Retinal Neurovascular Coupling in Patients Previously Infected With COVID-19

NCT05650905 | Recruiting

• 1 other identifier: OPHT-180520
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The Study objective is to measure retinal neurovascular coupling and blood flow parameters in patients previously infected with COVID-19, long COVID-19 and healthy age- and sex- matched control subjects

Conditions

COVID-19; Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• Retinal neurovascular coupling

  Retinal neurovascular coupling will be assessed using the DVA

  Day 0

Secondary Outcomes (13)

• Retinal vessel diameters

  Day 0

• Retinal oxygen saturation

  Day 0

• Retinal blood velocities

  Day 0

• Retinal blood flow

  Day 0

• Ocular perfusion pressure

  Day 0

Study Arms (3)

subjects previously infected with COVID-19

subjects previously infected with COVID-19

Device: Dynamic Vessel Analyzer (DVA); Device: Fourier domain optical coherence tomography (FDOCT); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG); Diagnostic Test: Proteomics and Metabolites in Plasma, tear fluid and finger sweat

subjects with long COVID-19

subjects with long COVID-19 according to the WHO-guideline

Device: Dynamic Vessel Analyzer (DVA); Device: Fourier domain optical coherence tomography (FDOCT); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG); Diagnostic Test: Proteomics and Metabolites in Plasma, tear fluid and finger sweat

healthy age-and sex- matched control subjects with no history of COVID-19 infection

healthy age-and sex- matched control subjects with no history of COVID-19 infection

Device: Dynamic Vessel Analyzer (DVA); Device: Fourier domain optical coherence tomography (FDOCT); Device: Optical coherence tomography (OCT); Device: Laser Speckle Flowgraphy (LSFG); Diagnostic Test: Proteomics and Metabolites in Plasma, tear fluid and finger sweat

Interventions

Dynamic Vessel Analyzer (DVA) DEVICE

Retinal neurovascular coupling, Retinal vessel diameters and Retinal oxygen saturation will be assessed using the DVA

healthy age-and sex- matched control subjects with no history of COVID-19 infection; subjects previously infected with COVID-19; subjects with long COVID-19

Fourier domain optical coherence tomography (FDOCT) DEVICE

Retinal blood velocities and Retinal blood flow will be assessed using the FDOCT

healthy age-and sex- matched control subjects with no history of COVID-19 infection; subjects previously infected with COVID-19; subjects with long COVID-19

Optical coherence tomography (OCT) DEVICE

Retinal nerve fiber layer thickness, Central retinal thickness and Retinal vessel density will be assessed using the OCT

healthy age-and sex- matched control subjects with no history of COVID-19 infection; subjects previously infected with COVID-19; subjects with long COVID-19

Laser Speckle Flowgraphy (LSFG) DEVICE

Normalized blur and Relative flow volume will be assessed using the LSFG

healthy age-and sex- matched control subjects with no history of COVID-19 infection; subjects previously infected with COVID-19; subjects with long COVID-19

Proteomics and Metabolites in Plasma, tear fluid and finger sweat DIAGNOSTIC_TEST

Proteomics and Metabolites in Plasma, tear fluid and finger sweat will be assessed using a Blooddraw, filter paper and Schirmer-test

healthy age-and sex- matched control subjects with no history of COVID-19 infection; subjects previously infected with COVID-19; subjects with long COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 90 subjects will be included: 30 subjects previously infected with COVID-19 30 subjects with long COVID-19 30 age-and sex- matched subjects with no history of COVID-19 infection

You may qualify if:

• Men and women aged over 18 years
• Non-smokers
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
• No previous history of COVID-19 infection
• Negative testing for SARS-CoV-2 seroprevalence using nucleocapsid antibody tests
• Negative PCR test for SARS-CoV-2
• Normal ophthalmic findings, ametropy \< 6 Dpt.
• Men and women aged over 18 years
• Non-smokers
• History of COVID-19 infection (confirmed by a positive PCR test for SARS-CoV2 in the medical history) within the last 6 months
• Positive testing for SARS-CoV-2 seroprevalence using spike protein IgG antibody tests
• Negative PCR test for SARS-CoV-2
• Men and women aged over 18 years
• Non-smokers
• History of COVID-19 infection (confirmed by a positive PCR test for SARS-CoV2 in the medical history)

You may not qualify if:

• Any of the following will exclude a healthy control subject from the study:
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Presence or history of a severe medical condition as judged by the clinical investigator
• Participation in a clinical trial in the 3 weeks preceding the study
• Blood donation during the previous three weeks
• History or family history of epilepsy
• Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
• Best corrected visual acuity \< 0.8 Snellen
• Pregnancy, planned pregnancy or lactatin
• History of epilepsia
• Any of the following will exclude a subject with history of COVID-19 infection from the study:
• Blood donation during the previous three weeks
• History or family history of epilepsy
• Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
• Best corrected visual acuity \< 0.8 Snellen

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Pai V, Bileck A, Hommer N, Janku P, Lindner T, Kauer V, Rumpf B, Haslacher H, Hagn G, Meier-Menches SM, Schmetterer L, Schmidl D, Gerner C, Garhofer G. Impaired retinal oxygen metabolism and perfusion are accompanied by plasma protein and lipid alterations in recovered COVID-19 patients. Sci Rep. 2024 Apr 10;14(1):8395. doi: 10.1038/s41598-024-56834-4.

  PMID: 38600099 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 14, 2022
• Study Start: July 26, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2024-12

Locations

AU (1)