Microvascular Ocular Changes of Systemic Lupus Erythematous

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

• 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.

Locations
Other Locations
Portugal
Centro Hospitalar Universitário de Santo António
RECRUITING
Porto
Contact Information
Primary
André Ferreira, MD PhDc
andre.ferreira@live.com.pt
222 077 500
Backup
Janete Santos, PhD
investigaclinica@med.up.pt
(+351) 225 513 600
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Universidade do Porto
Collaborators: Centro Hospitalar Universitário de Santo António

This content was sourced from clinicaltrials.gov