Ocular Findings in Women With Primary Antiphospholipid Syndrome

Primary Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459508
• Other study ID #: N-2aa5-2018
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: October 23, 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 23, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Primary Antiphospholipid Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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