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NCT06268561 Clinical Trial

Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months

Endophthalmitis Clinical Trial

Official title:
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06268561
Other study ID # IRBN852023/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date June 2024

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Thibaud GARCIN, MD PhD
Phone (0)477829662
Email thibaud.garcin@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 8
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Visual acuity analysis
Collection of information on visual acuity from the medical file concerning the surgery
• Intraocular pressure analysis
Collection of information on intraocular pressure from the medical file concerning the surgery
• Analysis of optical coherence tomography (OCT) images
Collection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery
• Analysis of retinograms
Collection and analysis of retinography images of the medical file concerning the surgery

Locations
Country Name City State
France CHU Saint Etienne Saint-Étienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity Evolution of visual acuity from the first to the last patient includes 2018 to 2023
Secondary IOP measured in mmHg by tonometer and confirmed with Goldman Applanation Changes intra ocular pressure. 2018 to 2023
Secondary Tomography Changes in the outer retina on optical coherence tomography 2018 to 2023
Secondary Resumption of intravitreal therapy 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
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