First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest (BRESTE)

NCT07514845 — Completed, 170 participants, University Hospital, Brest
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First-line Surgical Versus Medical Treatment: A Retrospective Study From 2014 to 2024 in Brest

RegistryNCT07514845, acronym BRESTE
StatusCompleted
Study typeObservational
Enrollment170 (Actual)
SponsorUniversity Hospital, Brest (Other)
ConditionsEndophthalmitis
InterventionsEarly pars plana vitrectomy (PPV) with intravitreal antibiotics (Procedure)
Datesstart 2025-01-01, primary completion 2025-12-31, completion 2025-12-31, first posted 2026-04-07, last updated 2026-04-21
Locations1 site in France

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-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.

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.

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+Arms and interventions

  • Early pars plana vitrectomy (PPV) with intravitreal antibiotics (Procedure): 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

+Outcome measures

Primary outcomes

  • Best-corrected visual acuity (BCVA) measured in logarithm of the minimum angle of resolution (logMAR) at 1 month [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Chu BrestBrestFrance