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

June 27, 2013 updated by: Carl Zeiss Meditec, Inc.
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurements of drusen area and volume.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
AMD with macular drusen
Patients diagnosed with dry AMD with macular drusen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec, Inc.

Collaborators

DataMed Devices Inc.

Investigators

  • Principal Investigator: Mark Wieland, MD, Northern California Retina Vitreous Associates Medical Group, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 24, 2013

First Submitted That Met QC Criteria

June 27, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

July 1, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • HD-OCT-DR-2010-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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