Stratus Versus Cirrus OCT in AMD | NCT00568191

Studies
Stratus Versus Cirrus OCT in AMD

NCT00568191

Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery

Status

Unknown status

Last Update Posted

Dec 5, 2007Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Age-Related Macular Degeneration
Choroidal Neovascularization

Interventions

Not provided

Countries

Austria

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

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

Dec 4, 2007

Last Update Posted Date

Dec 5, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryOTHER

Collaborators

Not provided

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

The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		retinal thickness program Stratus OCT software 4.0
2		retinal cube 200x200 program of Cirrus OCT

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of algorithm failures assessed by Stratus OCT versus Cirrus OCT in the horizontal central line		only 1 examination

Secondary Outcomes

Measure	Description	Time Frame
Number of algorrithm failures in Stratus versus Cirrus OCT assessed in the whole scan		1 examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>55 years
Age-related macular degeneration

Exclusion Criteria:

Not consented patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients aged > 55 years of either sex presenting with age-related macular degeneration

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ilse Krebs, MD	Contact	+43171165	94607	Ilse.Krebs@wienkav.at

Overall Officials

Name	Affiliation	Role
Ilse Krebs	Ludwig Boltzmann Institute of Retinology and Biomicroscopic Lasersurgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery	Recruiting	Vienna	State of Vienna	A1030	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19029035	Derived	Krebs I, Falkner-Radler C, Hagen S, Haas P, Brannath W, Lie S, Ansari-Shahrezaei S, Binder S. Quality of the threshold algorithm in age-related macular degeneration: Stratus versus Cirrus OCT. Invest Ophthalmol Vis Sci. 2009 Mar;50(3):995-1000. doi: 10.1167/iovs.08-2617. Epub 2008 Nov 21.

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization