Eye ManifestationsVascLupNCT05863689
Microvascular Ocular Changes of Systemic Lupus Erythematous
An observational study of Eye Manifestations and Lupus Erythematosus, Systemic, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Manifestations, Lupus Erythematosus, Systemic
- What is being tested?
- Spectralis SD-OCT
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 10 May 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Universitário de Santo António
Porto, 4099
André Ferreira, MD PhDc, +351 22 207 7500, andre.ferreira@live.com.pt
About this study
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.
Read the 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.
- Conditions
- Eye Manifestations, Lupus Erythematosus, Systemic
- Being tested
- Spectralis SD-OCT
- Medical subject headings
- Eye Manifestations, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectralis SD-OCTDiagnostic test
Optical Coherence Tomography
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Spectralis SD-OCT | |
| 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. Receives: Diagnostic Test: Spectralis SD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of retinal vessel density
Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.
Measured: 6 months
Measurement of choroidal vascular index
Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start10 May 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Universitário de Santo António
- Responsible party
- Sponsor
- Investigators
- André Ferreira, MD PhDc, Principal investigator, Centro Hospitalar Universitário de Santo António
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863689
- Sponsor's protocol ID
- VascLup
- Acronym
- VascLup
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39696716
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Ocular Changes of Systemic Lupus Erythematous
- ClinicalTrials.gov ID
- NCT05863689
- Acronym / sponsor ID
- VascLup / VascLup
- Conditions
- Eye Manifestations, Lupus Erythematosus, Systemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar Universitário de Santo António
- Study start
- 10 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE Patients | – | Diagnostic Test: Spectralis SD-OCTPatients 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 | – | Diagnostic Test: Spectralis SD-OCTHealthy 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectralis SD-OCTOptical Coherence Tomography | Diagnostic test | Healthy Controls, SLE Patients |
Primary outcome
Measurement of retinal vessel density
Time frame: 6 months
Comparison of retinal vessel density of superficial and deep plexuses between SLE patients and healthy controls using OCT Angiography.
Measurement of choroidal vascular index
Time frame: 6 months
Comparison of choroidal vascular index between SLE patients and healthy controls using OCT with Enhance Depth Imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 39696716Ferreira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Ferreira, MD PhDc principal investigator
Centro Hospitalar Universitário de Santo António
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Manifestations and Lupus Erythematosus, Systemic, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André Ferreira, MD PhDc (222 077 500, andre.ferreira@live.com.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of retinal vessel density (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.