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RecruitingNCT07175311Updated Sep 16, 2025

Vascular Changes Associated With Endophthalmitis.

An observational study in Endophthalmitis, sponsored by Asociación para Evitar la Ceguera en México. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Asociación para Evitar la Ceguera en México · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
71
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Endophthalmitis

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Keywords

  • Postoperative endophthalmitis
  • Multimodal imaging
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In context

Endophthalmitis

65 studies on the registry are indexed under Endophthalmitis; 9 are open to participants now.

This study's planned enrollment of 71 is below the median of 100 across 20 observational studies indexed under Endophthalmitis.

Browse Endophthalmitis studies →

Lead sponsor

Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Patients who have not signed the
  • Patients under 18 years.
  • Patients with endophthalmitis who do not meet the resolution criteria of the Mexican Endophthalmitis Study Group
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
71 participants (estimated)
Target follow-up
6 Weeks
Patient registry
Yes

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.

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What researchers measure

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).

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07175311
Lead sponsor
Asociación para Evitar la Ceguera en México
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Nov 1, 2024
Primary completion
Feb 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Sep 16, 2025

Study contacts

Raúl Velez Montoya, MD
Contact
rvelezmx@yahoo.com
(52) 55 5436 7335
Benjamín Aboytes Ríos, MD
Contact
benaborivers@gmail.com
4772329592
Raul Velez Montoya, MD
principal investigator · Asociación para Evitar la Ceguera en México

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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