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NCT00873106 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00873106
Other study ID # OCT comparison
Secondary ID
Status Completed
Phase N/A
First received March 18, 2009
Last updated September 5, 2012
Start date February 2009
Est. completion date March 2010

Study information
Verified date September 2012
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57 Glostrup Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retinal thickness and retinal volume from each OCT scan within 24 hours No
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