Multifocal Electro Retinogram Study of Hydroxy Chloroquine Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial."
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Analysis of values of R1 or R2 amplitude or Ring Ratio
Study Overview
Brief Summary
The aim of the study to assess the multifocal ERG (mfERG) changes in SLE patients treated with chloroquine in renal patients with comparison to SLE patients without kidney affection.
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.1 Studies
reported that the percentage of SLE patients demonstrating ocular manifestations
can reach up to 30%.2
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years old.
- •Emmetropic patients with normal fundus.
- •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, anti-glucoma surgery.
- •Patients with significant media opacity as corneal opacity, cataract.
- •Patients with ocular diseases as glaucoma, uveitis.
- •Patients with systemic diseases as diabetes mellitus, hypertension.
Outcomes
Primary Outcomes
Analysis of values of R1 or R2 amplitude or Ring Ratio
Time Frame: 3 months
Abnormal values of R1 or R2 amplitude or Ring Ratio (R1 / R2, R1 / R3, R1 / R4, R1 / R5) in each of the patient's eyes as abnormal mfERG.
Analysis of mfERG parameters
Time Frame: 3 months
Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Salah
Doctor
Minia University