Citicoline & Antioxidants in Glaucoma

NCT06355765 | Completed

• 1 other identifier: CITIZ_001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• Evaluation of Ganglionar cells complex (GCC)

  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) on GCC using optical coherence tomography (OCT)

  From enrollment to the end of treatment at 1 year

Secondary Outcomes (1)

• Evaluation of Retinal nerve fiber layer (RNFL)

  From enrollment to the end of treatment at 1 year

Study Arms (2)

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

Dietary Supplement: Citicoline blackcurrant supplement

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

Interventions

Citicoline blackcurrant supplement DIETARY_SUPPLEMENT

Citicoline, Vitamins A, B, C and E, and Blackcurrant

Citicoline blackcurrant

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Naples: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Luca D'Andrea, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 9, 2024
• Study Start: January 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: December 10, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

IT (1)