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Vascular Changes Associated With Endophthalmitis.

Vascular Changes Associated With Endophthalmitis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07175311
Enrollment
71
Registered
2025-09-16
Start date
2024-11-01
Completion date
2026-03-01
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis

Keywords

Postoperative endophthalmitis, Multimodal imaging

Brief summary

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_TESTMultimodal 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.

Sponsors

Asociación para Evitar la Ceguera en México
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Best-Corrected Visual Acuity (BCVA)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

MeasureTime frameDescription
Fluorescein AngiographyThe 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.
Fundus PhotographyThe 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.

Countries

Mexico

Contacts

Primary ContactRaúl Velez Montoya, MD
rvelezmx@yahoo.com(52) 55 5436 7335
Backup ContactBenjamín Aboytes Ríos, MD
benaborivers@gmail.com4772329592

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026