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Microvascular Ocular Changes of Systemic Lupus Erythematous

Microvascular Ocular Changes of Systemic Lupus Erythematous

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05863689
Acronym
VascLup
Enrollment
50
Registered
2023-05-18
Start date
2023-05-10
Completion date
2025-12-31
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Manifestations, Lupus Erythematosus, Systemic

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.

Interventions

DIAGNOSTIC_TESTSpectralis SD-OCT

Optical Coherence Tomography

Sponsors

Centro Hospitalar Universitário de Santo António
CollaboratorOTHER
Universidade do Porto
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Systemic inclusion criteria for SLE patients: * fulfill the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for the diagnosis of SLE * age between 18 and 80 years * no disease activity (SLEDAI \<3) * no risk factors for drug toxicity Systemic inclusion criteria for control group: * no systemic diseases * age between 18 and 80 years Systemic

Exclusion criteria

* arterial hypertension (defined as systolic blood pressure higher than 140 mm Hg or diastolic blood pressure higher than 90 mm Hg) or medically treatment for hypertension * diabetes mellitus * nephropathy or other documented microvascular complications * secondary Sjögren syndrome * local or systemic inflammatory diseases (other than SLE) * smokers of more than 20 cigarettes a day * pregnancy. Ophthalmological inclusion criteria: * best-corrected visual acuity ≤ 0.3 LogMAR * intra-ocular pressure \<21 mm Hg on diurnal testing with measurements using Goldmann applanation tonometry * spherical equivalent refractive error between -6.0 and +4.0 diopters * open anterior chamber angle on slit lamp examination. Ophthalmic

Design outcomes

Primary

MeasureTime frameDescription
Measurement of retinal vessel density6 monthsComparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.
Measurement of choroidal vascular index6 monthsComparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging

Countries

Portugal

Contacts

Primary ContactAndré Ferreira, MD PhDc
andre.ferreira@live.com.pt222 077 500
Backup ContactJanete Santos, PhD
investigaclinica@med.up.pt(+351) 225 513 600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026