An observational study in Systemic Lupus Erythematosus, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Minia University · Observational
The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in SLE patients and compared to healthy subjects of similar age and gender.
Systemic lupus erythematous (SLE) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . SLE has a global prevalence of 0.3 to 23.2 cases per 100,000. Women are more likely than men to develop the disease. Four out of the following 11 diagnostic criteria are sufficient for the diagnosis of SLE, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3)
Ocular manifestations occur in about one third of SLE patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. Scleritis, retinal vasculitis (which is often associated with CNS lupus), and papillitis are considered as the most serious ocular manifestations. (4)
Corneal involvement in SLE affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by Sjögren\'s syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) .
Schirmer\'s test and fluorescein breakup time test (FBUT) are two common clinical tests used to analyze tear film. (6,7) Using an in vivo, non- contact technique, anterior segment optical coherence tomography (AS- OCT) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 100 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Residents of Minia Governorate diagnosed with SLE and healthy one
Exclusion Criteria:
Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.
Anterior segment OCT for SLE patients with dry eye
Diagnostic Test: Anterior Segment OCT
Anterior segment OCT for SLE patients without dry eye
Diagnostic Test: Anterior Segment OCT
Anterior segment OCT for normal subjects
Diagnostic Test: Anterior Segment OCT
AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.
Measurement of Tear meniscus
to measure lower tear meniscus height and area and depth with AS-OCT and comparing results between 3 groups; SLE patients with dry eye, SLE patients without dry eye and normal subjects.
Time frame: 3 months
Measurement of corneal structural changes
To measure corneal Thickness, epithelial thickness and stromal thickness using AS-OCT comparing results between 3 groups; SLE patients with dry eye, SLE patients without dry eye and normal subjects.
Time frame: 3 months
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Minia University