NCT03497481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 22, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

April 6, 2018

Last Update Submit

October 24, 2022

Conditions

Keywords

eye's anterior chamber fluidcerebrospinal fluidinflammatory pathology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Neopterin concentration comparison between study values and reference value.

    3 month

  • False positives identification and elimination.

    3 month

Study Arms (1)

Neopterin Dosage

Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

Biological: Samples

Interventions

SamplesBIOLOGICAL

Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis

Neopterin Dosage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient eligible for non infectious and non inflammatory eye surgery

You may qualify if:

  • 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
  • Age \< 18 years-old

You may not qualify if:

  • Subjects who exercised his right of withdrawal
  • Study suspended on principal investigator, sponsor or health authorities' demand.
  • Deceased subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, Var, 83200, France

Location

Related 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;61(1):e20-e21. doi: 10.1515/cclm-2022-0691. Print 2023 Jan 27. No abstract available.

Biospecimen

Retention: SAMPLES WITHOUT DNA

eye's anterior chamber fluid

MeSH Terms

Conditions

Cataract

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Chaker Nefzaoui, doctor

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    PRINCIPAL INVESTIGATOR
  • Anélia Benarrosh, doctor

    Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 13, 2018

Study Start

June 22, 2018

Primary Completion

January 25, 2019

Study Completion

January 25, 2019

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

no plan

Locations