Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus (NCT07679776) | Clinical Trial Compass
By InvitationNot Applicable
Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus
China100 participantsStarted 2025-01-01
Plain-language 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 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 ;
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is enrolling by invitation only, can you find out whether I qualify to be invited, and what criteria they're using to select SLE patients for participation?
2This trial is measuring contrast sensitivity as a way to detect early visual problems in SLE — does my current disease activity or any medications I'm taking, like hydroxychloroquine, put me at higher risk for this kind of vision change that would make monitoring important for me?
3Since this appears to be an observational study rather than a treatment trial, what would actually happen during the visits — would I just be having vision tests done, and would I receive any feedback about my own results?
4If the study picks up early signs of visual dysfunction in my results, would that information be shared with you so we could act on it, or is it purely used for research purposes?
5Are there standard eye monitoring guidelines already recommended for SLE patients like me, and how would participating in this study compare to or complement the vision checks I should already be getting as part of my regular care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
contrast sensitivity
Timeframe: Day 1
Trial details
NCT IDNCT07679776
SponsorThe First Affiliated Hospital of Anhui Medical University