Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA

SLE (Systemic Lupus) Clinical Trial

Official title:

Posterior Segment Evaluation of Patients With Systemic Lupus Erythematosus Using Optical Coherence Tomography and Optical Coherence Tomography Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866615
• Other study ID #: OCT&OCTA in SLE
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: July 2021
• Source: Minia University
• Contact: Hazem Mohamed, Resident
• Phone: +201010045499
• Email: dr.hazemmohamed2013[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease that involves different organs and systems. The heterogeneous nature of the disease represents a great challenge in its diagnosis and management. Studies reported that the percentage of SLE patients demonstrating ocular manifestations can reach up to 30%. The pathogenesis of the ocular involvement is still unclear, but immune complex vasculopathy and inflammatory mediators might be implicated. The most common ocular manifestation in SLE was found to be kerato-conjunctivitis sicca(KCS) followed by retinopathy, where is the most severe manifestation was the optic nerve involvement, which might end up with irreversible blindness while anterior uveitis is a rare manifestation in SLE. Retinal involvement can vary from subclinical vascular changes to vaso- occlusive vision-threatening retinopathy. Lupus retinopathy is secondary to IgG complex-mediated micro-angiopathy that leads to small vessels infarcts. Currently, there is no agreement on existing biomarkers to identify SLE patients who have subclinical retinal involvement, or to identify whether micro-vascular changes in the retina are attributable to SLE. Lupus retinopathy is usually associated with high disease activity especially nephritis and cerebritis. On the other side, hydroxychloroquine,(HCQ) a cornerstone in lupus treatment, rarely causes ocular toxicity at doses of less than 6.5 mg/kg per day. Moreover, HCQ is found to be associated with retinopathy after a prolonged time of treatment (>5 years). HCQ binds to melanin pigments in the retinal pigment epithelium (RPE). This binding may serve to concentrate the agents in the cell and contribute to their long-term effects. The classic pattern of retinal toxicity of HCQ is RPE depigmentation with foveal sparing, known as bull's-eye maculopathy. Although visual acuity in these patients seems intact, patients complain from para-central scotomas associated with reading difficulties. Besides, reduced color perception can be seen as retinopathy symptoms. That is why it is important to evaluate the eyes before starting therapy and during follow-up visits. Modern imaging techniques have provided easier and more accurate evaluation as Optical coherence tomography (OCT) is a noninvasive imaging technology, which picks up cross-sectional pictures of the retinal layers, detect thinning of retinal nerve fiber layer and macula. Optical coherence tomography angiography (OCTA) is a relatively new technique that allows visualization of the retina capillary bed and its subtle changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2021
• Est. primary completion date: October 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 and anti-glaucoma surgery.

2. Patients with significant media opacity as corneal opacity, cataract.

3. Patients with ocular diseases as glaucoma, uveitis.

4. Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.

5. Patients with systemic diseases as diabetes mellitus (DM), hypertension, abnormal kidney functions

Related Conditions & MeSH terms

• SLE (Systemic Lupus)

Intervention

Diagnostic Test:
• Optvue OCT
Optical coherence tomography

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 (7)

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. — View Citation

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. — View Citation

Kahwage PP, Ferriani MP, Furtado JM, de Carvalho LM, Pileggi GS, Gomes FH, Terreri MT, Magalhães CS, Pereira RM, Sacchetti SB, Marini R, Bonfá 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. — View Citation

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. Epub 2016 Jul 8. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Sivaraj RR, Durrani OM, Denniston AK, Murray PI, Gordon C. Ocular manifestations of systemic lupus erythematosus. Rheumatology (Oxford). 2007 Dec;46(12):1757-62. Epub 2007 Aug 5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measurement of foveal avascular zone	1) comparison of foveal avascular zone between 3 groups using OCT Angiography.	3 months
Primary	Measurement of macular thickness	comparison of macular thickness between 3 groups using OCT.	3 months
Primary	Measurement thickness of retinal nerve fiber layer	Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.	3 months
Primary	Measurement of thickness of ganglion cell layer complex	Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.	3 months