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Completed

NCT Number: NCT03497481

Neopterin Dosage in the Eye

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

samples

Biological

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

Primary outcomes

  1. Detection and dosage of neopterin in the eye

    Time frame: 3 month

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

Secondary outcomes

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

    Time frame: 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.

    Time frame: 3 month

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.

Acronym: CHA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
Oct 26, 2022

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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