Microvascular Ocular Changes of Systemic Lupus Erythematous

Last updated: October 18, 2023
Sponsor: Universidade do Porto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cutaneous Lupus Erythematosus

Lupus

Systemic Lupus Erythematosus

Treatment

Spectralis SD-OCT

Clinical Study ID

NCT05863689
VascLup
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Systemic inclusion criteria for SLE patients:

  • fulfill the 2019 European League Against Rheumatism (EULAR) / American College ofRheumatology (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

Exclusion

Systemic exclusion criteria:

  • arterial hypertension (defined as systolic blood pressure higher than 140 mm Hg ordiastolic 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 Goldmannapplanation 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 nervedisease
  • presence of significant lens opacities (Lens Opacities Classification System III equalto or more stage 2)
  • retinopathy
  • high refractive error
  • ocular hypertension
  • previous intraocular surgery or trauma.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Spectralis SD-OCT
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Centro Hospitalar Universitário de Santo António

    Porto, 4099
    Portugal

    Active - Recruiting

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