original Secondary Outcome: Same as current

    Information By: Indonesia University

    Dates:
    Date Received: February 5, 2017
    Date Started: January 16, 2017
    Date Completion: May 2017
    Last Updated: February 8, 2017
    Last Verified: February 2017