Ocular Findings in Women With Primary Antiphospholipid Syndrome

Overview

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.

Full Title of Study: “Ocular Findings in Women With Primary Antiphospholipid Syndrome and Their Association to Bad Obstetric Outcome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 10, 2018

Interventions

  • Diagnostic Test: 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.

Arms, Groups and Cohorts

  • Primary antiphospholipid syndrome women
    • 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:

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed AA Wali, MD, Lecturer of Obstetrics and Gynecology – Cairo University
  • Overall Official(s)
    • Ahmed AA Wali, MD, Principal Investigator, Cairo University

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