Glaucoma Clinical Trial
Official title:
Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma
Verified date | January 2024 |
Source | ASST Santi Paolo e Carlo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | November 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ASST Santi Paolo e Carlo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Electrofunctional evaluation | 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. | 3 months | |
Secondary | VF and SD-OCT | 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. | 3 months |
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