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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
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The assessment will be performed at each visit (7 days and 1 month after meeting the inactivation criteria for endophthalmitis). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raúl Velez Montoya, MD | Contact | (52) 55 5436 7335 | rvelezmx@yahoo.com | |
| Benjamín Aboytes Ríos, MD | Contact | 4772329592 | benaborivers@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Raul Velez Montoya, MD | Asociación para Evitar la Ceguera en México | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Asociación Para Evitar la Ceguera en México I.A.P. | Recruiting | Mexico City | 04030 | Mexico |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2024 | Sep 9, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2024 | Sep 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D005128 | Eye Diseases |
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| The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis). |
| 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. | The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis). |