Original ArticleReproducibility of Macular Thickness and Volume Using Zeiss Optical Coherence Tomography in Patients with Diabetic Macular Edema
Section snippets
Patients and Methods
The protocol and informed consent forms were approved by individual sites’ institutional review boards. Each participant gave written informed consent for participation in the study. The protocol for the study of the diurnal changes in retinal thickness is described in a separate article4 and is available on the Diabetic Retinopathy Clinical Research Network web site (www.drcr.net; date accessed, October 1, 2006).
Participants in the study had at least 1 eye with edema in the center of the
Results
The 107 participants had an average age (±standard deviation) of 59±10 years; 49 (46%) were women, 73 (68%) were white, 16 (15%) were black, 16 (15%) were Hispanic, and 2 (2%) were of other races. Type 1 diabetes was present in 16 (15%) participants, and type 2 diabetes was present in 91 (85%) participants. Average duration of diabetes (±standard deviation) was 17±9 years, and mean (±standard deviation) glycosylated hemoglobin was 7.7±1.6%. Eighteen (8%) of the 212 eyes had average central
Discussion
This study provides detailed information on the reproducibility of OCT measurements of retinal thickness in the setting of DME. The information is important to the clinician in assessing whether there has been a true change in retinal thickness between visits. The data are also valuable for clinical trial design and evaluation in terms of defining OCT outcome measures and in estimating sample size and power for comparing change in OCT measures between treatment groups. Although measurement of
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Manuscript no. 2006-902.
Dr Bressler’s employer, Johns Hopkins University School of Medicine, but not Dr Bressler, is paid for research services provided by Dr Bressler to Zeiss Meditec, Inc. The terms of this institutional arrangement are managed by Johns Hopkins University in accordance with its conflict of interest policies.
Supported by a cooperative agreement from the National Eye Institute, Bethesda, Maryland, and National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland (grant nos. EY14231, EY14269, EY14229).
E-mail: [email protected].
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Names of members of the writing committee appear in “Appendix.” The most recently published list of the Diabetic Retinopathy Clinical Research Network can be found in Diabetic Retinopathy Clinical Research Network,4 with a current list available at http://www.drcr.net.