Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis

Ocular Toxoplasmosis Clinical Trial

— COPILOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948750
• Other study ID #: COPILOT
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: May 31, 2014

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 31, 2014
• Est. primary completion date: May 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Immunocompromised patients

Related Conditions & MeSH terms

• Ocular Toxoplasmosis
• Toxoplasmosis

Intervention

Procedure:
• Aqueous humour sampling
Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting

Locations

Country	Name	City	State
France	Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Goldmann-Witmer coefficient and immunoblotting results	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.	Assessment of each test result at the inclusion of the patient