NCT05863689

Microvascular Ocular Changes of Systemic Lupus Erythematous

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Universidade do Porto · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to to assess the ocular microvascular status of SLE patients with inactive disease and without ocular involvement. The main questions it aims to answer are: * the choroidal vascular status and thickness in SLE * the retinal macular microvascular status and structure in SLE Participants will be assessed with Spectral Domain Optical Coherence Tomography (SD-OCT). Researchers will compare SLE patients with healthy controls matched for age and sex.

Detailed description

The investigators will perform a cross-sectional evaluation of 25 SLE patients and 25 healthy controls matched for sex and age, using a Spectral Domain Optical Coherence Tomography (SD-OCT) with Enhanced Depth Imaging for choroidal assessment and with Angiography module to assess the retinal and choriocapillaris vasculature. Processing of image with external software will be performed to calculate the main outcomes: retinal vessel density, foveal avascular zone parameters and the choroidal vascular index.

Conditions

• Eye Manifestations
• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Spectralis SD-OCT	Optical Coherence Tomography

Timeline

• Start date: 2023-05-10
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2023-05-18
• Last updated: 2023-10-19

Locations

1 site across 1 country: Portugal