Purchase this article with an account.
B.E. McCarey, J.J. Walter, T.R. Paul; Specular Microscopy of Control Eyes in a Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4793.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose. Corneal endothelial cell morphology analysis is presented from adult patient control eyes enrolled in a multi–center clinical trial. Methods. The Konan Clinical Specular Microscope was used to document the corneal endothelial cell pattern (3 images per eye) from patients (n=121) enrolled in a clinical trial at ten clinical sites. The endothelial cell pattern was documented at multiple visits during approximately a one–year period. The image files were sent to a specular microscopy reading center for analysis of cell density (CD), coefficient of variation (CV), per cent of hexagon cells (%H) and number of cells counted (NUM). The reading center performed the analysis using the center to center algorithm in the KSS300 software (Konan Corp.) The endothelial cell change from the initial (baseline) cell density was determined. Group analysis of CV, %H, and NUM were performed. Results. A linear regression analysis of 1440 images for the CD % change from baseline with respect to follow up time yielded a line defined by Y=–0.224X+0.081 (r=0.276). The line has a –2.8% cell density change per year. The probability of there being a relationship between CD change and time is p=0.05. In another analysis, the cell loss (slope) determined for each patient (n=120) was averaged with a resulting –2.8% cell density change per year +/–9.3% (SD). The average baseline (n=121) value for CD was 2742±364, for CV was 35±6, for %H is 57±7, and average number of cells counted was 110±31. The correlation coefficient for the CV verses cell density relationship was r=0.095. The correlation coefficient for the CD verses number of cell counted relationship was r=0.405. The latter relationship is defined by the set dimensions of the image frame and decreasing number of cells captured with decreasing cell density. Conclusions. The corneal endothelial cell morphology analysis for normal control eyes enrolled in a multi–center clinical trail had greater than –2.7% endothelial cell density change per year.
This PDF is available to Subscribers Only