NCT05635552

All Eyes on PCS - Analysis of the Retinal Microvasculature in Patients With Post-COVID-19 Syndrome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational, prospective study is to in depth analyze the retinal microvasculature in patients with Post-COVID-19 Syndrome (PCS). The main questions it aims to answer is: Do patients with PCS show a prolonged endothelial dysfunction when compared with fully COVID-19 recovered participants? Does symptom severity in PCS patients correlate with the extend of endothelial dysfunction? Do these changes correlate with improvement in symptoms in the prospective observation?

Detailed description

The investigators will recruit patients with PCS, fully COVID-19 recovered participants and COVID-19 infection naïve participants. After comprehensive clarification and given written informed consent, measurements will take place in the Klinikum rechts der Isar. To evaluate the retinal microvasculature dynamic retinal vessel analysis (DVA) and optical coherence tomography (OCT) are used. Patient reported outcomes (PROM) of PCS typical symptoms will be collected using standardized questionnaires. To ensure data quality the investigators will use standard operating procedures (SOP) for both technical measurements and data collection. For DVA measurements all examiners will be trained by a single experienced supervisor and must reach high image accuracy and quality in at least 10 volunteers. Examiners are only involved in data acquisition.

Conditions

• Long Covid19
• Post COVID-19 Condition
• Endothelial Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dynamic retinal vessel analysis (DVA)	DVA is an established, non-invasive tool to measure the responsiveness of retinal vessels to flickering light. In addition static retinal vessel parameters are recorded.
DIAGNOSTIC_TEST	Optical coherence tomography (OCT)	OCT is an imaging technique which applies low-coherence light to capture high resolution images from the ocular fundus.
DIAGNOSTIC_TEST	Biochemistry and immune phenotyping	Blood sample collection for clinical chemistry and isolation of PBMCs for FACS analysis.
DIAGNOSTIC_TEST	Handgrip strength test	Measure the maximum isometric strength of the hand and forearm muscles and their fatiguability.
DIAGNOSTIC_TEST	Questionnaires (Patient reported outcomes)	The questionnaires evaluate anxiety, depression, chronic fatigue, quality of life, and post-covid typical symptoms

Timeline

• Start date: 2022-10-17
• Primary completion: 2023-02-21
• Completion: 2023-07-21
• First posted: 2022-12-02
• Last updated: 2022-12-02

Locations

1 site across 1 country: Germany