Ocular Findings in Women With Primary Antiphospholipid Syndrome

Completed

• Conditions: Primary Antiphospholipid Syndrome
• Interventions: Diagnostic Test: Ophthalmological examination

• Registration Number: NCT03459508
• Lead Sponsor: Cairo University

Brief Summary

Antiphospholipid antibody syndrome (APS) is an autoimmune disease characterized by systemic thrombosis and bad obstetric history. APS secondary to another medical disorder is the most common. Visual and ocular changes e.g. vaso-occlusive disease of retinal and choroidal vessels are found in patients with secondary APS. Patients with primary APS have also been reported to have ocular changes e.g. retinal vascular occlusion

The aim of our study to detect prevalence of ocular changes in women diagnosed with primary APS and correlation of these changes with adverse obstetric outcome. If a correlation is present, ocular findings in women with APS could be used in the future as a predictor for poor obstetric outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-09
• Status Verified: 2018-10
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-23
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Age: 18 to 35 years
• Females with primary antiphospholipid syndrome

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Exclusion Criteria

• Age: below 18 years and above 35 years
• Auto-immune diseases e.g. SLE and other connective tissue disease
• Medical diseases causing retinal vascular changes e.g. hypertension, diabetes mellitus, sickle cell anemia.
• Previous vitreo-retinal surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary antiphospholipid syndrome women	Ophthalmological examination	1. Informed consent 2. Detailed history emphasizing on a. obstetric complications related to antiphospholipid syndrome: i. Recurrent miscarriage ii. Fetal demise iii. Fetal growth restriction iv. Severe pre-eclampsia or eclampsia v. Placental insufficiency vi. Placental abruption b. Systemic vascular complications related to antiphospholipid syndrome: i. Arterial thrombosis ii. Venous thrombosis iii. Small-vessel thrombosis 3. Revision of diagnosis of primary antiphospholipid syndrome: 4. Exclusion of antiphospholipid syndrome secondary to SLE and other autoimmune diseases by: antinuclear (ANA), anti-Smith (Sm) and anti-double stranded DNA (dsDNA) antibodies. 5. Ophthalmological examination:

Primary Outcome Measures

Name	Time	Method
The incidence of Ocular changes in females with antiphospholipid syndrome	On the same day of enrollment into the study	Number of participants with ocular findings detected by ophthalmological examination

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt