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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Central visual acuity; Diagnostic test: Intraocular pressure measurement; Diagnostic test: Slit lamp examination; Diagnostic test: Retinal oximetry; Diagnostic test: Optical coherence tomography and angiography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia
    • Department of Ophthalmology, University Hospital Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 acuity; Measurement of central visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) optotypes or Snellen optotype chart.; Diagnostic test: Intraocular pressure measurement; Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.; Diagnostic test: Slit lamp examination; 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).; Diagnostic test: Retinal oximetry; Performing of retinal oximetry with an Oxymap T1 instrument (Oxymap ehf.) paired with a Topcon TRC-50DX retinal camera.; Diagnostic test: Optical coherence tomography and angiography; Performing of optical coherence tomography and angiography with the Spectralis Optical Coherence Tomography Plus (Heidelberg Engineering).
moderate disease; patients with laboratory-confirmed SARS-CoV2-infection and radiology-confirmed pneumonia who did not require extracorporeal membrane oxygenation	Diagnostic test: Central visual acuity; Measurement of central visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) optotypes or Snellen optotype chart.; Diagnostic test: Intraocular pressure measurement; Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.; Diagnostic test: Slit lamp examination; 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).; Diagnostic test: Retinal oximetry; Performing of retinal oximetry with an Oxymap T1 instrument (Oxymap ehf.) paired with a Topcon TRC-50DX retinal camera.; Diagnostic test: Optical coherence tomography and angiography; Performing of optical coherence tomography and angiography with the Spectralis Optical Coherence Tomography Plus (Heidelberg Engineering).
severe disease; patients with laboratory-confirmed SARS-CoV2-infection and acute respiratory distress syndrome who required extracorporeal membrane oxygenation	Diagnostic test: Central visual acuity; Measurement of central visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) optotypes or Snellen optotype chart.; Diagnostic test: Intraocular pressure measurement; Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.; Diagnostic test: Slit lamp examination; 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).; Diagnostic test: Retinal oximetry; Performing of retinal oximetry with an Oxymap T1 instrument (Oxymap ehf.) paired with a Topcon TRC-50DX retinal camera.; Diagnostic test: Optical coherence tomography and angiography; Performing of optical coherence tomography and angiography with the Spectralis Optical Coherence Tomography Plus (Heidelberg Engineering).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful performing of optical coherence tomography and angiography in 90% of enrolled patients.	90% of captured images of optical coherence tomography and angiography are useful for subsequent analysis.	3 months
Successful analysis of optical coherence tomography in 90% of enrolled patients.	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 months
Successful analysis of optical coherence tomography angiography in 90% of enrolled patients.	The parameter analyzed by optical coherence tomography angiography is the size of foveal avascular zone (µm2).	3 months

Collaborators and Investigators

• Sponsor: University Hospital Olomouc
• Collaborators: Palacky University
• Investigators: Principal Investigator: Zuzana Schreiberova, MD, University Hospital Olomouc and Palacky University Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 9/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No