- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873106
Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography
September 5, 2012 updated by: Birgit Sander, Glostrup University Hospital, Copenhagen
The purpose of the present study is to determine if the retinal thickness estimates of the Stratus OCT, the 3D OCT-1000, and the CirrusHD OCT are comparable in diabetic and in healthy individuals (OCT=Optical Coherence Tomography).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
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
-
-
Copenhagen
-
Glostrup, Copenhagen, Denmark, DK-2600
- Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A group of diabetic and healthy participants
Description
Inclusion Criteria:
- diabetic retinopathy in the diabetic group
- healthy retinas in the healthy group
Exclusion Criteria:
- not able to cooperate
- retinal disease other than macular oedema
- severe media opacities (e.g. cataract)
- prior macular laser photocoagulation except for large oedemas
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: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinal thickness and retinal volume from each OCT scan
Time Frame: within 24 hours
|
within 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dorte Nellemann Thornit, MD, Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
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, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 18, 2009
First Submitted That Met QC Criteria
March 31, 2009
First Posted (Estimate)
April 1, 2009
Study Record Updates
Last Update Posted (Estimate)
September 6, 2012
Last Update Submitted That Met QC Criteria
September 5, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCT comparison
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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