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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03046693 |
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Date of registration:
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05/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
NAION |
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Scientific title:
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Citicoline Effect on Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) : Pattern Electroretinography Study |
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Date of first enrolment:
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January 16, 2017 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03046693 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Valen Chia, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indonesia University |
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Key inclusion & exclusion criteria
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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 to participate in the study by signing
the informed consent.
5. On bilateral NAION, examination of research done on one eye at a nearby onset of 6
weeks
Exclusion Criteria:
1. Haziness of refractive media, such as corneal opacities and opacities in the lens of
moderate to severe (color and turbidity of the lens, the cortex and the posterior
capsule with degrees LOCs III> 3).
2. Abnormalities in the macula and the optic disc due to causes other than NAION.
3. Patients with a history of glaucoma.
4. Patients with intraocular inflammation such as anterior and posterior uveitis.
5. Taking antioxidant supplements or other neuroprotective agents in the last 2 weeks
before randomization.
6. Edema of optic nerve head condition detected clinically or by OCT.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-arteritic Anterior Ischemic Optic Neuropathy
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Intervention(s)
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Drug: Group B placebo oral tablet
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Drug: Group A Citicoline 1000 mg oral tablet
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Primary Outcome(s)
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N95 wave amplitude
[Time Frame: 60 days]
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P50 wave amplitude
[Time Frame: 60 days]
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Secondary Outcome(s)
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thickness of the retinal ganglion cells
[Time Frame: 60 days]
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Visual field defect
[Time Frame: 60 days]
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Secondary ID(s)
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16-11-501
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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