Microvascular Ocular Changes of Systemic Lupus Erythematous

Recruiting

• Conditions: Eye Manifestations; Lupus Erythematosus, Systemic
• Interventions: Diagnostic Test: Spectralis SD-OCT

• Registration Number: NCT05863689
• Lead Sponsor: Universidade do Porto

Brief 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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-28
• Study Start: 2023-05-10
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-18
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Spectralis SD-OCT	Healthy controls matched for sex and age with SLE Patients. Ophthalmological inclusion criteria: (1) best-corrected visual acuity ≤ 0.3 LogMAR, (2) intra-ocular pressure \<21 mm Hg on diurnal testing with measurements using Goldmann applanation tonometry, (3) spherical equivalent refractive error between -6.0 and +4.0 diopters, and (4) open anterior chamber angle on slit lamp examination.
SLE Patients	Spectralis SD-OCT	Patients fulfilling the 1997 revised American College of Rheumatology (ACR) criteria for the diagnosis of SLE (21) and aged between 18 and 80 years old. Ophthalmological inclusion criteria: (1) best-corrected visual acuity ≤ 0.3 LogMAR, (2) intra-ocular pressure \<21 mm Hg on diurnal testing with measurements using Goldmann applanation tonometry, (3) spherical equivalent refractive error between -6.0 and +4.0 diopters, and (4) open anterior chamber angle on slit lamp examination.

Primary Outcome Measures

Name	Time	Method
Measurement of choroidal vascular index	6 months	Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging
Measurement of retinal vessel density	6 months	Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.

Trial Locations

Locations (1)

Centro Hospitalar Universitário de Santo António; 🇵🇹 Porto, Portugal