Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA

July 5, 2021 updated by: Hazem Mohamed Mohamed, Minia University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of Minia Governorate diagnosed with SLE and healthy one

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of vessel density
Time Frame: 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.
3 months
Measurement of foveal avascular zone
Time Frame: 3 months
1) comparison of foveal avascular zone between 3 groups using OCT Angiography.
3 months
Measurement of macular thickness
Time Frame: 3 months
comparison of macular thickness between 3 groups using OCT.
3 months
Measurement thickness of retinal nerve fiber layer
Time Frame: 3 months
Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
3 months
Measurement of thickness of ganglion cell layer complex
Time Frame: 3 months
Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • OCT&OCTA in SLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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