Glaucoma
Conditions
Keywords
glaucoma, nutraceuticals, dha (docosahexaenoic acid), citicoline
Brief summary
Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.
Interventions
DIETARY_SUPPLEMENTCiticoline and Docosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.
DIETARY_SUPPLEMENTCiticoline
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.
DIETARY_SUPPLEMENTDocosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.
DIETARY_SUPPLEMENTVitamin C
Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
Sponsors
Institut Catala de Retina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria: * Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT. * Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph. 2. There must be at least 3 reliable visual fields prior to the start of the study. 3. Patients between 50 and 75 years old, homogeneously distributed among the groups. 4. Glaucoma with functional and structural damage. * Medium grade, Mean Deviation (MD) between -4 and -20 dB. * In at least one eye.
Exclusion criteria
1. Treatment with some other vitamin or nutraceutical preparation. 2. Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)). 3. Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.) 4. Allergic to fish protein. 5. Eye surgery in the 3 months before or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on Mean Defect (MD) | From Baseline to Month 3. | Evaluation of changes on the MD (decibels) with study treatment. |
| Effect on Visual Field Index (VFI) | From Baseline to Month 3. | Evaluation of changes on the VFI (%) with study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the changes produced in the intraocular pressure (IOP) | From Baseline to Month 3. | To compare IOP (mmHg) measurements with study treatment. |
| Evaluation of tolerance | From Month 1 to Month 3 | Describe the tolerance and the adverse events with study treatment. |
Countries
Spain
Outcome results
None listed