NCT07175311

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

July 29, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Postoperative endophthalmitisMultimodal imaging

Outcome Measures

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.

    The assessment will be performed at each visit (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).

Secondary Outcomes (2)

  • Fluorescein Angiography

    The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).

  • Fundus Photography

    The procedure may be performed at all study visits (7 days and 1 month after meeting the inactivation criteria for endophthalmitis).

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, 04030, Mexico

RECRUITING

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Study Officials

  • Raul Velez Montoya, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raúl Velez Montoya, MD

CONTACT

Benjamín Aboytes Ríos, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

September 16, 2025

Study Start

November 1, 2024

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations