Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06070935

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

May 15, 2024

Anticipated Study Completion Date :

Jul 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
pediatric uveitis pediatric uveitis patients < 18 years old
healthy subjects healthy subjects< 18 years old

Outcome Measures

Primary Outcome Measures

capillary density by nailfold capillaroscopy [6 months]
(number of capillaries per mm)
detection of number of dilated capillaries by nailfold capillaroscopy [6 months]
number of dilated capillaries (apex of >20µm)
detection of other abnormalities as avascular areas, microhemorrhages, and abnormal capillary morphology [6 months]
detection of multiple crossings, tortuous, bushy, ramified, non-convex, or bizarre capillaries

Secondary Outcome Measures

correlation of nailfold findings with uveitis activity [6 months]
correlation of capillary abnormalities detected with active uveitis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients with uveitis < 18 years old

Exclusion Criteria:

infectious uveitis
age > 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Assiut university hospital	Assiut		Egypt	71515
2	Maha Abdelrahman	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Maha Abdelrahman, MD, PHD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maha Sayed Ibrahim Abdelrahman, Principal invesigator, Assiut University

ClinicalTrials.gov Identifier:

NCT06070935

Other Study ID Numbers:

Nailfold capillaroscopy

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uveitis

Study Results

No Results Posted as of Oct 6, 2023