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

NCT07514845 | Completed

• 1 other identifier: 29BRC25.0153 - BRESTE
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Endophthalmitis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after diagnosis of acute endophthalmitis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

Predictive Value of Tests

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)