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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05747547
• Other study ID #: 9/23
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: March 15, 2024

Study information

• Verified date: February 2024
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Central visual acuity
Measurement of central visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) optotypes or Snellen optotype chart.
• Intraocular pressure measurement
Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.
• 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).
• Retinal oximetry
Performing of retinal oximetry with an Oxymap T1 instrument (Oxymap ehf.) paired with a Topcon TRC-50DX retinal camera.
• Optical coherence tomography and angiography
Performing of optical coherence tomography and angiography with the Spectralis Optical Coherence Tomography Plus (Heidelberg Engineering).

Locations

Country	Name	City	State
Czechia	Department of Ophthalmology, University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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