Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2022-01-10
2022-12-10
Brief Summary
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Detailed Description
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METHODS: Fifteen patients with POAG (treated group) received one soluble liquid sachet daily for 20 days a month of a complementary dietary supplement containing in fixed combination citicoline, vitamins A, B, C, and E, and blackcurrant for 1 year. Fifteen age-matched subjects affected by POAG were given a placebo and served as a control group. The patients underwent best corrected visual acuity (BCVA), Goldmann applanation tonometry, microperimetry examination, OCT, and OCTA at the beginning of the study and then at 1, 6 and 12 months.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Citicoline blackcurrant
The treated group received a unique combination of oral dietary supplements, formulated in a soluble liquid sachet format for optimal absorption and convenience. This formulation included the following key components: citicoline (500 mg), vitamins A (300 μm), B group (4.415 mg), C (115 μm), and E (5 μm), and blackcurrant extract (50 mg). The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period
Citicoline blackcurrant supplement
Citicoline, Vitamins A, B, C and E, and Blackcurrant
Placebo
The treated group received a unique combination of oral placebo. The participants in the treated group were instructed to take one sachet daily for 20 days each month, followed by a 10-day pause, and this therapy cycle was repeated throughout the 12-month follow-up period
No interventions assigned to this group
Interventions
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Citicoline blackcurrant supplement
Citicoline, Vitamins A, B, C and E, and Blackcurrant
Eligibility Criteria
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Inclusion Criteria
* aged between 18 and 75 years
* Patients with controlled intraocular pressure (IOP) below 20 mmHg, who had been on the same topical hypotensive therapy for at least 3 months
* myopia less than 5 diopters (D) were considered eligible for inclusion.
Exclusion Criteria
* hyper-sensitivity to citicoline,
* a history of optic neuritis,
* previous glaucoma or retinal surgery,
* prior cataract or refractive surgery,
* macular degeneration or other retinal disorders,
* any systemic diseases that could potentially lead to neurodegeneration (e.g., multiple sclerosis, diabetes)
30 Years
90 Years
ALL
No
Sponsors
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University of Naples
OTHER
Responsible Party
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Luca D'Andrea
Prinicipal investigator
Principal Investigators
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Luca D'Andrea, MD
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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Other Identifiers
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CITIZ_001
Identifier Type: -
Identifier Source: org_study_id
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