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

• Conditions: Juvenile Systemic Lupus Erythematosus
• Interventions: Diagnostic Test: Anterior Segment OCT

• Registration Number: NCT05015465
• Lead Sponsor: Minia University

Brief Summary

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 juvenile SLE patients and compared to healthy subjects of similar age and gender.

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 Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20
• Primary Completion: 2021-10-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

  3. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
70 patients with juvenile SLE.	Anterior Segment OCT	Anterior segment OCT for juvenile SLE patients.
70 normal subjects as control group of similar age and gender	Anterior Segment OCT	Anterior segment OCT for normal subjects

Primary Outcome Measures

Name	Time	Method
Measurement of Tear meniscus.	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.
Measurement of corneal structural changes	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.

Trial Locations

Locations (1)

Minia University Hospital; 🇪🇬 Minya, Egypt