Vascular Changes Associated With Endophthalmitis.
ConditionEndophthalmitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAsociación para Evitar la Ceguera en México
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Multimodal imaging findings
Diagnostic testFundus 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Best-Corrected Visual Acuity (BCVA)
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.
Time frame
The assessment will be performed at each visit (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).Secondary outcomes
1
Fluorescein Angiography
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.
Time frame
The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).2
Fundus Photography
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.
Time frame
The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).Sponsors and contacts
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Source ClinicalTrials.gov