Ocular Findings in Women With Primary Antiphospholipid Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Ocular Findings in Women With Primary Antiphospholipid Syndrome and Their Association to Bad Obstetric Outcome

Conditions
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Primary Antiphospholipid Syndrome

Intervention / Treatment
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* Diagnostic Test: Ophthalmological examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to 35 years Females with primary antiphospholipid syndrome 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary antiphospholipid syndrome women<br>Informed consent 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 Revision of diagnosis of primary antiphospholipid syndrome: Exclusion of antiphospholipid syndrome secondary to SLE and other autoimmune diseases by: antinuclear (ANA), anti-Smith (Sm) and anti-double stranded DNA (dsDNA) antibodies. Ophthalmological examination: | Diagnostic Test: Ophthalmological examination<br>* Detailed anterior segment examination using slit-lamp biomicroscopy for signs of anterior uveitis, and detailed fundus examination using slit-lamp fundus biomicroscopy with + 90 diopter lens searching for signs of vasculitis and posterior uveitis.<br>* Other names: slit lamp exam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Ocular changes in females with antiphospholipid syndrome | Number of participants with ocular findings detected by ophthalmological examination | On the same day of enrollment into the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiphospholipid Syndrome - Bad obstetric history - Ocular