UveitisNCT06070935
Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients
An observational study of Uveitis, run by Assiut University at 1 site in Egypt.
Trial summary
Pediatric uveitis accounts for 5-10% of uveitis cases. it may be infectious or noninfectious in etiology. The etiology of noninfectious uveitis may be autoimmune. The most common causes of pediatric uveitis are idiopathic and juvenile idiopathic arthritis-associated uveitis. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: pediatric uveitis patients and healthy pediatric control
Who may be able to join
- patients with uveitis < 18 years old
Who cannot join
- infectious uveitis
- age > 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Pediatric uveitis accounts for 5-10% of uveitis cases. it may be infectious or noninfectious in etiology. The etiology of noninfectious uveitis may be autoimmune. The most common causes of pediatric uveitis are idiopathic and juvenile idiopathic arthritis-associated uveitis. Uveitis morbidities in pediatric patients include cataract, glaucoma, and amblyopia. Pediatric uveitis may be accopanied by involvement of the ocular vasculature, such as retinal vasculitis. We hypothesize that there are differences in systemic microcirculation between pediatric uveitis patients and healthy pediatric controls.
Read the detailed description
The systemic microcirculation will be investigated through nailfold capillaroscopic (NFC) assessment with noninfectious uveitis and healthy pediatric controls.
The NFC parameters are:
capillary density (number of capillaries per mm), dilated capillaries (apex of >20µm), avascular areas, the presence of microhemorrhages, and capillary morphology (normal, multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries).
- Conditions
- Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pediatric uveitis | pediatric uveitis patients < 18 years old | |
| healthy subjects | healthy subjects< 18 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
capillary density by nailfold capillaroscopy
(number of capillaries per mm)
Measured: 6 months
detection of number of dilated capillaries by nailfold capillaroscopy
number of dilated capillaries (apex of >20µm)
Measured: 6 months
detection of other abnormalities as avascular areas, microhemorrhages, and abnormal capillary morphology
detection of multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries
Measured: 6 months
Secondary outcomes (1)
correlation of nailfold findings with uveitis activity
correlation of capillary abnormalities detected with active uveitis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jan 2024
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Sayed Ibrahim Abdelrahman, Assiut University
- Investigators
- Maha Abdelrahman, MD, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070935
- Sponsor's protocol ID
- Nailfold capillaroscopy
- Status last verified
- Aug 2024
- First submitted
- 1 Oct 2023
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients
- ClinicalTrials.gov ID
- NCT06070935
- Acronym / sponsor ID
- Nailfold capillaroscopy
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Oct 2023 (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.
Pediatric uveitis accounts for 5-10% of uveitis cases. it may be infectious or noninfectious in etiology. The etiology of noninfectious uveitis may be autoimmune. The most common causes of pediatric uveitis are idiopathic and juvenile idiopathic arthritis-associated uveitis. Uveitis morbidities in pediatric patients include cataract, glaucoma, and amblyopia. Pediatric uveitis may be accopanied by involvement of the ocular vasculature, such as retinal vasculitis. We hypothesize that there are differences in systemic microcirculation between pediatric uveitis patients and healthy pediatric controls.
Detailed description
The systemic microcirculation will be investigated through nailfold capillaroscopic (NFC) assessment with noninfectious uveitis and healthy pediatric controls.
The NFC parameters are:
capillary density (number of capillaries per mm), dilated capillaries (apex of >20µm), avascular areas, the presence of microhemorrhages, and capillary morphology (normal, multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric uveitis | – | –pediatric uveitis patients < 18 years old |
| healthy subjects | – | –healthy subjects< 18 years old |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pediatric uveitis patients and healthy pediatric control
Key inclusion criteria (1 listed)
- patients with uveitis < 18 years old
Key exclusion criteria (2 listed)
- infectious uveitis
- age > 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
capillary density by nailfold capillaroscopy
Time frame: 6 months
(number of capillaries per mm)
detection of number of dilated capillaries by nailfold capillaroscopy
Time frame: 6 months
number of dilated capillaries (apex of >20µm)
detection of other abnormalities as avascular areas, microhemorrhages, and abnormal capillary morphology
Time frame: 6 months
detection of multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries
1 secondary outcome
correlation of nailfold findings with uveitis activity
Time frame: 6 months
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 15 Aug 2024.
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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.
Maha Abdelrahman, MD, PHD principal investigator
Assiut 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 Uveitis, run by Assiut 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 1 inclusion and 2 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 15 Aug 2024. 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?
capillary density by nailfold capillaroscopy (time frame: 6 months). The study lists 3 primary outcomes in all. 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 15 Aug 2024.