Clinical trial NCT05747547: Retinal Vascular Changes in Patients After Coronavirus Disease 2019 (COVID-19)
Official title: Retinal Vascular Changes in Patients After Coronavirus Disease 2019 (COVID-19) Based on Retinal Oximetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2023-02-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful performing of retinal oximetry images in 90% of enrolled patients.
timeFrame: 3 months
measure: Successful analysis of retinal oxygen saturation in 90% of enrolled patients.
timeFrame: 3 months
Secondary outcomes:
measure: Successful performing of optical coherence tomography and angiography in 90% of enrolled patients.
timeFrame: 3 months
measure: Successful analysis of optical coherence tomography in 90% of enrolled patients.
timeFrame: 3 months
measure: Successful analysis of optical coherence tomography angiography in 90% of enrolled patients.
timeFrame: 3 months
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Department of Ophthalmology, University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc and Palacky University Olomouc
name: Zuzana Schreiberova, MD
role: PRINCIPAL_INVESTIGATOR
References: