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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birgit Sander, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00873106
First received: March 18, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention
Healthy
Diabetic Maculopathy
Device: Optical coherence tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Retinal Thickness and Volume Estimates Given by Time Domain and Spectral Optical Coherence Tomography

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • Retinal thickness and retinal volume from each OCT scan [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Optical coherence tomography
    Stratus OCT: fast radial lines 3D OCT-1000: radial 2048 and 3D OCT Cirrus HD OCT: 3D OCT
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Birgit Sander, ph.d, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT00873106     History of Changes
Other Study ID Numbers: OCT comparison
Study First Received: March 18, 2009
Last Updated: September 5, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

ClinicalTrials.gov processed this record on April 14, 2014