- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890187
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
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California
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Walnut Creek, California, United States, 94107
- West Coast Retina
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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 |
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Advanced dry AMD with geographic atrophy
Patients diagnosed with advanced dry AMD with geographic atrophy
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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
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Single visit observation
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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
Collaborators
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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