To evaluate agreement between eye banks (EBs) and a reading center on endothelial cell density (ECD) determinations in the Cornea Preservation Time Study.
The Cornea Image Analysis Reading Center (CIARC) performed variable frame image analysis on EB-obtained–preoperative central endothelial images (after lamellar dissection for Descemet stripping automated endothelial keratoplasty by the EBs or before shipping, if surgeon prepared) to determine ECD. The EBs performed their usual method of ECD determination. The CIARC and EBs also provided ECD determinations from screening central endothelial images taken by the EBs during donor evaluation. Two independent masked CIARC readers determined ECD with measurements averaged.
The mean preoperative ECD was 15 cells/mm2 greater by the EBs than by CIARC (N = 1286, P < 0.001) with 95% limits of agreement of (−644, 675 cells/mm2). The limits of agreement in preoperative ECD were wider in the After-Lamellar-Dissection Group (−687, 683 cells/mm2) than in the Before Shipping Group [(−505, 633 cells/mm2); P = 0.03]. The EBs-determined preoperative ECD was within 10% of the CIARC-determined ECD for 886 (69%) image sets, with 236 (18%) higher by >10% and 164 (13%) lower by >10%. Excellent agreement appeared between the EBs and CIARC when 100–300 cells could be analyzed in contrast to <100 cells (SD = 308 cells/mm2 vs. SD = 603 cells/mm2; P < 0.001).
The mean ECD by the EBs and CIARC were similar, but there was considerable variability between determinations for individual corneas. Agreement improved between the 2 measurements when more than 100 cells were able to be analyzed.
*Department of Ophthalmology and Visual Sciences, Case Western Reserve University, University Hospitals Eye Institute, Cleveland, OH;
†Cornea Image Analysis Reading Center (CIARC), Department of Ophthalmology and Visual Sciences, Case Western Reserve University, University Hospitals Eye Institute, Cleveland, OH;
‡Lions VisionGift, Portland, OR;
§Department of Ophthalmology, Mayo Clinic, Rochester, MN;
¶Jaeb Center for Health Research, Tampa, FL;
‖Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;
**Lions Gift of Sight (formerly Minnesota Lions Eye Bank), Minneapolis, MN;
††Eversight Ohio, Cleveland, OH;
‡‡Eversight Illinois, Chicago, IL; and
§§University of Southern California Roski Eye Institute, Los Angeles, CA.
Correspondence: Jonathan H. Lass, MD, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland 44106-5068, OH (e-mail: firstname.lastname@example.org).
Supported by cooperative agreements with the National Eye Institute, National Institutes of Health, Department of Health and Human Services EY20797 and EY20798.
The following authors have financial disclosures with companies that manufacture corneal storage solutions (considered relevant to this work): M. Terry (Bausch & Lomb), and W.B. Lee (Bausch & Lomb) (part of CPTS Study Group but not authors on this paper). These authors are employed by eye banks: C. G. Stoeger and J. M. Clover (Lions VisionGift), P. Bedard (Lions Gift of Sight), and K. E. McCoy (Eversight). J. H. Lass is a voluntary board member of Eversight and the Cleveland Eye Bank Foundation. The remaining authors have no conflicts of interest to disclose.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.corneajrnl.com).
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Eye Institute or the National Institutes of Health. Additional support provided by: Eye Bank Association of America, The Cornea Society, Vision Share, Inc., Alabama Eye Bank, Cleveland Eye Bank Foundation, Eversight, Eye Bank for Sight Restoration, Iowa Lions Eye Bank, Lions Eye Bank of Albany, San Diego Eye Bank, and SightLife.
Received September 28, 2018
Accepted November 14, 2018