Repeatability and Reproducibility of Cirrus HD-OCT Macula... | NCT01890174

Studies
Repeatability and Reproducibility of Cirrus HD-OCT Macular Retinal Pigment Epithelium Elevation

NCT01890174

Sponsor

Carl Zeiss Meditec, Inc.

Status

Completed

Last Update Posted

Jul 1, 2013Estimated

Enrollment

54Actual

Phase

Not provided

Conditions

Dry AMD With Macular Drusen

Interventions

Not provided

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

Jun 2013

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

Feb 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 24, 2013

First Submission Date that Met QC Criteria

Jun 27, 2013

First Posted Date

Jul 1, 2013Estimated

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

Jun 27, 2013

Last Update Posted Date

Jul 1, 2013Estimated

Name	Class
DataMed Devices Inc.	INDUSTRY

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 objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

Detailed Description

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of drusen area and volume will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

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

54Actual

Label	Type	Description	Intervention Names
AMD with macular drusen		Patients diagnosed with dry AMD with macular drusen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 3 mm circle.		Single visit observation

Secondary Outcomes

Measure	Description	Time Frame
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 3 mm circle.		Single visit observation

Other Outcomes

Measure	Description	Time Frame
Coefficient of variation for area (mm^2) of RPE elevation measurements in the central 5 mm circle.		Single visit observation
Coefficient of variation for volume (mm^3) of RPE elevation measurements in the central 5 mm circle.		Single visit observation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.
Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
Able and willing to make the required study visits.
Able and willing to give consent and follow study instructions.

Exclusion Criteria:

History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
Concomitant use of hydrochloroquine or chloroquine.
Unable to make the required study visits.
Unable to give consent or follow study instructions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Wieland, MD	Northern California Retina Vitreous Associates Medical Group, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern California Retina Vitreous Associates		Mountain View	California	94040	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19171212	Background	Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus autofluorescence and progression of age-related macular degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117. doi: 10.1016/j.survophthal.2008.10.004.