Neopterin Dosage in the Eye

Completed

• Conditions: Cataract
• Interventions: Biological: Samples

• Registration Number: NCT03497481
• Lead Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2018-06-22
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neopterin Dosage	Samples	Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer; 🇫🇷 Toulon, Var, France