Assessing eye blood vessel changes in lupus patients

Microvascular Ocular Changes of Systemic Lupus Erythematous

This study is testing how the tiny blood vessels in the eyes of people with lupus compare to those in healthy individuals to see if there are any differences.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Universidade do Porto (other)
• Locations: 1 site (Porto)
• Trial ID: NCT05863689 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the microvascular status of the eyes in patients with Systemic Lupus Erythematosus (SLE) who have inactive disease and no ocular involvement. Researchers will conduct a cross-sectional analysis involving 25 SLE patients and 25 healthy controls matched for age and sex. Using Spectral Domain Optical Coherence Tomography (SD-OCT), the study will assess choroidal vascular status and retinal microvascular structure, comparing the findings between SLE patients and healthy individuals. The main outcomes will include retinal vessel density and choroidal vascular index, processed through specialized software.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of SLE who are currently inactive and have no ocular involvement.

Not a fit: Patients with active SLE, significant ocular issues, or other systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of ocular health in lupus patients and inform future monitoring and treatment strategies.

How similar studies have performed: While there have been studies on ocular manifestations in lupus, this specific approach using SD-OCT for microvascular assessment is relatively novel.

Eligibility 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.

Where this trial is running

Porto

• Centro Hospitalar Universitário de Santo António — Porto, Portugal (RECRUITING)

Study contacts

• Principal investigator: André Ferreira, MD PhDc — Centro Hospitalar Universitário de Santo António
• Study coordinator: André Ferreira, MD PhDc

Conditions: Eye Manifestations, Lupus Erythematosus, Systemic