Effect of Oral Citicoline, Vitamins A, B, C and E, and Blackcurrant in Primary Open-Angle Glaucoma With OCT and Angiography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Evaluation of Ganglionar cells complex (GCC)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Evaluation of Retinal nerve fiber layer (RNFL)(From enrollment to the end of treatment at 1 year)
Investigators
Luca D'Andrea
Prinicipal investigator
University of Naples