- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514845
First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest (BRESTE) (BRESTE)
First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest
The goal of this observational cohort study is to evaluate the impact of early pars plana vitrectomy (PPV) on visual outcomes in adults diagnosed with acute endophthalmitis. It also aims to identify prognostic factors associated with visual recovery.
The main questions it aims to answer are:
Does early PPV (within 48 hours of diagnosis) improve visual acuity at 1 month compared with initial medical management? Which baseline clinical and microbiological factors are associated with worse visual outcomes?
Participants with acute endophthalmitis receiving standard care in routine clinical practice will be included. Patients undergoing early PPV will be compared with those receiving initial medical treatment alone or with delayed PPV to assess differences in visual outcomes.
Clinical data, including visual acuity, treatment characteristics, microbiological findings, and complications, will be collected retrospectively from medical records, with follow-up outcomes assessed at 1, 3, and 6 months.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brest, France, 29200
- CHU Brest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Clinically diagnosed acute endophthalmitis
- Onset within 6 weeks following intraocular procedure (cataract surgery, intravitreal injection, anterior or posterior segment surgery)
- Endophthalmitis associated with trauma, infectious keratitis, bleb-related infection, or endogenous infection
- Availability of clinical data including visual acuity and treatment information
Exclusion Criteria:
- Age < 18 years
- Chronic endophthalmitis (> 6 weeks after procedure)
- Non-infectious conditions (e.g., toxic anterior segment syndrome, postoperative inflammatory reaction)
- Documented refusal or opposition to use of clinical data
- Insufficient clinical data, particularly missing visual acuity or treatment informationcuity or treatment information
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) at 1 month
Time Frame: 1 month after diagnosis of acute endophthalmitis
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Best-corrected visual acuity (BCVA), measured using the logarithm of the minimum angle of resolution (logMAR) scale, assessed at 1 month after diagnosis of acute endophthalmitis.
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1 month after diagnosis of acute endophthalmitis
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Eye Diseases
- Eye Infections
- Endophthalmitis
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Sensitivity and Specificity
- Predictive Value of Tests
Other Study ID Numbers
- 29BRC25.0153 - BRESTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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