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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873739
• Other study ID #: Anterior segment OCT in SLE
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2021
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 30, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age =18 years old..

2. 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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Anterior Segment OCT
AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.

Locations

Country	Name	City	State
Egypt	Minia university hospital	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Benítez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Read RW. Clinical mini-review: systemic lupus erythematosus and the eye. Ocul Immunol Inflamm. 2004 Jun;12(2):87-99. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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