Clinical Trials Directory

Trials / Completed

CompletedNCT07514845

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
170 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEarly 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

Timeline

Start date
2025-01-01
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2026-04-07
Last updated
2026-04-07

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07514845. Inclusion in this directory is not an endorsement.