Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 50 patients newly diagnosed SLE with no treatment OCT & OCTA for newly diagnosed SLE patients |
Diagnostic Test: Optvue OCT
Optical coherence tomography
|
| 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
Optical coherence tomography
|
| 50 normal subjects as control group of similar age and gender OCT & OCTA for normal subjects |
Diagnostic Test: Optvue OCT
Optical coherence tomography
|
Outcome Measures
Primary Outcome Measures
- Measurement of vessel density [3 months]
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.
- Measurement of foveal avascular zone [3 months]
1) comparison of foveal avascular zone between 3 groups using OCT Angiography.
- Measurement of macular thickness [3 months]
comparison of macular thickness between 3 groups using OCT.
- Measurement thickness of retinal nerve fiber layer [3 months]
Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
- Measurement of thickness of ganglion cell layer complex [3 months]
Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years old.
-
Patients with SLE diagnosed by a Rheumatologist with no ocular involvement upon clinical examination
Exclusion Criteria:
-
Patients with history of intraocular surgery as cataract surgery retinal detachment surgery and anti-glaucoma surgery.
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Patients with significant media opacity as corneal opacity, cataract.
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Patients with ocular diseases as glaucoma, uveitis.
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Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
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Patients with systemic diseases as diabetes mellitus (DM), hypertension, abnormal kidney functions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Minia university hospital | Minya | Egypt |
Sponsors and Collaborators
- Minia University
Investigators
- Study Director: Azza Shehab, MD, Minia University hospital
- Study Director: Mohamed Farouk, MD, Minia University hospital
- Study Director: Mohamed Salah, MD, Minia University hospital
- Principal Investigator: Hazem Mohamed, Resident, Minia University hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- OCT&OCTA in SLE