NCT01890174

Completed

Repeatability and Reproducibility of Cirrus HD-OCT Macular R...

Carl Zeiss Meditec, Inc.Source

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Other study identifiers

Sponsor study identifier

HD-OCT-DR-2010-2

Study Type

observational

Actual enrollment (reported)

54

Locations

1 country

Sites

1

Timeline

Study Start

February 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2011

Actual (reported)

Study Completion

June 2011

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 54 participants
Study completion date: June 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2011
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)
Study Completion
June 2011
Actual (reported)
First Submitted
June 24, 2013
Actual (reported)
First Posted
July 1, 2013
Actual (reported)

Last Updated: July 1, 2013
Status Verified: June 2013
Last Update Submitted: June 27, 2013

Conditions

Dry AMD With Macular Drusen

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Other Outcomes (2)

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

Study Arms (1)

AMD with macular drusen

Patients diagnosed with dry AMD with macular drusen

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Primary care clinic

You may qualify if:

Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen.

Sponsors & Collaborators

DataMed Devices Inc.
Industrycollaborator
Carl Zeiss Meditec, Inc.
Industrylead

Study Sites (1)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Related Publications (1)

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.
PMID: 19171212BACKGROUND

Study Officials

Mark Wieland, MD
Northern California Retina Vitreous Associates Medical Group, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

54 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 1, 2013

Study Start

February 2011

Date type not reported

This date has not been verified as actual or estimated.

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

June 2011

Actual (reported)

Study Completion

June 2011

Actual (reported)

Last Updated

July 1, 2013

Record last verified: 2013-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01890174
Data provider: ClinicalTrials.gov
Source updated: 2013-07-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:20 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (1)

AMD with macular drusen

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations