NCT03948750

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

Study Start

First participant enrolled

January 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2014

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

4.4 years

First QC Date

May 10, 2019

Last Update Submit

May 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with Ocular Toxoplasmosis

Procedure: Aqueous humour sampling

Patients without Ocular Toxoplasmosis

Procedure: Aqueous humour sampling

Interventions

Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting

Patients with Ocular ToxoplasmosisPatients without Ocular Toxoplasmosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Immunocompromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, 69004, France

Location

MeSH Terms

Conditions

Toxoplasmosis, Ocular

Condition Hierarchy (Ancestors)

Eye Infections, ParasiticParasitic DiseasesInfectionsToxoplasmosisCoccidiosisProtozoan InfectionsEye InfectionsEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

January 1, 2010

Primary Completion

May 31, 2014

Study Completion

May 31, 2014

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations