Ocular Findings in Women With Primary Antiphospholipid Syndrome

• ClinicalTrials.gov Identifier: NCT03459508
• Recruitment Status: Completed
• First Posted: March 9, 2018
• Last Update Posted: October 24, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed AA Wali, MD, Cairo University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Primary Antiphospholipid Syndrome	Diagnostic Test: Ophthalmological examination

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Ocular Findings in Women With Primary Antiphospholipid Syndrome and Their Association to Bad Obstetric Outcome
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: October 10, 2018
• Actual Study Completion Date: October 23, 2018

Groups and Cohorts

Group/Cohort

Intervention/treatment

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:

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Egypt

Cairo University

Cairo, Egypt

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Ahmed AA Wali, MD; Cairo University

More Information

• Responsible Party: Ahmed AA Wali, MD, Lecturer of Obstetrics and Gynecology, Cairo University
• ClinicalTrials.gov Identifier: NCT03459508
• Other Study ID Numbers: N-2aa5-2018
• First Posted: March 9, 2018
• Last Update Posted: October 24, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Ahmed AA Wali, MD, Cairo University:

Antiphospholipid Syndrome - Bad obstetric history - Ocular

Additional relevant MeSH terms:

Antiphospholipid Syndrome; Syndrome; Disease; Pathologic Processes; Autoimmune Diseases; Immune System Diseases