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NCT Number: NCT07175311

Vascular Changes Associated With Endophthalmitis.

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, 04030, Mexico

Location status: Recruiting

Location contact

Benjamín Aboytes Ríos, MD

CONTACT

[email protected]

4772329592

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Multimodal imaging findings

Diagnostic Test

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 outcomes

  1. 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).

    Best-Corrected Visual Acuity (BCVA) will be assessed according to the ETDRS guidelines. The test must be performed with the patient positioned 4 meters from the backlit panel, which must be calibrated to emit 85 cd/m². This procedure will be carried out by the retina fellow assigned to the case.

Secondary outcomes

  1. 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).

    Fluorescein angiography will be performed subsequently to evaluate associated vascular changes. The patient must undergo an 8-hour fast and have pupillary dilation with TP Ofteno® (tropicamide 5% / phenylephrine 0.8%). The procedure involves preparing the patient with aseptic technique for an intravenous injection of fluorescein dye in an upper limb, followed by imaging with a fundus camera. It is not essential to use a device of a specific brand or model, as long as a system with equivalent specifications is used consistently for the same patient throughout the study. A technician or delegated personnel may perform the procedure.

  2. 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).

    Fundus imaging will be performed using the Clarus 700 Zeiss, Serial #CL700-73467, Software version 1.1.2.59261, Digital Camera Magnification 133°. Images of the posterior pole and retinal periphery will be captured, providing a comprehensive view of retinal integrity, the optic nerve, and its vasculature.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamín Aboytes Ríos, MD

CONTACT

[email protected]

4772329592

Raúl Velez Montoya, MD

CONTACT

[email protected]

(52) 55 5436 7335

Sponsors and collaborators

Lead sponsor

Asociación para Evitar la Ceguera en México

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

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.

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