Nailfold Capillaroscopic Assessment in Pediatric Uveitis... | NCT06070935

Studies
Nailfold Capillaroscopic Assessment in Pediatric Uveitis Patients

NCT06070935

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Uveitis

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

Oct 1, 2023

First Submission Date that Met QC Criteria

Oct 1, 2023

First Posted Date

Oct 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2024

Last Update Posted Date

Aug 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pediatric uveitis		pediatric uveitis patients < 18 years old
healthy subjects		healthy subjects< 18 years old

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
capillary density by nailfold capillaroscopy	(number of capillaries per mm)	6 months
detection of number of dilated capillaries by nailfold capillaroscopy	number of dilated capillaries (apex of >20µm)	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	6 months

Secondary Outcomes

Measure	Description	Time Frame
correlation of nailfold findings with uveitis activity	correlation of capillary abnormalities detected with active uveitis.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with uveitis < 18 years old

Exclusion Criteria:

infectious uveitis
age > 18 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric uveitis patients and healthy pediatric control

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maha Abdelrahman, MD, PHD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maha Abdelrahman		Asyut		71515	Egypt

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases