Microvascular Ocular Changes of Systemic Lupus Erythematous (VascLup)

Universidade do Porto

Status: Enrolling

Conditions: Eye Manifestations; Lupus Erythematosus, Systemic

Treatments: Diagnostic Test: Spectralis SD-OCT

Study type: Observational

Funder types: Other

Identifiers

NCT05863689

VascLup

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

50 participants in 2 patient groups

SLE Patients

Description:

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.

Treatment:

Diagnostic Test: Spectralis SD-OCT

Healthy Controls

Description:

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.

Treatment:

Diagnostic Test: Spectralis SD-OCT