Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA

NCT04866615 | Unknown

• 1 other identifier: OCT&OCTA in SLE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of The Study To evaluate different structural retinal changes using OCT and OCT-A in patients with SLE ; newly diagnosed patients and patients on treatment and compare parameters with normal subjects

Conditions

SLE (Systemic Lupus)

Outcome Measures

Primary Outcomes (5)

• Measurement of vessel density

  comparison of vessel density of superficial and deep layers of retina in 150 subjects divided into 3 groups newly diagnosed SLE patients and SLE patients on treatment and normal subjects using OCT Angiography.

  3 months

• Measurement of foveal avascular zone

  1\) comparison of foveal avascular zone between 3 groups using OCT Angiography.

  3 months

• Measurement of macular thickness

  comparison of macular thickness between 3 groups using OCT.

  3 months

• Measurement thickness of retinal nerve fiber layer

  Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.

  3 months

• Measurement of thickness of ganglion cell layer complex

  Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.

  3 months

Study Arms (3)

50 patients newly diagnosed SLE with no treatment

OCT \& OCTA for newly diagnosed SLE patients

Diagnostic Test: Optvue OCT

50 patients SLE on treatment by (HCQ) at doses of less than 6.5 mg/kg per day for less than 5 years

OCT \& OCTA for on treatment SLE patients

Diagnostic Test: Optvue OCT

50 normal subjects as control group of similar age and gender

OCT \& OCTA for normal subjects

Diagnostic Test: Optvue OCT

Interventions

Optvue OCT DIAGNOSTIC_TEST

Optical coherence tomography

50 normal subjects as control group of similar age and gender; 50 patients SLE on treatment by (HCQ) at doses of less than 6.5 mg/kg per day for less than 5 years; 50 patients newly diagnosed SLE with no treatment

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 and anti-glaucoma surgery.
• Patients with significant media opacity as corneal opacity, cataract.
• Patients with ocular diseases as glaucoma, uveitis.
• 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 (DM), hypertension, abnormal kidney functions

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia university hospital

Minya, Egypt

RECRUITING

Related Publications (7)

• Larosa M, Iaccarino L, Gatto M, Punzi L, Doria A. Advances in the diagnosis and classification of systemic lupus erythematosus. Expert Rev Clin Immunol. 2016 Dec;12(12):1309-1320. doi: 10.1080/1744666X.2016.1206470. Epub 2016 Jul 8.

  PMID: 27362864 BACKGROUND

• Shoughy SS, Tabbara KF. Ocular findings in systemic lupus erythematosus. Saudi J Ophthalmol. 2016 Apr-Jun;30(2):117-21. doi: 10.1016/j.sjopt.2016.02.001. Epub 2016 Feb 16.

  PMID: 27330388 BACKGROUND

• El-Shereef RR, Mohamed AS, Hamdy L. Ocular manifestation of systemic lupus erythematosus. Rheumatol Int. 2013 Jun;33(6):1637-42. doi: 10.1007/s00296-011-2296-x. Epub 2011 Dec 28.

  PMID: 22202921 BACKGROUND

• Kahwage PP, Ferriani MP, Furtado JM, de Carvalho LM, Pileggi GS, Gomes FH, Terreri MT, Magalhaes CS, Pereira RM, Sacchetti SB, Marini R, Bonfa E, Silva CA, Ferriani VP. Uveitis in childhood-onset systemic lupus erythematosus patients: a multicenter survey. Clin Rheumatol. 2017 Mar;36(3):547-553. doi: 10.1007/s10067-016-3534-0. Epub 2017 Jan 9.

  PMID: 28070763 BACKGROUND

• Sivaraj RR, Durrani OM, Denniston AK, Murray PI, Gordon C. Ocular manifestations of systemic lupus erythematosus. Rheumatology (Oxford). 2007 Dec;46(12):1757-62. doi: 10.1093/rheumatology/kem173. Epub 2007 Aug 5.

  PMID: 17681981 BACKGROUND

• Farrell DF. Retinal toxicity to antimalarial drugs: chloroquine and hydroxychloroquine: a neurophysiologic study. Clin Ophthalmol. 2012;6:377-83. doi: 10.2147/OPTH.S27731. Epub 2012 Mar 8.

  PMID: 22457587 BACKGROUND

• Marmor MF, Kellner U, Lai TY, Melles RB, Mieler WF; American Academy of Ophthalmology. Recommendations on Screening for Chloroquine and Hydroxychloroquine Retinopathy (2016 Revision). Ophthalmology. 2016 Jun;123(6):1386-94. doi: 10.1016/j.ophtha.2016.01.058. Epub 2016 Mar 16.

  PMID: 26992838 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Azza Shehab, MD

  Minia University Hospital

  STUDY DIRECTOR

• Mohamed Farouk, MD

  Minia University Hospital

  STUDY DIRECTOR

• Mohamed Salah, MD

  Minia University Hospital

  STUDY DIRECTOR

• Hazem Mohamed, Resident

  Minia University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem Mohamed, Resident

CONTACT

+201010045499; dr.hazemmohamed2013@gmail.com

Mohamed Salah, MD

CONTACT

01003321802; drmsalah1982@yahoo.com

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: April 13, 2021
• First Posted: April 30, 2021
• Study Start: June 4, 2021
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

EG (1)