NCT06268561

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 5, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

November 16, 2023

Last Update Submit

February 12, 2024

Conditions

Endophthalmitis

Keywords

OZURDEXVisual AcuityEndophtalmitis

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Evolution of visual acuity from the first to the last patient includes

    2018 to 2023

Secondary Outcomes (3)

  • IOP measured in mmHg by tonometer and confirmed with Goldman Applanation

    2018 to 2023

  • Tomography

    2018 to 2023

  • Resumption of intravitreal therapy

    2018 to 2023

Study Arms (1)

OZURDEX patients

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

Other: Visual acuity analysisOther: Intraocular pressure analysisOther: Analysis of optical coherence tomography (OCT) imagesOther: Analysis of retinograms

Interventions

Visual acuity analysisOTHER

Collection of information on visual acuity from the medical file concerning the surgery

OZURDEX patients
Intraocular pressure analysisOTHER

Collection of information on intraocular pressure from the medical file concerning the surgery

OZURDEX patients
Analysis of optical coherence tomography (OCT) imagesOTHER

Collection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery

OZURDEX patients
Analysis of retinogramsOTHER

Collection and analysis of retinography images of the medical file concerning the surgery

OZURDEX patients

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint Etienne

Saint-Etienne, 42000, France

RECRUITING

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Study Officials

  • Thibaud GARCIN, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thibaud GARCIN, MD PhD

CONTACT

(0)477829662thibaud.garcin@chu-st-etienne.fr

Henri PITEAU, resident

CONTACT

(0)477829662piteau.henri@gmail.com

Study Design

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

Study Record Dates

First Submitted

November 16, 2023

First Posted

February 20, 2024

Study Start

June 5, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)