Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study

the Cornea Preservation Time Study Group

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Purpose: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. Design: Cohort study within a multi-center, double-masked, randomized clinical trial. Methods: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). Results: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (–479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. Conclusions: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.

Original languageEnglish (US)
Pages (from-to)78-88
Number of pages11
JournalAmerican journal of ophthalmology
Volume203
DOIs
StatePublished - Jul 2019
Externally publishedYes

Bibliographical note

Funding Information:
All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Financial Disclosures: The following authors have financial disclosures with companies that manufacture corneal storage solutions (considered relevant to this work): Mark Terry (Bausch & Lomb), and W. Barry Lee (Bausch & Lomb) (part of the CPTS Study Group but not an author of this article). Jonathan Lass is an Eversight and Cleveland Eye Bank Foundation Board member and medical director (Cleveland, Ohio); Maureen Maguire received payment from Genentech/Roche for service on a data monitoring committee for a clinical trial; Loretta Szczotka-Flynn is a consultant for Johnson & Johnson Vision Care, Inc. and Alcon Laboratories (consulting); Robin Chalmers is on the adjudication panel; Mark Terry has received support from Bausch and Lomb (royalties on instruments for DSAEK and unrestricted educational grant for EKG breakfast), Moria (unrestricted educational grant for EKG breakfast), and Envisia (Safety Monitoring Board for Glaucoma Study). All other authors have no financial disclosures related to this manuscript. Funding/Support: Supported by cooperative agreements with the National Eye Institute,National Institutes of Health,Department of Health and Human Services EY20797 (A.R.A) and EY20798 (J.H.L.). 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. All authors attest that they meet the current ICMJE criteria for authorship. The Cornea Preservation Time Study Group, The comprehensive list of participating Cornea Preservation Time Study 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, 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;135:1401-1409).

Funding Information:
All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. Financial Disclosures: The following authors have financial disclosures with companies that manufacture corneal storage solutions (considered relevant to this work): Mark Terry (Bausch & Lomb), and W. Barry Lee (Bausch & Lomb) (part of the CPTS Study Group but not an author of this article). Jonathan Lass is an Eversight and Cleveland Eye Bank Foundation Board member and medical director (Cleveland, Ohio); Maureen Maguire received payment from Genentech / Roche for service on a data monitoring committee for a clinical trial; Loretta Szczotka-Flynn is a consultant for Johnson & Johnson Vision Care, Inc. and Alcon Laboratories (consulting); Robin Chalmers is on the adjudication panel; Mark Terry has received support from Bausch and Lomb (royalties on instruments for DSAEK and unrestricted educational grant for EKG breakfast), Moria (unrestricted educational grant for EKG breakfast), and Envisia (Safety Monitoring Board for Glaucoma Study). All other authors have no financial disclosures related to this manuscript. Funding/Support: Supported by cooperative agreements with the National Eye Institute,National Institutes of Health,Department of Health and Human Services EY20797 (A.R.A) and EY20798 (J.H.L.). 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 . All authors attest that they meet the current ICMJE criteria for authorship.

Publisher Copyright:
© 2019 Elsevier Inc.

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

Fingerprint

Dive into the research topics of 'Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study'. Together they form a unique fingerprint.

Cite this