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CompletedNCT03497481CHAUpdated Oct 26, 2022

Neopterin Dosage in the Eye

An observational study in Cataract, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.

Read the detailed description

The study will be explained to subjects who are about to undergo ophthalmologic surgery. They will sign an informed consent and be included in the study. Urine sample will be collected specifically for the study. Eye's anterior chamber fluid will also be collected during the surgery as it is the usual practice (the sample is used for the neopterin dosage instead of being thrown away).

These samples will be centrifuged, frozen in a -80° C freezer. At the end of the study, all the samples will be sent to the central Lab for the neopterin dosage analysis. Results will be communicated to the principal investigator afterward.

02

Conditions studied

  • Cataract

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Keywords

  • eye's anterior chamber fluid
  • cerebrospinal fluid
  • inflammatory pathology
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient eligible for non infectious and non inflammatory eye surgery

Inclusion criteria

  • Age ≥ 18 years-old
  • Non inflammatory or non infectious ophthalmic pathology requiring puncture of eye's anterior chamber fluid.
  • Minimum of 200 microliter sample
  • Immunocompetent subjects
  • Signed and dated informed consent
  • Samples management in accordance with the pre-analytical conditions specified in the protocol

Non-inclusion criteria:

  • Age \< 18 years-old
  • Subjects treated with intraocular corticoids, antibiotics or anti-inflammatory, locally or in systemic injection, prior to inclusion.

Exclusion criteria

Exclusion Criteria:

  • Subjects who exercised his right of withdrawal
  • Study suspended on principal investigator, sponsor or health authorities' demand.
  • Deceased subjects
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Neopterin Dosage

    Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

    Biological: Samples

Interventions

  • BiologicalSamples

    Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

05

What researchers measure

Primary outcomes

  1. Detection and dosage of neopterin in the eye

    HCL will detect and dose the neopterin in the eye's anterior chamber fluid

    Time frame: 3 month

Secondary outcomes

  1. Neopterin concentration comparison between study values and reference value.

    The reference values are standards established by the Neurobiology Lab from Lyon CHU which is the central lab that will performed the neopterin dosages.

    Time frame: 3 month

  2. False positives identification and elimination.

    False positives will be determined by calibration of creatinine dosage in eye and urine samples.

    Time frame: 3 month

06

Study locations

1 site
  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
    Toulon, Var 83200, France
07

References and documents

Publications

  • Kuvbachieva-Benarrosh A, Nefzaoui C, Quadrio I, Remignon CH, Jullian E, Perret-Liaudet A. Neopterin level can be measured by intraocular liquid biopsy. Clin Chem Lab Med. 2022 Oct 14;61(1):e20-e21. doi: 10.1515/cclm-2022-0691. Print 2023 Jan 27. No abstract available. PubMed 36227583 ↗

Individual participant data

Plan to share: No — no plan

08

Registry details

Key details

Study ID
NCT03497481
Lead sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
Jun 22, 2018
Primary completion
Jan 25, 2019
Completion
Jan 25, 2019
Last update
Oct 26, 2022

Study contacts

Chaker Nefzaoui, doctor
principal investigator · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Anélia Benarrosh, doctor
study chair · Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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