Ocular Findings in Women With Primary Antiphospholipid Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Antiphospholipid Syndrome
• Intervention / Treatment: Diagnostic test: Ophthalmological examination

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients (inpatient or outpatient) with primary antiphospholipid syndrome at Kasr-Alainy hospital (The Cairo University Hospital)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Primary antiphospholipid syndrome women; Informed consent; Detailed history emphasizing ona. 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:

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.; Other Names: slit lamp biomicroscopy; slit lamp exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed AA Wali, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 23, 2018

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Antiphospholipid Syndrome - Bad obstetric history - Ocular
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Syndrome; Antiphospholipid Syndrome
• Other Study ID Numbers: N-2aa5-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided