Citicoline & Antioxidants in Glaucoma

Glaucoma, Open-Angle Clinical Trial

Official title:

Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06355765
• Other study ID #: CITIZ_001
• Status: Completed
• Start date: January 10, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: April 2024
• Source: University of Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Dietary Supplement:
• Citicoline blackcurrant supplement
Citicoline, Vitamins A, B, C and E, and Blackcurrant

Locations

Country	Name	City	State
Italy	University of Naples Federico II	NAples

Sponsors (1)

Lead Sponsor	Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of Retinal nerve fiber layer (RNFL)	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)	From enrollment to the end of treatment at 1 year