Microvascular Ocular Changes of Systemic Lupus Erythematous (VascLup)

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.

Study Overview

• Status: Recruiting
• Conditions: Lupus Erythematosus, Systemic; Eye Manifestations
• Intervention / Treatment: Diagnostic test: Spectralis SD-OCT

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: André Ferreira, MD PhDc; Phone Number: 222 077 500; Email: andre.ferreira@live.com.pt
• Study Contact Backup: Name: Janete Santos, PhD; Phone Number: (+351) 225 513 600; Email: investigaclinica@med.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4099
    • Recruiting
    • Centro Hospitalar Universitário de Santo António
    • Contact: André Ferreira, MD PhDc; Phone Number: +351 22 207 7500; Email: andre.ferreira@live.com.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria for the diagnosis of SLE and aged between 18 and 80 years old and an age and sex-matched group of healthy controls.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SLE Patients; 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.	Diagnostic test: Spectralis SD-OCT; Optical Coherence Tomography
Healthy Controls; 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.	Diagnostic test: Spectralis SD-OCT; Optical Coherence Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Measurement of choroidal vascular index	Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging	6 months

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar Universitário de Santo António; Faculty of Medicine (FMUP)
• Investigators: Principal Investigator: André Ferreira, MD PhDc, Centro Hospitalar Universitário de Santo António

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Eye Manifestations
• Other Study ID Numbers: VascLup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No