AS-OCT Study of Cornea and Tear Film Parameters in SLE Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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&#39;s syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) . Schirmer&#39;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)

Official Title
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Anterior Segment Optical Coherence Tomography Study of Cornea and Tear Film Parameters in Systemic Lupus Erythematous Patients

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Diagnostic Test: Anterior Segment OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old.. Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination Exclusion Criteria: 1. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery. 2. Patients with history of any corneal refractive surgery as LASIK, PRK. 3. Patients with significant media opacity as corneal opacity, cataract. 4. Patients with ocular diseases as glaucoma, uveitis. 5. Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion. 6. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 patients SLE with dry eye<br>Anterior segment OCT for SLE patients with dry eye | Diagnostic Test: Anterior Segment OCT<br>* AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.<br>|
| 30 patients SLE without dry eye<br>Anterior segment OCT for SLE patients without dry eye | Diagnostic Test: Anterior Segment OCT<br>* AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.<br>|
| 50 normal subjects as control group of similar age and gender<br>Anterior segment OCT for normal subjects | Diagnostic Test: Anterior Segment OCT<br>* AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior segment optical coherence tomography, tear film, dry eye, systemic lupus erythematous