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Recruiting NCT07175311

Vascular Changes Associated With Endophthalmitis.

Observational Endophthalmitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal imaging findings.
Who it may be relevant to
Registry conditions: Endophthalmitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to describe and investigate vascular changes associated with exogenous endophthalmitis, as well as to create a photo library where they are evidenced

Detailed description

The implementation of multimodal imaging studies during the diagnosis and follow-up of patients with endophthalmitis may help identify, characterize, and differentiate between changes associated with host immune response, drug toxicity, or ischemia, thereby opening the possibility of implementing early treatments that lead to a better final prognosis. It is designed as a Prospective, Longitudinal, Observational, and Descriptive study. The population will be patients of the retina and vitreous service of Asociación para Evitar la Ceguera en México, who have a complete clinical record (age, sex, pathological personal history, non-pathological personal history, heredofamilial history, ophthalmologic history, allergies, medications, ophthalmologic examination with visual acuity, intraocular pressure at each visit), signed informed consent and with a history of exogenous or endogenous endophthalmitis with clear resolution criteria and clear means one week and one month after meeting the resolution criteria to be able to perform fluorescein angiography at both visits.

Interventions

  • Diagnostic test Multimodal imaging findings
    Fundus photography, Optical Coherence Tomography, and Fluorescein Angiography will be performed 7 days after meeting the criteria for inactivation of endophthalmitis, as outlined in the MEX-ESG guidelines. These imaging tests will be repeated one month after meeting the inactivation criteria.

Primary outcome measures

  • Best-Corrected Visual Acuity (BCVA) [Time frame: The assessment will be performed at each visit (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).]
Secondary outcome measures (2)
  • Fluorescein Angiography [Time frame: The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).]
  • Fundus Photography [Time frame: The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).]

Eligibility criteria

Inclusion criteria

  • Patients with a history of endophthalmitis Diagnosis of Endophthalmitis
  • Clinical symptoms: Pain, decrease in visual acuity, anterior chamber cells and/or vitreous turbidity, corneal edema, conjunctival hyperemia
  • Laboratory studies: B-mode USG and or positive culture
  • Patients who meet the endophthalmitis resolution criteria of the Mexican Endophthalmitis Study Group
  • Patients with previously signed informed consent

Exclusion criteria

  • Patients who have not signed the informed consent
  • Patients under 18 years.
  • Patients with endophthalmitis who do not meet the resolution criteria of the Mexican Endophthalmitis Study Group

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Mexico · 1 center
  • Hospital Asociación Para Evitar la Ceguera en México I.A.P. — Mexico City

Identifiers

NCT: NCT07175311 · RE-24-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗