Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04866615
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-04-13
Brief Title:
Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Posterior Segment Evaluation of Patients With Systemic Lupus Erythematosus Using Optical Coherence Tomography and Optical Coherence Tomography Angiography
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
siccaKCS 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 hydroxychloroquineHCQ a cornerstone in lupus treatment rarely causes ocular toxicity at doses of less than 65 mgkg 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 bulls-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
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
siccaKCS 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 hydroxychloroquineHCQ a cornerstone in lupus treatment rarely causes ocular toxicity at doses of less than 65 mgkg 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 bulls-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None