Skip to main content
OpenTrials
Completed

NCT Number: NCT07514845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest

Brest, 29200, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: BRESTE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.