Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium

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 measurement of illumination areas under the retinal pigment epithelium (RPE).

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 illumination areas under the RPE will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of illumination areas under the RPE 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)

85

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
      • Walnut Creek, California, United States, 94107
        • West Coast Retina

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 and older diagnosed to have advanced dry AMD with geographic atrophy.

  • Geographic atrophy lesions should:

    • Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
    • Not be smaller than 1.25 mm2.
    • Not be confluent with peri-papillary atrophy.
    • Not be combined with other lesions such as CNV.
  • 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.

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

Cohorts and Interventions

Group / Cohort
Advanced dry AMD with geographic atrophy
Patients diagnosed with advanced dry AMD with geographic atrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coefficient of variation for area of increased illumination under the RPE (mm^2)
Time Frame: Single visit observation
Single visit observation

Secondary Outcome Measures

Outcome Measure
Time Frame
Coefficient of variation of the closest distance to fovea
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.

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

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-OCT-GA-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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