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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014