Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

June 24, 2013 updated by: Carl Zeiss Meditec, Inc.
The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Study Type

Observational

Enrollment (Actual)

91

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
      • Oakland, California, United States, 94609
        • East Bay Retina
      • San Francisco, California, United States, 94107-1756
        • West Coast Retina
    • Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute
    • Michigan
      • Lansing, Michigan, United States, 48912
        • TLC Eyecare and Laser Centers

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:

  • 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 upon dilated examination, or upon evaluation of retinal photos.
  • Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
  • Concomitant use of hydrochloroquine and chloroquine.
  • Unable to make the required study visits.
  • 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
Dry AMD with macular drusen
Patients diagnosed with dry AMD with macular drusen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Time Frame: Study was released before December 1, 2012
Study was released before December 1, 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.
Time Frame: Study was released before December 1, 2012
Study was released before December 1, 2012

Other Outcome Measures

Outcome Measure
Time Frame
To describe the qualitative similarities and differences between the areas designated as elevated RPE by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Time Frame: Study was released before December 1, 2012
Study was released before December 1, 2012

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: Philip Rosenfeld, MD, Bascom Palmer Eye Institute
  • Principal Investigator: Carmelina Gordon, MD, TLC Eyecare and Laser Center
  • Principal Investigator: Eugene Lit, MD, East Bay Retina Consultants

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

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

June 25, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-OCT-DR-2010-1

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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