Incidence of Ocular Antibodies in Patients With Sturge -... | NCT00610402

Studies
Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)

NCT00610402

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Oct 20, 2022Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Sturge - Weber Syndrome (SWS)

Interventions

blood sample tear drop sample

Countries

United States

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

Oct 2022

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

Jul 2007

Primary Completion Date

Jul 2007Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 25, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Feb 8, 2008Estimated

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

Oct 19, 2022

Last Update Posted Date

Oct 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Mainz University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life.

Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field. Recently, several studies provided evidence that there is a potential role of the immune system in the pathogenesis of glaucoma.

These findings suggest that there might be changes in systemic humoral immunity possibly underlying the optic neuropathy in at least some glaucoma patients.

Detailed Description

The ocular antibody profile in patients with SWS is unknown.The researchers want to study on blood and tear drop samples from patients with SWS to determine the incidence of ocular antibodies in patients with this syndrome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood sample tear drop sample		blood sample tear drop sample	Other: blood sample tear drop sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample tear drop sample	Other	blood sample tear drop sample	blood sample tear drop sample

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female volunteers with SWS of all ages

Exclusion Criteria:

Volunteers without SWS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

community sample

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John S Nelson, M.D,PhD	Beckman Laser Institute University of California Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute Medical clinic		Irvine	California	92612	United States

Condition Browse Module

MeSH Terms

ID	Term
D020526	Brain Stem Infarctions

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

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Browse Branches

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