Microvascular Ocular Changes of Systemic Lupus Erythematous

NCT05863689 | Unknown

• 1 other identifier: VascLup
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Manifestations; Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Spectralis SD-OCT DIAGNOSTIC_TEST

Optical Coherence Tomography

Healthy Controls; SLE Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• no systemic diseases
• age between 18 and 80 years

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar Universitário de Santo António: collaborator

Study Sites (1)

Centro Hospitalar Universitário de Santo António

Porto, 4099, Portugal

RECRUITING

Related Publications (1)

• Ferreira A, Viveiros L, Faria R, Braganca F, Abreu AC, Santos D, Furtado MJ, Lume M, Meneres P, Andrade JP. Retinal microvascular changes in systemic lupus erythematosus assessed by optical coherence tomography angiography. Int J Retina Vitreous. 2024 Dec 18;10(1):94. doi: 10.1186/s40942-024-00617-6.

  PMID: 39696716 DERIVED

MeSH Terms

Conditions

Eye Manifestations; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• André Ferreira, MD PhDc

  Centro Hospitalar Universitário de Santo António

  PRINCIPAL INVESTIGATOR

Central Study Contacts

André Ferreira, MD PhDc

CONTACT

222 077 500; andre.ferreira@live.com.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 18, 2023
• Study Start: May 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)