VascLup: Microvascular Ocular Changes of Systemic Lupus Erythematous

• Sponsor: Universidade do Porto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05863689
• Collaborator: Centro Hospitalar Universitário de Santo António (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 30.8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Manifestations; Lupus Erythematosus, Systemic	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Microvascular Ocular Changes of Systemic Lupus Erythematous
• Actual Study Start Date: May 10, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Measurement of retinal vessel density [6 months]

   Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.

2. Measurement of choroidal vascular index [6 months]

   Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar Universitário de Santo António	Porto		Portugal	4099

Sponsors and Collaborators

• Universidade do Porto
• Centro Hospitalar Universitário de Santo António

Investigators

• Principal Investigator: André Ferreira, MD PhDc, Centro Hospitalar Universitário de Santo António

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidade do Porto
• ClinicalTrials.gov Identifier: NCT05863689
• Other Study ID Numbers: VascLup
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Eye Manifestations; Lupus Erythematosus, Systemic

Study Results

No Results Posted as of May 18, 2023