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Ocular Findings in Women With Primary Antiphospholipid Syndrome

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Primary Antiphospholipid Syndrome

Treatments

Diagnostic Test: Ophthalmological examination

Study type

Observational

Funder types

Other

Identifiers

NCT03459508
N-2aa5-2018

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Primary antiphospholipid syndrome women
Description:
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:
Treatment:
Diagnostic Test: Ophthalmological examination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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