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Jonathan H. Lass, MD; Alan Sugar, MD; Beth Ann Benetz, MA; Roy W. Beck, MD, PhD; Mariya Dontchev, MPH; Robin L. Gal, MSPH; Craig Kollman, PhD; Robert Gross, MD; Ellen Heck, MS, MA; Edward J. Holland, MD; Mark J. Mannis, MD; Irving Raber, MD; Walter Stark, MD; R. Doyle Stulting, MD, PhD; for the Cornea Donor Study Investigator Group

Arch Ophthalmol. 2010;128(1):63-69. doi:10.1001/archophthalmol.2010.128.63

Objective  To determine whether preoperative and/or postoperative central endothelial cell density (ECD) and its rate of decline postoperatively are predictive of graft failure caused by endothelial decompensation following penetrating keratoplasty to treat a moderate-risk condition, principally, Fuchs dystrophy or pseudophakic corneal edema.

Methods  In a subset of Cornea Donor Study participants, a central reading center determined preoperative and postoperative ECD from available specular images for 17 grafts that failed because of endothelial decompensation and 483 grafts that did not fail.

Results  Preoperative ECD was not predictive of graft failure caused by endothelial decompensation (P = .91). However, the 6-month ECD was predictive of subsequent failure (P < .001). Among those that had not failed within the first 6 months, the 5-year cumulative incidence (±95% confidence interval) of failure was 13% (±12%) for the 33 participants with a 6-month ECD of less than 1700 cells/mm² vs 2% (±3%) for the 137 participants with a 6-month ECD of 2500 cells/mm² or higher. After 5 years' follow-up, 40 of 277 participants (14%) with a clear graft had an ECD below 500 cells/mm².

Conclusions  Preoperative ECD is unrelated to graft failure from endothelial decompensation, whereas there is a strong correlation of ECD at 6 months with graft failure from endothelial decompensation. A graft can remain clear after 5 years even when the ECD is below 500 cells/mm².

Clinical Trial Registry  clinicaltrials.gov Identifier: NCT00006411

Author Affiliations: Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, Ohio (Dr Lass and Ms Benetz); W. K. Kellogg Eye Center, University of Michigan, Ann Arbor (Dr Sugar); Jaeb Center for Health Research, Tampa, Florida (Drs Beck and Kollman and Mss Dontchev and Gal); Cornea Consultants of Arizona, Phoenix (Dr Gross); Transplant Services Center, The University of Texas Southwestern Medical Center at Dallas (Ms Heck); Cincinnati Eye Institute, Cincinnati, Ohio (Dr Holland); Department of Ophthalmology and Vision Science, University of California–Davis, Sacramento (Dr Mannis); Ophthalmic Partners of Pennsylvania, Bala Cynwyd (Dr Raber); The Johns Hopkins University School of Medicine, The Wilmer Ophthalmological Institute, Baltimore, Maryland (Dr Stark); and Department of Ophthalmology, Emory University, Atlanta, Georgia (Dr Stulting).

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