EndophthalmitisNCT06268561
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
An observational study of Endophthalmitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Visual acuity analysis, Intraocular pressure analysis and Analysis of optical coherence tomography (OCT) images
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
Who may be able to join
- Patient who had endophtalmitis following an OZURDEX implant injection within 2 months
Who cannot join
- Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42000
Thibaud GARCIN, MD PhD, (0)477829662 ext. +33, thibaud.garcin@chu-st-etienne.fr
Thibaud GARCIN, MD PhD
About this study
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.
- Conditions
- Endophthalmitis
- Being tested
- Visual acuity analysis, Intraocular pressure analysis, Analysis of optical coherence tomography (OCT) images, Analysis of retinograms
- Keywords
- OZURDEX, Visual Acuity, Endophtalmitis
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual acuity analysisOther
Collection of information on visual acuity from the medical file concerning the surgery
Intraocular pressure analysisOther
Collection of information on intraocular pressure from the medical file concerning the surgery
Analysis of optical coherence tomography (OCT) imagesOther
Collection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery
Analysis of retinogramsOther
Collection and analysis of retinography images of the medical file concerning the surgery
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX patients | Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis Receives: Other: Visual acuity analysis; Other: Intraocular pressure analysis; Other: Analysis of optical coherence tomography (OCT) images; Other: Analysis of retinograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Evolution of visual acuity from the first to the last patient includes
Measured: 2018 to 2023
Secondary outcomes (3)
IOP measured in mmHg by tonometer and confirmed with Goldman Applanation
Changes intra ocular pressure.
Measured: 2018 to 2023
Tomography
Changes in the outer retina on optical coherence tomography
Measured: 2018 to 2023
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
Measured: 2018 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start5 Jun 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaud GARCIN, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268561
- Sponsor's protocol ID
- IRBN852023/CHUSTE
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
- ClinicalTrials.gov ID
- NCT06268561
- Acronym / sponsor ID
- IRBN852023/CHUSTE
- Conditions
- Endophthalmitis
- Keywords
- OZURDEX, Visual Acuity, Endophtalmitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX patients | – | Other: Visual acuity analysis, Other: Intraocular pressure analysis, Other: Analysis of optical coherence tomography (OCT) images, Other: Analysis of retinogramsPatients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis
Key inclusion criteria (1 listed)
- Patient who had endophtalmitis following an OZURDEX implant injection within 2 months
Key exclusion criteria (1 listed)
- Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual acuity analysisCollection of information on visual acuity from the medical file concerning the surgery | Other | OZURDEX patients |
| Intraocular pressure analysisCollection of information on intraocular pressure from the medical file concerning the surgery | Other | OZURDEX patients |
| Analysis of optical coherence tomography (OCT) imagesCollection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery | Other | OZURDEX patients |
| Analysis of retinogramsCollection and analysis of retinography images of the medical file concerning the surgery | Other | OZURDEX patients |
Primary outcome
Visual acuity
Time frame: 2018 to 2023
Evolution of visual acuity from the first to the last patient includes
3 secondary outcomes
IOP measured in mmHg by tonometer and confirmed with Goldman Applanation
Time frame: 2018 to 2023
Tomography
Time frame: 2018 to 2023
Resumption of intravitreal therapy
Time frame: 2018 to 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Endophthalmitis
Not yet recruiting
Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis
Endophthalmitis, Infectious Endophthalmitis
RecruitingObservational study
Nanopore Sequencing in Ophthalmology
Endophthalmitis
Not yet recruiting
Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
Cataract, Postoperative Endophthalmitis
RecruitingPhase 1
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
Ocular Inflammation, Crystalline Lens; Chalcosis
Not yet recruitingPhase 2/3
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery
Endophthalmitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibaud GARCIN, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endophthalmitis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibaud GARCIN, MD PhD ((0)477829662 ext. +33, thibaud.garcin@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 2018 to 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.