Neopterin Dosage in the Eye (CHA)

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Var
    • Toulon, Var, France, 83200
      • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient eligible for non infectious and non inflammatory eye surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection and dosage of neopterin in the eye	HCL will detect and dose the neopterin in the eye's anterior chamber fluid	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neopterin concentration comparison between study values and reference value.	The reference values are standards established by the Neurobiology Lab from Lyon CHU which is the central lab that will performed the neopterin dosages.	3 month
False positives identification and elimination.	False positives will be determined by calibration of creatinine dosage in eye and urine samples.	3 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cerebrospinal fluid; eye's anterior chamber fluid; inflammatory pathology
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2017-CHITS-02; 2017-A00183-47 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No