Lupus Erythematosus, Systemic Clinical Trial
— VascLupOfficial title:
Microvascular Ocular Changes of Systemic Lupus Erythematous
NCT number | NCT05863689 |
Other study ID # | VascLup |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 10, 2023 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 exclusion criteria: - established primary ocular diseases including a history of any retinal or optic nerve disease - presence of significant lens opacities (Lens Opacities Classification System III equal to or more stage 2) - retinopathy - high refractive error - ocular hypertension - previous intraocular surgery or trauma. |
Country | Name | City | State |
---|---|---|---|
Portugal | Centro Hospitalar Universitário de Santo António | Porto |
Lead Sponsor | Collaborator |
---|---|
Universidade do Porto | Centro Hospitalar Universitário de Santo António, Faculty of Medicine (FMUP) |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of retinal vessel density | Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography. | 6 months | |
Primary | Measurement of choroidal vascular index | Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging | 6 months |
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