Clinical and Pathophysiological Description of Ocular Isc... | NCT00403195

Studies
Clinical and Pathophysiological Description of Ocular Ischemic Syndrome

NCT00403195

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Sep 10, 2012Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Retinal Degeneration
Diabetic Retinopathy

Interventions

Not provided

Countries

Denmark

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

Sep 2012

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

Nov 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Nov 21, 2006

First Submission Date that Met QC Criteria

Nov 21, 2006

First Posted Date

Nov 23, 2006Estimated

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

Sep 7, 2012

Last Update Posted Date

Sep 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Kofoed, Principal investigator, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Name	Class
Rigshospitalet, Denmark	OTHER
University Hospital, Gentofte, Copenhagen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.

Detailed Description

The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.

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

No data available

No data is available for this block.

Enrollment

13Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ocular ischemic syndrome

Exclusion Criteria:

Any other active ocular disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with the disease ocular ishemic syndrome. Patients will be screened through vascular surgery departments.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Larsen, Professor		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen		Glostrup Municipality		2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19933192	Derived	Kofoed PK, Munch IC, Sander B, Holfort SK, Sillesen H, Jensen LP, Larsen M. Prolonged multifocal electroretinographic implicit times in the ocular ischemic syndrome. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1806-10. doi: 10.1167/iovs.09-4555. Epub 2009 Nov 20.

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D012164	Retinal Diseases
D003925	Diabetic Angiopathies

ID	Term
D012162	Retinal Degeneration
D003930	Diabetic Retinopathy