Glaucoma
Conditions
Brief summary
Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.
Detailed description
Prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution Kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression. Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms: 1. Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day) 2. Control group (CG): 10 patients will be evaluated as control Once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. The following examinations will be done in the following sequence: * Visual acuity * Slit lamp evaluation * PERG * PEV pattern * Tonometry * Visual field * Optical Coherence Tomography * Dilated Fundus examination
Interventions
OTHERFood for Special Medical Purposes: Kron®
Citicoline 40mg/ml + Nicotinamide 15 mg/ml oral solution
Sponsors
ASST Santi Paolo e Carlo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression * controlled intraocular pressure * at least 3 previous visual field examinations.
Exclusion criteria
* angle closure glaucoma and secondary open angle glaucoma * refractive error outside +2D and -6D * ophthalmic surgery 6 months before the recruitment * presence of cataract or other conditions that could affect results of perimetry or electroretinography * treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months * presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrofunctional evaluation | 3 months | Short term improvement in inner retinal function and bioelectrical activity of the visual cortex evaluated by means of PERG (P50 and N95 peaks) and PEV (P100 implicit time and N75-P100 amplitude) pattern. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VF and SD-OCT | 3 months | Visual field examination will be performed at the beginning and at the end of trial. Standard pattern short-term improvement in visual function in treated patients evaluated by means of VF. Retinal nerve fiber layer thickness, ganglion cell complex thickness and minimum rim width will be evaluated at the baseline and at the end of the study. |
Countries
Italy
Outcome results
None listed