Ocular Findings in Women With Primary Antiphospholipid Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-10-23

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.

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Detailed Description

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Conditions

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Primary Antiphospholipid Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Primary antiphospholipid syndrome women

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:

Ophthalmological examination

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Ophthalmological examination

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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slit lamp biomicroscopy slit lamp exam

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No