Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04003090
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2019-06-27
Brief Title:
Citicoline Concentration in Human Vitreous
Sponsor:
Istituto di Ricerca Neuroftalmologia Srl
Organization:
Istituto di Ricerca Neuroftalmologia Srl
Study Overview
Official Title:
Evaluation of Citicoline Concentration in Human Vitreous After Topical Administration a Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Elegible patients were included in the study and underwent treatment with a solution of citicoline 1 eye-drops 02 high molecular weight hyaluronic acid and 001 benzalkonium chloride prior to surgery The vitreous samples were taken at the beginning of the surgery and analyzed for qualitativequantitative determination of vitreous concentration of citicoline and its metabolites by means of high performance liquid chromatography
Detailed Description:
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 02 hyaluronic acid and 001 benzalkonium chloride for 3 timesday 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
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 02 hyaluronic acid and 001 benzalkonium chloride for 3 timesday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None