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Completed

NCT Number: NCT04003090

Citicoline Concentration in Human Vitreous

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione G.B. Bietti- IRCCS

Roma, 00198, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citicoline

Drug

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.

Primary outcomes

  1. Citicoline and metabolites concentration in human vitreous

    Time frame: 14 days

    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.

Secondary outcomes

  1. Citicoline and metabolites concentration in phakic and pseudophakic eyes

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Istituto di Ricerca Neuroftalmologia S.r.l.

Network

Collaborators

  • Fondazione G.B. Bietti, IRCCS

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2019
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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