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Completed

NCT Number: NCT05747547

Retinal Vascular Changes in Patients After Coronavirus Disease 2019 (COVID-19)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital Olomouc

Olomouc, Czechia

About this study

The retinal blood vessels are the only blood vessels in the body that can be observed directly. Patients with COVID-19 pneumonia have been shown to have reduced macular vessel density in the foveal region. As a result, some layers of the retina atrophy, reducing oxygen consumption by the retina. Based on this, it is expected that patients after COVID-19 pneumonia, or after a more severe course of the disease, will have normal arterial retinal oxygen saturation but higher venous retinal oxygen saturation and lower arterio-venous difference than patients after mild disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Central visual acuity

Diagnostic Test

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

Intraocular pressure measurement

Diagnostic Test

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

Slit lamp examination

Diagnostic 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).

Retinal oximetry

Diagnostic Test

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

Optical coherence tomography and angiography

Diagnostic Test

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

Primary outcomes

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

    Time frame: 3 months

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

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

    Time frame: 3 months

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

Secondary outcomes

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

    Time frame: 3 months

    90% of captured images of optical coherence tomography and angiography are useful for subsequent analysis.

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

    Time frame: 3 months

    The parameters analyzed by optical coherence tomography are central retinal thickness (µm), ganglion cell layer thickness (µm), retinal nerve fiber layer thickness (µm), choroid thickness (µm) in the macular region and optic nerve head retinal nerve fiber layer thickness (µm).

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

    Time frame: 3 months

    The parameter analyzed by optical coherence tomography angiography is the size of foveal avascular zone (µm2).

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

Retinal Vascular Changes in Patients After Coronavirus Disease 2019 (COVID-19) Based on Retinal Oximetry

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 28, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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