Citicoline & Antioxidants in Glaucoma

Completed

• Conditions: Glaucoma, Open-Angle
• Interventions: Dietary Supplement: Citicoline blackcurrant supplement

• Registration Number: NCT06355765
• Lead Sponsor: University of Naples

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-09
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Citicoline blackcurrant	Citicoline blackcurrant supplement	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

Primary Outcome Measures

Name	Time	Method
Evaluation of Ganglionar cells complex (GCC)	From enrollment to the end of treatment at 1 year	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)

Secondary Outcome Measures

Name	Time	Method
Evaluation of Retinal nerve fiber layer (RNFL)	From enrollment to the end of treatment at 1 year	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 RNFL using optical coherence tomography (OCT)

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 NAples, Italy