EndophthalmitisBRESTENCT07514845
First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest (BRESTE)
An observational study of Endophthalmitis, run by University Hospital, Brest at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Early pars plana vitrectomy (PPV) with intravitreal antibiotics
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort includes adult patients diagnosed with acute endophthalmitis and managed at two referral centers (University Hospital of Brest and Pasteur Clinic, France) between January 2014 and December 2024. Patients were identified using International Classification of Diseases, 10th Revision (ICD-10) codes and included a broad spectrum of etiologies (postoperative, post-intravitreal injection, traumatic, bleb-related, and endogenous endophthalmitis), reflecting real-world clinical practice.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Conditions
- Endophthalmitis
- Being tested
- Early pars plana vitrectomy (PPV) with intravitreal antibiotics
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early pars plana vitrectomy (PPV) with intravitreal antibioticsProcedure or surgery
Early pars plana vitrectomy (PPV) was defined as PPV performed within 48 hours of diagnosis of acute endophthalmitis, combined with intravitreal antibiotic administration (vancomycin and ceftazidime) at the end of surgery. Vitrectomy was performed using standard transscleral techniques (20-, 23-, or 25-gauge), with systematic collection of undiluted vitreous samples for microbiological analysis prior to antibiotic injection. Endoscopic assistance could be used depending on surgical conditions and operator preference.
The comparator strategy consisted of initial medical management with intravitreal antibiotic injection (vancomycin and ceftazidime), typically preceded by anterior chamber paracentesis for microbiological sampling. In this group, some patients could subsequently undergo delayed PPV (≥48 hours after diagnosis) based on clinical evolution.
All treatment decisions, including use of systemic antibiotics, corticosteroids, and surgical approach, were made at the discretion of
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) at 1 month
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.
Measured: 1 month after diagnosis of acute endophthalmitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 University Hospital, BrestThe 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514845
- Sponsor's protocol ID
- 29BRC25.0153 - BRESTE
- Acronym
- BRESTE
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest
- ClinicalTrials.gov ID
- NCT07514845
- Acronym / sponsor ID
- BRESTE / 29BRC25.0153 - BRESTE
- Conditions
- Endophthalmitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Apr 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort includes adult patients diagnosed with acute endophthalmitis and managed at two referral centers (University Hospital of Brest and Pasteur Clinic, France) between January 2014 and December 2024. Patients were identified using International Classification of Diseases, 10th Revision (ICD-10) codes and included a broad spectrum of etiologies (postoperative, post-intravitreal injection, traumatic, bleb-related, and endogenous endophthalmitis), reflecting real-world clinical practice.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Early pars plana vitrectomy (PPV) with intravitreal antibioticsEarly pars plana vitrectomy (PPV) was defined as PPV performed within 48 hours of diagnosis of acute endophthalmitis, combined with intravitreal antibiotic administration (vancomycin and ceftazidime) at the end of surgery. Vitrectomy was performed using standard transscleral techniques (20-, 23-, or 25-gauge), with systematic collection of undiluted vitreous samples for microbiological analysis prior to antibiotic injection. Endoscopic assistance could be used depending on surgical conditions and operator preference. The comparator strategy consisted of initial medical management with intravitreal antibiotic injection (vancomycin and ceftazidime), typically preceded by anterior chamber paracentesis for microbiological sampling. In this group, some patients could subsequently undergo delayed PPV (≥48 hours after diagnosis) based on clinical evolution. All treatment decisions, including use of systemic antibiotics, corticosteroids, and surgical approach, were made at the discretion of | Procedure or surgery | – |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Intracameral Levofloxacin Versus Moxifloxacin After Cataract Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University Hospital, Brest 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 21 Apr 2026.