To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study.
One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (N = 675) or 8 to 14 days (N = 655). Donor factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications.
The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 μm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06–1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 μm (99% CI: 516 μm–558 μm) compared with 567 μm (99% CI: 546 μm–588 μm) for PT 8 to 14 days (P < 0.001).
Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.
*Eversight (formerly Midwest Eye-Banks), Ann Arbor, MI;
†Lions VisionGift, Portland, OR;
‡Central Pennsylvania Eye Institute, Hershey, PA;
§Jaeb Center for Health Research, Tampa, FL. Dr. O'Brien is now with the University of Mississippi Medical Center, Jackson, MS;
¶Case Western Reserve University, Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, OH;
‖Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;
**Eye-Bank for Sight Restoration, New York, NY;
††Transplant Services, University of Texas, Southwestern, Dallas, TX;
‡‡Michigan Cornea Consultants, P.C., Southfield, MI;
§§CorneaGen (formerly Tissue Banks International, and KeraLink International), Baltimore, MD;
¶¶CorneaGen (formerly SightLife), Seattle, WA;
‖‖Northshore University Health System, Glenview, IL;
***Kellogg Eye Center, University of Michigan, Ann Arbor, MI;
†††Cincinnati Eye Institute, Cincinnati, OH;
‡‡‡San Diego Eye Bank, San Diego, CA;
§§§VisionFirst (formerly Indiana Lions Eye Bank), Indianapolis, IN;
¶¶¶Devers Eye Institute, Portland, OR
‖‖‖Verdier Eye Center, Grand Rapids, MI; and
****Alabama Eye Bank, Birmingham, AL.
Correspondence: Jonathan H. Lass, MD, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106 (e-mail: email@example.com).
Supported by cooperative agreements with the National Eye Institute, National Institutes of Health, and 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. A. Terry (Bausch & Lomb) and W. B. Lee (Bausch & Lomb) (part of the CPTS Study Group but not an author on this paper). The following authors are employed by eye banks: K. W. Ross (Eversight), C. G. Stoeger (Lions VisionGift), P. Dahl (Eye-Bank for Sight Restoration), D. C. Drury (Transplant Services, University of Texas, Southwestern), S. M. Farazdaghi (CorneaGen), C. K. Hoover (CorneaGen), J. G. Penta (San Diego Eye Bank), M. C. Soper (Vision First), and D. V. Williams (Alabama Eye Bank). J. H. Lass is a voluntary board member of Eversight and the Cleveland Eye Bank Foundation. These interests did not conflict with the conduct of this study.
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 comprehensive list of participating CPTS clinical sites, investigators, and coordinators; eye bank investigators; members of the Operations, Executive, Eye Bank Advisory, Data and Safety Monitoring Committee; Coordinating Center, Cornea Image Analysis Reading Center (CIARC), and Data Management and Analysis Center Staff; and the National Eye Institute staff have been previously published (Cornea. 2015;34:601–608; JAMA Ophthalmology. 2017:1401–09)
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 was 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 March 30, 2019
Received in revised form May 08, 2019
Accepted May 15, 2019
Online date: June 5, 2019