Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04873739
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Mohamed Farouk Sayed Othman Abelkader, 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 SLE patients and compared to healthy subjects of similar age and gender.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Diagnostic Test: Anterior Segment OCT

Detailed 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)

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Anterior Segment Optical Coherence Tomography Study of Cornea and Tear Film Parameters in Systemic Lupus Erythematous Patients
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
20 patients SLE with dry eye
Anterior segment OCT for SLE patients with dry eye
Diagnostic Test: Anterior Segment OCT
AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.

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

50 normal subjects as control group of similar age and gender
Anterior segment OCT for normal subjects
Diagnostic Test: Anterior Segment OCT
AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.




Primary Outcome Measures :
  1. 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 3 groups; SLE patients with dry eye, SLE patients without dry eye and normal subjects.

  2. Measurement of corneal structural changes [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of Minia Governorate diagnosed with SLE and healthy one
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873739


Locations
Layout table for location information
Egypt
Minia university hospital
Minya, Egypt
Sponsors and Collaborators
Minia University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Abdelkader, Doctor Minia University hospital
Study Director: Mohamed Salah, Doctor Minia University hospital
Study Director: Mohamed Hamid, Doctor Minia University hospital
Publications:

Layout table for additonal information
Responsible Party: Mohamed Farouk Sayed Othman Abelkader, Principal Investigator, Minia University
ClinicalTrials.gov Identifier: NCT04873739    
Other Study ID Numbers: Anterior segment OCT in SLE
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Farouk Sayed Othman Abelkader, Minia University:
anterior segment optical coherence tomography
tear film
dry eye
systemic lupus erythematous
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases