Clinical trial NCT03497481: Neopterin Dosage in the Eye
Official title: Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: eye's anterior chamber fluid
cerebrospinal fluid
inflammatory pathology
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2018-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient eligible for non infectious and non inflammatory eye surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection and dosage of neopterin in the eye
timeFrame: 3 month
Secondary outcomes:
measure: Neopterin concentration comparison between study values and reference value.
timeFrame: 3 month
measure: False positives identification and elimination.
timeFrame: 3 month
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Chaker Nefzaoui, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Anélia Benarrosh, doctor
role: STUDY_CHAIR
References:
citation: 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.