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| Name | Class |
|---|---|
| Centro Hospitalar UniversitĂ¡rio de Santo AntĂ³nio | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectralis SD-OCT | Diagnostic Test | Optical Coherence Tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Systemic inclusion criteria for SLE patients:
Systemic inclusion criteria for control group:
Systemic exclusion criteria:
Ophthalmological inclusion criteria:
Ophthalmic exclusion criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| AndrĂ© Ferreira, MD PhDc | Centro Hospitalar UniversitĂ¡rio de Santo AntĂ³nio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar UniversitĂ¡rio de Santo AntĂ³nio | Recruiting | Porto | 4099 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39696716 | Derived | 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. |
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| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |