CClinicalTrials.gg
CompletedNCT03459508Updated Oct 24, 2018

Ocular Findings in Women With Primary Antiphospholipid Syndrome

An observational study in Primary Antiphospholipid Syndrome, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-10-24.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Primary Antiphospholipid Syndrome

Keywords

  • Antiphospholipid Syndrome - Bad obstetric history - Ocular
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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)

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testOphthalmological 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.

    Also known as: slit lamp biomicroscopy, slit lamp exam

05

What researchers measure

Primary outcomes

  1. The incidence of Ocular changes in females with antiphospholipid syndrome

    Number of participants with ocular findings detected by ophthalmological examination

    Time frame: On the same day of enrollment into the study

06

Study locations

1 site
  • Cairo University
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03459508
Lead sponsor
Cairo University
Responsible party
Ahmed AA Wali, MD (Lecturer of Obstetrics and Gynecology, Cairo University) — Principal investigator
First posted
Mar 9, 2018
Start date
Dec 1, 2017
Primary completion
Oct 10, 2018
Completion
Oct 23, 2018
Last update
Oct 24, 2018

Study contacts

Ahmed AA Wali, MD
principal investigator · Cairo University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion