Primary Antiphospholipid SyndromeNCT03459508
Ocular Findings in Women With Primary Antiphospholipid Syndrome
An observational study of Primary Antiphospholipid Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Antiphospholipid Syndrome
- What is being tested?
- Ophthalmological examination
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 23 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients (inpatient or outpatient) with primary antiphospholipid syndrome at Kasr-Alainy hospital (The Cairo University Hospital)
Who may be able to join
- Age: 18 to 35 years
- Females with primary antiphospholipid syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Primary Antiphospholipid Syndrome
- Being tested
- Ophthalmological examination
- Keywords
- Antiphospholipid Syndrome - Bad obstetric history - Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmological examinationDiagnostic test
Also called slit lamp biomicroscopy, slit lamp exam
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.
| Study group | Role | What they receive |
|---|---|---|
| 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: Receives: Diagnostic Test: Ophthalmological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Ocular changes in females with antiphospholipid syndrome
Number of participants with ocular findings detected by ophthalmological examination
Measured: On the same day of enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Dec 2017
- Primary completion10 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed AA Wali, MD, Cairo University
- Investigators
- Ahmed AA Wali, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459508
- Sponsor's protocol ID
- N-2aa5-2018
- Status last verified
- Oct 2018
- First submitted
- 22 Feb 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Findings in Women With Primary Antiphospholipid Syndrome and Their Association to Bad Obstetric Outcome
- ClinicalTrials.gov ID
- NCT03459508
- Acronym / sponsor ID
- N-2aa5-2018
- Conditions
- Primary Antiphospholipid Syndrome
- Keywords
- Antiphospholipid Syndrome - Bad obstetric history - Ocular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary antiphospholipid syndrome women | – | Diagnostic Test: Ophthalmological examination1. 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: |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients (inpatient or outpatient) with primary antiphospholipid syndrome at Kasr-Alainy hospital (The Cairo University Hospital)
Key inclusion criteria (2 listed)
- Age: 18 to 35 years
- Females with primary antiphospholipid syndrome
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmological examinationAlso: slit lamp biomicroscopy, slit lamp examDetailed 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. | Diagnostic test | Primary antiphospholipid syndrome women |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed AA Wali, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Antiphospholipid Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Ocular changes in females with antiphospholipid syndrome (time frame: On the same day of enrollment into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.