Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months

Recruiting

• Conditions: Endophthalmitis
• Interventions: Other: Visual acuity analysis; Other: Intraocular pressure analysis; Other: Analysis of optical coherence tomography (OCT) images; Other: Analysis of retinograms

• Registration Number: NCT06268561
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-05
• Study First Submitted: 2023-11-16
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OZURDEX patients	Intraocular pressure analysis	Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
OZURDEX patients	Analysis of retinograms	Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
OZURDEX patients	Visual acuity analysis	Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
OZURDEX patients	Analysis of optical coherence tomography (OCT) images	Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis

Primary Outcome Measures

Name	Time	Method
Visual acuity	2018 to 2023	Evolution of visual acuity from the first to the last patient includes

Secondary Outcome Measures

Name	Time	Method
Tomography	2018 to 2023	Changes in the outer retina on optical coherence tomography
Resumption of intravitreal therapy	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
IOP measured in mmHg by tonometer and confirmed with Goldman Applanation	2018 to 2023	Changes intra ocular pressure.

Trial Locations

Locations (1)

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France