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OpenTrials
Completed

NCT Number: NCT06355765

Citicoline & Antioxidants in Glaucoma

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Citicoline blackcurrant supplement

Dietary Supplement

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

Primary outcomes

  1. Evaluation of Ganglionar cells complex (GCC)

    Time frame: 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 outcomes

  1. Evaluation of Retinal nerve fiber layer (RNFL)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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