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Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT00873106
Recruitment Status : Completed
First Posted : April 1, 2009
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Healthy Diabetic Maculopathy Device: Optical coherence tomography

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography
Study Start Date : February 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010
Groups and Cohorts

Intervention Details:
    Device: Optical coherence tomography
    Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT

Outcome Measures

Primary Outcome Measures :
  1. Retinal thickness and retinal volume from each OCT scan [ Time Frame: within 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A group of diabetic and healthy participants
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873106


Locations
Denmark
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57
Glostrup, Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Dorte Nellemann Thornit, MD Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57, DK-2600 Glostrup, Denmark
More Information

Responsible Party: Birgit Sander, ph.d, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00873106     History of Changes
Other Study ID Numbers: OCT comparison
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012