ClinicalTrials.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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Antiphospholipid Syndrome with a site in Egypt — 5 open to participants now, 5 under way, none of them phase 3. Antiphospholipid Syndrome · Egypt.

Started
2017
the only one that year
Observational
4 of 10
2 open now
Registered
4th of 10
by date
Lead sponsor
2 of 10
Cairo University

Among the 10 studies in Antiphospholipid Syndrome with a site in Egypt, this one is the only one that started in 2017, is one of 4 observational ones, and was the 4th registered.

Antiphospholipid Syndrome

121 studies on the registry are indexed under Antiphospholipid Syndrome; 52 are open to participants now.

Browse Antiphospholipid Syndrome studies →

Open to participants now

5 of the 10 studies in Antiphospholipid Syndrome with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 38 Antiphospholipid Syndrome studies recruiting now, 14 (37%) set no upper age limit and 19 (50%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.

This study: 18 Years to 35 Years · female · no healthy volunteers.

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02

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.

03

Conditions studied

  • Primary Antiphospholipid Syndrome

Keywords

  • Antiphospholipid Syndrome - Bad obstetric history - Ocular
04

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Oct 2018, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2018
First posted
Mar 9, 2018
StartActual
Dec 1, 2017
Primary completionActual
Oct 10, 2018
CompletionActual
Oct 23, 2018
Last update
Oct 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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