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

NCT04873739 | Completed

• 1 other identifier: Anterior segment OCT in SLE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

anterior segment optical coherence tomography; tear film; dry eye; systemic lupus erythematous

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

20 patients SLE with dry eye

Anterior segment OCT for SLE patients with dry eye

Diagnostic Test: Anterior Segment OCT

30 patients SLE without dry eye

Anterior segment OCT for SLE patients without dry eye

Diagnostic Test: Anterior Segment OCT

50 normal subjects as control group of similar age and gender

Anterior segment OCT for normal subjects

Diagnostic Test: Anterior Segment OCT

Interventions

Anterior Segment OCT DIAGNOSTIC_TEST

AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.

20 patients SLE with dry eye; 30 patients SLE without dry eye; 50 normal subjects as control group of similar age and gender

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Minia Governorate diagnosed with SLE and healthy one

You may qualify if:

• Age ≥18 years old..
• Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination

You may not qualify if:

• \. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.
• \. 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.
• \. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia university hospital

Minya, Egypt

Location

Related Publications (8)

• 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.

  PMID: 22811887 BACKGROUND

• 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.

  PMID: 28968809 BACKGROUND

• 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.

  PMID: 24461385 BACKGROUND

• Read RW. Clinical mini-review: systemic lupus erythematosus and the eye. Ocul Immunol Inflamm. 2004 Jun;12(2):87-99. doi: 10.1080/09273940490895308.

  PMID: 15512979 BACKGROUND

• 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.

  PMID: 15326117 BACKGROUND

• 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.

  PMID: 22701079 BACKGROUND

• 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.

  PMID: 22378111 BACKGROUND

• 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.

  PMID: 22917888 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Mohamed Abdelkader, Doctor

  Minia University Hospital

  PRINCIPAL INVESTIGATOR

• Mohamed Salah, Doctor

  Minia University Hospital

  STUDY DIRECTOR

• Mohamed Hamid, Doctor

  Minia University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: July 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 30, 2021
• Last Updated: February 3, 2022

Record last verified: 2021-06

Locations

EG (1)