Citicoline Concentration in Human Vitreous

Study Overview
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Brief Summary
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Elegible patients were included in the study and underwent treatment with a solution of citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride prior to surgery. The vitreous samples were taken at the beginning of the surgery and analyzed for qualitative/quantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography.

Detailed Description
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At the visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and fundus dilated indirect ophthalmoscopy. Additionally, all patients had central retinal thickness measurements with spectral-domain optical coherence tomography associated with central corneal thickness (CCT) and corneal endothelial cells density (ECD) evaluations. Patients started the treatment with 1 drop of a solution of citicoline 1% eye-drops, 0.2% hyaluronic acid and 0.01% benzalkonium chloride for 3 times/day over a total time of 14 days before surgery and 1 drop 2 hours prior to the surgery. Five patients served as controls and received a vehicle solution without citicoline. The primary aim of the study was to evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration by means of high performance liquid chromatography. Secondary aims were the comparison of citicoline and its metabolites concentration in the vitreous of treated phakic and pseudophakic eyes and the correlations with age and ocular biometric parameters including CCT and ECD.

Official Title
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Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration: a Cross-sectional Study

Conditions
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Neurodegenerative Diseases

Intervention / Treatment
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* Drug: Citicoline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years ability to understand and sign the written informed consent diagnosis of epiretinal membrane (ERM) with surgical indication for pars-plana vitrectomy Exclusion Criteria: laser treatments and ocular surgery in the past 6 months hypersensitivity to the active ingredients used in the study other systemic or ocular diseases different from ERM that could affect the outcome of the study aphakia or previous complicated cataract surgery intraocular lens (IOL) in the anterior chamber treatment with systemic citicoline or other potential neuroprotective agents in the past 6 months pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citicoline eyes<br>Patients had to administer 3 drops/day of an ophthalmic solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride for 14 days before surgery and 2 hours prior to surgery. | Drug: Citicoline<br>* After treatment with a solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride patients underwent a 23G standard 3-port pars plana vitrectomy. The vitreous sample was taken at the beginning of the surgery and then analyzed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citicoline and metabolites concentration in human vitreous | Evaluate the presence and concentration of citicoline and its metabolites (choline, cytidine and uridine) in the vitreous body in vivo in human eyes after topical eye-drops administration. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citicoline and metabolites concentration in phakic and pseudophakic eyes | Comparison of citicoline and its metabolites concentration in the vitreous of phakic and pseudophakic eyes and correlations with age, central corneal thickness and corneal endothelial cells density. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ophthalmic solution, glaucoma, retinal ganglion cells, neuroprotective effect