NCT05747547

Brief Summary

The study examines changes in retinal oximetry in patients after COVID-19 disease. It aims to analyze and quantify possible retinal microvascular abnormalities that may result from possible post-inflammatory damage to the endothelium of the vessels associated with COVID-19 disease. Retinal vascular involvement may indicate similar changes in the vascular system in other organs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

February 24, 2023

Last Update Submit

May 22, 2025

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • Successful performing of retinal oximetry images in 90% of enrolled patients.

    90% of captured fundus images of retinal oximetry are useful for subsequent analysis.

    3 months

  • Successful analysis of retinal oxygen saturation in 90% of enrolled patients.

    The parameters analyzed by retinal oximetry are arterial retinal oxygen saturation (%), venous retinal oxygen saturation (%), arterio-venous difference (%), arteriolar and venular diameter (µm).

    3 months

Secondary Outcomes (3)

  • Successful performing of optical coherence tomography and angiography in 90% of enrolled patients.

    3 months

  • Successful analysis of optical coherence tomography in 90% of enrolled patients.

    3 months

  • Successful analysis of optical coherence tomography angiography in 90% of enrolled patients.

    3 months

Study Arms (3)

mild disease

asymptomatic or paucisymptomatic patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection (SARS-CoV2-infection) who received outpatient care

Diagnostic Test: Central visual acuityDiagnostic Test: Intraocular pressure measurementDiagnostic Test: Slit lamp examinationDiagnostic Test: Retinal oximetryDiagnostic Test: Optical coherence tomography and angiography

moderate disease

patients with laboratory-confirmed SARS-CoV2-infection and radiology-confirmed pneumonia who did not require extracorporeal membrane oxygenation

Diagnostic Test: Central visual acuityDiagnostic Test: Intraocular pressure measurementDiagnostic Test: Slit lamp examinationDiagnostic Test: Retinal oximetryDiagnostic Test: Optical coherence tomography and angiography

severe disease

patients with laboratory-confirmed SARS-CoV2-infection and acute respiratory distress syndrome who required extracorporeal membrane oxygenation

Diagnostic Test: Central visual acuityDiagnostic Test: Intraocular pressure measurementDiagnostic Test: Slit lamp examinationDiagnostic Test: Retinal oximetryDiagnostic Test: Optical coherence tomography and angiography

Interventions

Central visual acuityDIAGNOSTIC_TEST

Measurement of central visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) optotypes or Snellen optotype chart.

mild diseasemoderate diseasesevere disease
Slit lamp examinationDIAGNOSTIC_TEST

Slit lamp examination of the anterior and posterior segment of the eye after pharmacological dilation of the pupil using application of short-time mydriatics (1% tropicamide and 10% phenylephrine).

mild diseasemoderate diseasesevere disease
Retinal oximetryDIAGNOSTIC_TEST

Performing of retinal oximetry with an Oxymap T1 instrument (Oxymap ehf.) paired with a Topcon TRC-50DX retinal camera.

mild diseasemoderate diseasesevere disease
Optical coherence tomography and angiographyDIAGNOSTIC_TEST

Performing of optical coherence tomography and angiography with the Spectralis Optical Coherence Tomography Plus (Heidelberg Engineering).

mild diseasemoderate diseasesevere disease
Intraocular pressure measurementDIAGNOSTIC_TEST

Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.

mild diseasemoderate diseasesevere disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Groups will be recruited from patients examined at the Department of Respiratory Diseases and Tuberculosis of University Hospital Olomouc at the outpatient check-up.

You may qualify if:

  • age over 18 years
  • history of laboratory-confirmed SARS-CoV2-infection
  • transparent ocular media allowing for fundus photography
  • signed informed consent

You may not qualify if:

  • known eye disease that has been shown to affect retinal oxygen saturation (diabetic retinopathy, vascular occlusions, use of antiglaucoma drugs)
  • any other serious eye disease (advanced or decompensated glaucoma, retinitis pigmentosa, age-related macular degeneration, ocular tumors)
  • reduced transparency of the ocular media limiting the visualization of the ocular background and preventing a good quality image from being taken (severe dry eye syndrome, corneal scarring, cataract, significant vitreous haze, vitreous hemorrhage)
  • significant refractive error not allowing for sharpening of imaging examinations
  • previous intraocular surgery except cataract surgery if performed more than 3 months before the examination
  • previous intravitreal application of anti-vascular endothelial growth factor therapy or laser photocoagulation of the retina
  • previous severe eye injury
  • acute eye infection
  • known systemic disease affecting retinal oxygen saturation or causing changes in the ocular background (chronic obstructive pulmonary disease, multiple myeloma, malignant hypertension, hyperglobulinemia)
  • pregnancy, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital Olomouc

Olomouc, Czechia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Tonometry, OcularSlit Lamp MicroscopyTomography, Optical CoherenceAngiography

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisTomography, OpticalOptical ImagingDiagnostic ImagingTomographyInvestigative TechniquesRadiographyDiagnostic Techniques, Cardiovascular

Study Officials

  • Zuzana Schreiberova, MD

    University Hospital Olomouc and Palacky University Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2023

First Posted

February 28, 2023

Study Start

August 1, 2022

Primary Completion

May 1, 2023

Study Completion

October 1, 2024

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)