Ocular Findings in Women With Primary Antiphospholipid Syndrome

NCT03459508 | Completed

• 1 other identifier: N-2aa5-2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Antiphospholipid Syndrome

Keywords

Antiphospholipid Syndrome - Bad obstetric history - Ocular

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Primary antiphospholipid syndrome women

1. Informed consent 2. 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 3. Revision of diagnosis of primary antiphospholipid syndrome: 4. Exclusion of antiphospholipid syndrome secondary to SLE and other autoimmune diseases by: antinuclear (ANA), anti-Smith (Sm) and anti-double stranded DNA (dsDNA) antibodies. 5. Ophthalmological examination:

Diagnostic Test: Ophthalmological examination

Interventions

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.

Also known as: slit lamp biomicroscopy, slit lamp exam

Primary antiphospholipid syndrome women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age: 18 to 35 years
• Females with primary antiphospholipid syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Slit Lamp Microscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed AA Wali, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 9, 2018
• Study Start: December 1, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 23, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

EG (1)