CHA: Neopterin Dosage in the Eye

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)
Overall Status
Completed
CT.gov ID
NCT03497481
Collaborator
Hospices Civils de Lyon (Other)
20
Enrollment
1
Location
7.1
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Samples

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.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.
Actual Study Start Date :
Jun 22, 2018
Actual Primary Completion Date :
Jan 25, 2019
Actual Study Completion Date :
Jan 25, 2019

Arms and Interventions

ArmIntervention/Treatment
Neopterin Dosage

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

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

Outcome Measures

Primary Outcome Measures

  1. Detection and dosage of neopterin in the eye [3 month]

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

Secondary Outcome Measures

  1. Neopterin concentration comparison between study values and reference value. [3 month]

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

  2. False positives identification and elimination. [3 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • Subjects who exercised his right of withdrawal

  • Study suspended on principal investigator, sponsor or health authorities' demand.

  • Deceased subjects

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Centre Hospitalier Intercommunal Toulon La Seyne sur MerToulonVarFrance83200

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Chaker Nefzaoui, doctor, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
  • Study Chair: Anélia Benarrosh, doctor, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT03497481
Other Study ID Numbers:
  • 2017-CHITS-02
  • 2017-A00183-47
First Posted:
Apr 13, 2018
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021