AS-OCT Study of Cornea and Tear Film Parameters in Juvenile SLE Patients
NCT ID: NCT05015465
Last Updated: 2021-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
140 participants
OBSERVATIONAL
2020-07-01
2021-11-01
Brief Summary
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Detailed Description
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Ocular manifestations occur in about one third of juvenile 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 juvenile 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)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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70 patients with juvenile SLE.
Anterior segment OCT for juvenile SLE patients.
Anterior Segment OCT
AS-OCT for juvenile SLE patients and compare them with normal subjects
70 normal subjects as control group of similar age and gender
Anterior segment OCT for normal subjects
Anterior Segment OCT
AS-OCT for juvenile SLE patients and compare them with normal subjects
Interventions
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Anterior Segment OCT
AS-OCT for juvenile SLE patients and compare them with normal subjects
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
10 Years
18 Years
ALL
Yes
Sponsors
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Minia University
OTHER
Responsible Party
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Mohamed Salah
Principal Investigator
Principal Investigators
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Mohamed Salah, MD
Role: PRINCIPAL_INVESTIGATOR
Minia University Hospital
Locations
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Minia University Hospital
Minya, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Palejwala NV, Walia HS, Yeh S. Ocular manifestations of systemic lupus erythematosus: a review of the literature. Autoimmune Dis. 2012;2012:290898. doi: 10.1155/2012/290898. Epub 2012 Jul 2.
Rees F, Doherty M, Grainge MJ, Lanyon P, Zhang W. The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies. Rheumatology (Oxford). 2017 Nov 1;56(11):1945-1961. doi: 10.1093/rheumatology/kex260.
Yu C, Gershwin ME, Chang C. Diagnostic criteria for systemic lupus erythematosus: a critical review. J Autoimmun. 2014 Feb-Mar;48-49:10-3. doi: 10.1016/j.jaut.2014.01.004. Epub 2014 Jan 21.
Read RW. Clinical mini-review: systemic lupus erythematosus and the eye. Ocul Immunol Inflamm. 2004 Jun;12(2):87-99. doi: 10.1080/09273940490895308.
Benitez del Castillo JM, Wasfy MA, Fernandez C, Garcia-Sanchez J. An in vivo confocal masked study on corneal epithelium and subbasal nerves in patients with dry eye. Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3030-5. doi: 10.1167/iovs.04-0251.
Kanellopoulos AJ, Aslanides IM, Asimellis G. Correlation between epithelial thickness in normal corneas, untreated ectatic corneas, and ectatic corneas previously treated with CXL; is overall epithelial thickness a very early ectasia prognostic factor? Clin Ophthalmol. 2012;6:789-800. doi: 10.2147/OPTH.S31524. Epub 2012 May 23.
Nguyen P, Huang D, Li Y, Sadda SR, Ramos S, Pappuru RR, Yiu SC. Correlation between optical coherence tomography-derived assessments of lower tear meniscus parameters and clinical features of dry eye disease. Cornea. 2012 Jun;31(6):680-5. doi: 10.1097/ICO.0b013e3182261577.
Li Y, Tan O, Brass R, Weiss JL, Huang D. Corneal epithelial thickness mapping by Fourier-domain optical coherence tomography in normal and keratoconic eyes. Ophthalmology. 2012 Dec;119(12):2425-33. doi: 10.1016/j.ophtha.2012.06.023. Epub 2012 Aug 20.
Other Identifiers
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AS-OCT in juvenile SLE
Identifier Type: -
Identifier Source: org_study_id
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