Citicoline & Antioxidants in Glaucoma

University of Naples

Status: Completed

Conditions: Glaucoma, Open-Angle

Treatments: Dietary Supplement: Citicoline blackcurrant supplement

Study type: Observational

Funder types: Other

Identifiers

NCT06355765

CITIZ_001

Details and patient eligibility

About

To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

Full description

AIMS: To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters.

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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of POAG
• 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

• IOP levels exceeding 21 mmHg,
• 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)

Trial design

60 participants in 2 patient groups

Citicoline blackcurrant

Description:

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

Treatment:

Dietary Supplement: Citicoline blackcurrant supplement

Placebo

Description:

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