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Completed

NCT Number: NCT03948750

Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)

Lyon, 69004, France

About this study

Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.

GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)

0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis

Exclusion criteria

  • Immunocompromised patients

Treatment and study plan

Aqueous humour sampling

Procedure

Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting

Primary outcomes

  1. Comparison of Goldmann-Witmer coefficient and immunoblotting results

    Time frame: Assessment of each test result at the inclusion of the patient

    All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients

Acronym: COPILOT

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 14, 2019
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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