Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months

February 12, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42000
        • Recruiting
        • Chu Saint Etienne
        • Contact:
        • Principal Investigator:
          • Thibaud GARCIN, MD PhD
        • Sub-Investigator:
          • Henri PITEAU, resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis

Description

Inclusion Criteria:

  • Patient who had endophtalmitis following an OZURDEX implant injection within 2 months

Exclusion Criteria:

  • Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OZURDEX patients
Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
Other: Visual acuity analysis
Collection of information on visual acuity from the medical file concerning the surgery
Other: Intraocular pressure analysis
Collection of information on intraocular pressure from the medical file concerning the surgery
Other: Analysis of optical coherence tomography (OCT) images
Collection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery
Other: Analysis of retinograms
Collection and analysis of retinography images of the medical file concerning the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 2018 to 2023
Evolution of visual acuity from the first to the last patient includes
2018 to 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP measured in mmHg by tonometer and confirmed with Goldman Applanation
Time Frame: 2018 to 2023
Changes intra ocular pressure.
2018 to 2023
Tomography
Time Frame: 2018 to 2023
Changes in the outer retina on optical coherence tomography
2018 to 2023
Resumption of intravitreal therapy
Time Frame: 2018 to 2023
Number of new intravitreal injections necessary to control the princeps pathology (AMD/OMD...) during the follow-up of the study ; i.e. relapse of activity of the princeps pathology
2018 to 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thibaud GARCIN, MD PhD, Chu Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN852023/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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