Neopterin Dosage in the Eye

Cataract Clinical Trial

— CHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497481
• Other study ID #: 2017-CHITS-02
• Secondary ID: 2017-A00183-47
• Status: Completed
• Start date: June 22, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer	Toulon	Var

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

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. doi: 10.1515/cclm-2022-0691. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	False positives identification and elimination.	False positives will be determined by calibration of creatinine dosage in eye and urine samples.	3 month