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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 patients newly diagnosed SLE with no treatment | OCT & OCTA for newly diagnosed SLE patients |
| |
| 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 |
| |
| 50 normal subjects as control group of similar age and gender | OCT & OCTA for normal subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optvue OCT | Diagnostic Test | Optical coherence tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Residents of Minia Governorate diagnosed with SLE and healthy one
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hazem Mohamed, Resident | Contact | +201010045499 | dr.hazemmohamed2013@gmail.com | |
| Mohamed Salah, MD | Contact | 01003321802 | drmsalah1982@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Azza Shehab, MD | Minia University Hospital | Study Director |
| Mohamed Farouk, MD | Minia University Hospital | Study Director |
| Mohamed Salah, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia university hospital | Recruiting | Minya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27362864 | Background | 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. | |
| 27330388 | 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. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Minia University Hospital |
| Study Director |
| Hazem Mohamed, Resident | Minia University Hospital | Principal Investigator |
| 22202921 | 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. |
| 28070763 | 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. |
| 17681981 | 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. |
| 22457587 | 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. |
| 26992838 | 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. |