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

NCT05015465 | Unknown

• 1 other identifier: AS-OCT in juvenile SLE
• Study Type: observational
• Target: 140
• 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 juvenile SLE patients and compared to healthy subjects of similar age and gender.

Conditions

Juvenile Systemic Lupus Erythematosus

Keywords

anterior segment optical coherence tomography; tear film; dry eye; Juvenile 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 2 groups; juvenile SLE patients 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 2 groups; juvenile SLE patients and normal subjects.

  3 months

Study Arms (2)

70 patients with juvenile SLE.

Anterior segment OCT for juvenile SLE patients.

Diagnostic Test: Anterior Segment OCT

70 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 juvenile SLE patients and compare them with normal subjects

70 normal subjects as control group of similar age and gender; 70 patients with juvenile SLE.

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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 juvenile 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

RECRUITING

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

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Mohamed Salah, MD

  Minia University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Salah, MD

CONTACT

01003321802; Mohamedzaki@mu.edu.eg

Asmaa Anwar, MD

CONTACT

01006048882; Asmaa.anwar@mu.edu.eg

Study Design

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

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: July 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

EG (1)