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OpenTrials
Completed

NCT Number: NCT03459508

Ocular Findings in Women With Primary Antiphospholipid Syndrome

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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Key information

Conditions

Primary Antiphospholipid Syndrome

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ophthalmological examination

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.

Other names: slit lamp biomicroscopy, slit lamp exam

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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