Skip to content

Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04866615
Enrollment
150
Registered
2021-04-30
Start date
2021-06-04
Completion date
2021-11-01
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE (Systemic Lupus)

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 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.

Interventions

DIAGNOSTIC_TESTOptvue OCT

Optical coherence tomography

Sponsors

Minia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of vessel density3 monthscomparison 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 zone3 months1\) comparison of foveal avascular zone between 3 groups using OCT Angiography.
Measurement of macular thickness3 monthscomparison of macular thickness between 3 groups using OCT.
Measurement thickness of retinal nerve fiber layer3 monthsComparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
Measurement of thickness of ganglion cell layer complex3 monthsComparison of thickness of ganglion cell layer complex between the 3 groups using OCT.

Countries

Egypt

Contacts

Primary ContactHazem Mohamed, Resident
dr.hazemmohamed2013@gmail.com+201010045499
Backup ContactMohamed Salah, MD
drmsalah1982@yahoo.com01003321802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026