- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05015465
AS-OCT Study of Cornea and Tear Film Parameters in Juvenile SLE Patients
Anterior Segment Optical Coherence Tomography of Cornea in Patients With Child Onset Systemic Lupus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Juvenile 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 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)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mohamed Salah, MD
- Phone Number: 01003321802
- Email: Mohamedzaki@mu.edu.eg
Study Contact Backup
- Name: Asmaa Anwar, MD
- Phone Number: 01006048882
- Email: Asmaa.anwar@mu.edu.eg
Study Locations
-
-
-
Minya, Egypt
- Recruiting
- Minia University Hospital
-
Contact:
- Mohamed Salah, MD
- Phone Number: 01003321802
- Email: Mohamedzaki@mu.edu.eg
-
Contact:
- Asmaa Anwar, MD
- Phone Number: 01006048882
- Email: Asmaa.anwar@mu.edu.eg
-
Principal Investigator:
- Mohamed Salah, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≤18 years old. Patients with juvenile 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
70 patients with juvenile SLE.
Anterior segment OCT for juvenile SLE patients.
|
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
|
AS-OCT for juvenile SLE patients and compare them with normal subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Tear meniscus.
Time Frame: 3 months
|
to measure lower tear meniscus height and area and depth with AS-OCT and comparing results between 2 groups; juvenile SLE patients and normal subjects.
|
3 months
|
Measurement of corneal structural changes
Time Frame: 3 months
|
To measure corneal Thickness, epithelial thickness and stromal thickness using AS-OCT comparing results between 2 groups; juvenile SLE patients and normal subjects.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Salah, MD, Minia University Hospital
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS-OCT in juvenile SLE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Systemic Lupus Erythematosus
-
University of Sao PauloUnknownJuvenile Dermatomyositis | Juvenile Systemic Lupus ErythematosusBrazil
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompletedSystemic Lupus Erythematosus (SLE) | Cutaneous Lupus | Juvenile SLEBrazil
-
Children's National Research InstituteRecruitingSystemic Lupus Erythematosus | Fibromyalgia | Juvenile Idiopathic ArthritisUnited States
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
N.M. WulffraatNational Institute for Public Health and the Environment (RIVM)CompletedSystemic Lupus Erythematosus | Juvenile Idiopathic Arthritis | Juvenile DermatomyositisNetherlands
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingSystemic Lupus Erythematosus, SLEChina
-
TJ Biopharma Co., Ltd.TerminatedSystemic Lupus Erythematosus (SLE)China
Clinical Trials on Anterior Segment OCT
-
Minia UniversityCompleted
-
Duke UniversityTerminatedPrimary Open Angle Glaucoma | Cataracts | Exfoliation SyndromeUnited States
-
Assiut UniversityNot yet recruitingCorneal Ectasia of Both Eyes
-
Minia UniversityUnknown
-
Tomey CorporationCompletedGlaucoma | CataractUnited States
-
Tomey CorporationCompletedEvaluate the Agreement and Precision of Device SS-1000 and the Predicate Device the Pentacam in a Reproducibility and Repeatability TrialJapan
-
University of Texas Southwestern Medical CenterCompletedCorneal Edema Secondary to Corneal Endothelial DystrophyUnited States
-
Northwestern UniversityTerminatedGlaucoma | Glaucoma Following SurgeryUnited States
-
Assiut UniversityUnknownFemtosecond Laser in Comparison to Moria Microkeratome in Creating Corneal Flaps