Neopterin Dosage in the Eye

NCT03497481 — Completed, 20 participants, Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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

Registry	NCT03497481, acronym CHA
Status	Completed
Study type	Observational
Enrollment	20 (Actual)
Sponsor	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other); collaborators: Hospices Civils de Lyon
Conditions	Cataract
Interventions	Samples (Biological)
Dates	start 2018-06-22, primary completion 2019-01-25, completion 2019-01-25, first posted 2018-04-13, last updated 2022-10-26
Locations	1 site in France

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Neopterin Dosage		Biological: Samples	Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

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

+Outcome measures

Primary outcomes

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 outcomes

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.
False positives identification and elimination. [3 month]: False positives will be determined by calibration of creatinine dosage in eye and urine samples.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon, Var	France

+Publications

Results publication: 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. PMID 36227583

+Investigators

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

My Notes

Public

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