Systemic Lupus Erythematosus (SLE)NCT07679776
Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus (SLE) and Visual Function, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
OCT, OCTA, fundus photography, and fundus autofluorescence ( FAF ) were used to observe the fundus physiological indexes of normal subjects and SLE patients, to explore the differences of subclinical retinal damage in SLE patients with different degrees of disease activity, to summarize the changes of subclinical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Visual Function
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 50 patients ( 100 eyes ) who met the inclusion criteria were collected from the patients diagnosed with SLE in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Anhui Medical University. Among them, the diagnosis of SLE is based on the 2019 European Rheumatism Association ( EULAR ) / American Rheumatism Association ( ACR ) SLE diagnostic criteria. At the same time, 50 age-matched healthy adults ( 100 eyes ) were recruited as the normal control group.
Who may be able to join
- the best corrected visual acuity ( BCVA ) of all cases must be ≥ 1.0 according to the international standard visual acuity char;
- intraocular pressure ( IOP ) in the normal range, namely 10 mmHg ≤ IOP ≤ 21 mmHg ;
- visual field meter examination center and peripheral visual field without defect ;
- no degeneration of fundus retina ;
Who cannot join
- obvious abnormality in cranial MRI ;
- history of glaucoma, cataract, retinal vascular disease, retinitis pigmentosa and other eye diseases ;
- history of refractive surgery such as corneal refractive surgery and cataract surgery ;
- other major disease history or systemic lesions affecting the eye ;
- history of disease affecting cognitive function, can understand and cooperate with the examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
- OCT, OCTA, fundus photography, and fundus autofluorescence ( FAF ) were used to observe the fundus physiological indexes of normal subjects and SLE patients, to explore the differences of subclinical retinal damage in SLE patients with different degrees of disease activity, to summarize the changes of subclinical retina in SLE patients without organic retinopathy, and to evaluate its correlation with disease activity, which is of great significance for improving the prognosis of visual function and improving the quality of life in SLE patients.
- By evaluating the visual psychophysical indicators, mainly the visual function test results of different colors and different frequencies, reflecting the functional status of the retina and the degree and characteristics of functional impairment in SLE patients with different degrees of disease activity, in order to screen out the clinical markers of SLE fundus lesions, and provide a reliable reference for the prevention and early intervention of visual impairment.
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLE | SLE patients without retinopathy | |
| Control | Normal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
contrast sensitivity
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixia Feng, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679776
- Sponsor's protocol ID
- PJ2025-06-26
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations. Participants did not consent to data sharing in the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07679776
- Acronym / sponsor ID
- PJ2025-06-26
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Jul 2026 (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.
- OCT, OCTA, fundus photography, and fundus autofluorescence ( FAF ) were used to observe the fundus physiological indexes of normal subjects and SLE patients, to explore the differences of subclinical retinal damage in SLE patients with different degrees of disease activity, to summarize the changes of subclinical retina in SLE patients without organic retinopathy, and to evaluate its correlation with disease activity, which is of great significance for improving the prognosis of visual function and improving the quality of life in SLE patients.
- By evaluating the visual psychophysical indicators, mainly the visual function test results of different colors and different frequencies, reflecting the functional status of the retina and the degree and characteristics of functional impairment in SLE patients with different degrees of disease activity, in order to screen out the clinical markers of SLE fundus lesions, and provide a reliable reference for the prevention and early intervention of visual impairment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE | – | –SLE patients without retinopathy |
| Control | – | –Normal group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 50 patients ( 100 eyes ) who met the inclusion criteria were collected from the patients diagnosed with SLE in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Anhui Medical University. Among them, the diagnosis of SLE is based on the 2019 European Rheumatism Association ( EULAR ) / American Rheumatism Association ( ACR ) SLE diagnostic criteria. At the same time, 50 age-matched healthy adults ( 100 eyes ) were recruited as the normal control group.
Key inclusion criteria (4 listed)
- the best corrected visual acuity ( BCVA ) of all cases must be ≥ 1.0 according to the international standard visual acuity char;
- intraocular pressure ( IOP ) in the normal range, namely 10 mmHg ≤ IOP ≤ 21 mmHg ;
- visual field meter examination center and peripheral visual field without defect ;
- no degeneration of fundus retina ;
Key exclusion criteria (5 listed)
- obvious abnormality in cranial MRI ;
- history of glaucoma, cataract, retinal vascular disease, retinitis pigmentosa and other eye diseases ;
- history of refractive surgery such as corneal refractive surgery and cataract surgery ;
- other major disease history or systemic lesions affecting the eye ;
- history of disease affecting cognitive function, can understand and cooperate with the examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
contrast sensitivity
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations. Participants did not consent to data sharing in the informed consent form.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Lupus Erythematosus (SLE) and Visual Function, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
contrast sensitivity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.