Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

Completed

• Conditions: Ocular Toxoplasmosis
• Interventions: Procedure: Aqueous humour sampling

• Registration Number: NCT03948750
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2014-05-31
• Study Completion: 2014-05-31
• Status Verified: 2019-05
• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

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

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Exclusion Criteria

• Immunocompromised patients

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Ocular Toxoplasmosis	Aqueous humour sampling	-
Patients without Ocular Toxoplasmosis	Aqueous humour sampling	-

Primary Outcome Measures

Name	Time	Method
Comparison of Goldmann-Witmer coefficient and immunoblotting results	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.

Trial Locations

Locations (1)

Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL); 🇫🇷 Lyon, France