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• W4238223398 abstract "Dr Rosa's criticism of the statistics in our article misses the major point of our presentation. We evaluated both eyes of 10 subjects with diabetic macular edema in one eye (2 subjects) or both eyes for variation in macular thickness, measured by optical coherence tomography (OCT) over the course of a waking day, beginning at 8 am just after each subject had arisen from a night's sleep. One subject showed consistent decreases in all of the 9 macular zones defined by the OCT instrument in both eyes, with the maximum thickness measured at the initial daily measurement at 8 am. Three other subjects showed consistent decreases in thickness in some but not all of the macular zones in one or both eyes over the 8 am to 5 pm measurement cycle. No subject showed an increase in macular thickness over the day. These OCT measurements confirm the earlier observations of Sternberg et al,1Sternberg Jr, P. Fitzke F. Finkelstein D. Cyclic macular edema.Am J Ophthalmol. 1982; 94: 664-669PubMed Scopus (27) Google Scholar that some individuals with diabetic (or other) macular edema show a decrease in that edema over the course of a waking day. Their conclusions were based on psychophysical studies before the introduction of OCT. Dr Rosa's criticism is based on our statistical determinations. From a formal point of view, this criticism is correct. When the number of observations is small (in our case, n = 10) and one cannot demonstrate a Gaussian distribution of the data points, parametric statistics such as the t test may be inappropriate. However, as Motulsky points out,2Motulsky H. Analyzing Data with GraphPad Prism: A Companion to GraphPad Prism Version 3. GraphPad Software, San Diego1999Google Scholar it is difficult to demonstrate even an approximately Gaussian distribution unless the sample size is quite large, and many biological studies calculate results using parametric statistics with sample sizes comparable to those that we used (cf. examples given by Armitage3Armitage P. Statistical Methods in Medical Research. Blackwell Science, Oxford, United Kingdom1971Google Scholar). In the present case, this does not matter because, although a single t test comparing the 8 am and 11 am average macular thickness values is highly significant, another parametric test (1-way analysis of variance) shows no significant difference when all 4 temporal measurements are compared. We could have adjusted for small sample sizes by performing a logarithmic transformation of the data or by using a nonparametric test. But when one parametric test gave a nonsignificant result, conducting these additional analyses would have been fruitless. Additionally, Dr Rosa chides us for stating certain conclusions without presenting all the data. In fact, the first point that Dr Rosa questions is demonstrated in our Figure 3. We did not discuss Dr Rosa's second point in our initial submission of this article, but in response to a reviewer's comment, we calculated the mean thickness of the 9 macular zones and compared them as a function of position in the superior or inferior portions of the macula. The actual data were submitted to the reviewers and to the Editor for their personal evaluation, to be published if journal space was available. If Dr Rosa or any other reader would like to see these data, we will be pleased to e-mail them. Having said that, however, we can categorically state that, for our major conclusion, these criticisms are irrelevant. Dr Rosa states, “At first glance, it seems to me that . . . there are no diurnal changes in most of the patients.” (We agree.) “But to understand these data better, there needs to be correct statistical evaluation.” (We strongly disagree.) Although we did look at average macular thickness values (our Fig 4) to show a temporal trend, our most important conclusions are the individual macular thickness values from each subject (Fig 3). Our major take-home point is stated in the “Conclusions” section of our abstract: “Although changes in macular thickness over the course of the day did not occur in all subjects, therapeutic studies for macular edema that use OCT as an outcome measure should control for time of day when these measurements are carried out.” This conclusion is based on the individual responses of subjects with macular edema and does not require statistical evaluation. We argue that failure to observe this source of temporal variation that occurs in some individuals may be an important confounder in the growing number of studies that use OCT to determine therapeutic response to various interventions for the treatment of macular edema in diabetic retinopathy and other diseases. Variation in diabetic macular edemaOphthalmologyVol. 111Issue 10PreviewIn the February 2004 article by Frank et al,1 the authors evaluated 10 diabetic patients who had clinically significant macular edema in at least one eye. Because the authors state that in 2 eyes there was no macular edema, they evaluated only 18 eyes. These eyes were evaluated over the day with optical coherence tomography, and the authors concluded using optical coherence tomography that macular edema might vary over the day. Full-Text PDF" @default.
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• W4238223398 date "2004-10-01" @default.
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• W4238223398 doi "https://doi.org/10.1016/j.ophtha.2004.07.006" @default.
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