Diabetic Retinopathy Clinical Research Network (DRCRnet) public web site

Protocol: Comparison of Time Domain OCT and Spectral Domain OCT Retinal Thickness Measurement in Diabetic Macular Edema
Status: Closed
Start Date: 05/14/2009
End Date: 01/31/2013
Clinical Trial ID:  
Public Dataset:  

 

Comparison of Time Domain OCT  and Spectral Domain OCT  Retinal Thickness Measurement  in Diabetic Macular Edema

 

Protocol Status: Open to Enrollment

"Click here to view protocol"

A. Study Objective

The primary objectives of the study are as follows:

  • Compare thickness measurements between Zeiss TD Stratus OCT and selected SD OCT machines (Zeiss Cirrus, Heidelberg Spectralis, Topcon 3D-OCT, and Optovue RTVue), estimating a conversion factor between TD OCT and SD OCT
  • Assess and compare the reproducibility of the selected SD OCT machines utilizing their respective software analysis algorithms

 

B. Major Eligibility Criteria

  • Age >=18 years
  • Type 1 or type 2 diabetes
  • Media clarity adequate for obtaining OCT images
  • Presence of DME in at least one eye (as defined by central subfield thickness on Stratus OCT of 250 microns or greater)

 

C. Summary of Study Protocol

 The study will enroll approximately 800 subjects with DME in at least one eye. Each subject will have two OCT measurements made on each eye using the TD Stratus OCT3 machine and two measurements using each of any of the following SD OCTs available at the site: Zeiss Cirrus, Heidelberg Spectralis, Topcon 3D-OCT, and Optovue RTVue. Not all subjects will have measurements on all SD OCT machines. All measurements will be completed by the same operator and obtained within 2 hours of the initial measurement. The Zeiss Stratus OCT should be obtained first. The order of the spectral domain OCT machines will be based on convenience of availability. If more than 2 hours transpire between the initial Zeiss Stratus OCT measurement and the final spectral domain OCTmeasurement, one repeat Zeiss Stratus OCT measurement should be obtained to assess for diurnal variation. The images will be sent to the DRCR.net Coordinating Center (uploaded through the website as available).

 


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