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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date April 2023
Source Universidade do Porto
Contact André Ferreira, MD PhDc
Phone 222 077 500
Email andre.ferreira@live.com.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Spectralis SD-OCT
Optical Coherence Tomography

Locations

Country Name City State
Portugal Centro Hospitalar Universitário de Santo António Porto

Sponsors (3)

Lead Sponsor Collaborator
Universidade do Porto Centro Hospitalar Universitário de Santo António, Faculty of Medicine (FMUP)

Country where clinical trial is conducted

Portugal, 

Outcome

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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