Validity of Postmortem Glycated Hemoglobin to Determine Status of Diabetes Mellitus in Corneal Donors

Soper, Mark; Marcovina, Santica M.; Hoover, Caroline; Calhoun, Peter; McCoy, Kristen; Stoeger, Christopher G.; Schmidt, Gregory A.; Arafah, Baha M.; Price, Marianne O.; Szczotka-Flynn, Loretta; Lass, Jonathan H.

doi:10.1097/ico.0000000000001211

Cited by 7 publications

(4 citation statements)

References 14 publications

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“…Having shown the effect of diabetes in the donor on both ECL and lower graft success compared with the previous literature, a randomized clinical trial seems warranted based on rigorous assessment of diabetes status of the donor. To provide greater precision in such a trial, diabetes should be better characterized in the donor as well as the recipient, by not only historical means, but also via diabetes severity grading, as well as hemoglobin A 1c testing to enable the detection of undiagnosed diabetes…”

Section: Discussionmentioning

confidence: 99%

Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

et al. 2019

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; for the Cornea Preservation Time Study Group IMPORTANCE Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival. OBJECTIVE To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study. DESIGN, SETTING, AND PARTICIPANTS This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included. INTERVENTIONS The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days. MAIN OUTCOMES AND MEASURES Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images. RESULTS The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (−103 [−196 to −9] cells/mm 2), lower screening ECD (−234 [−331 to −137] per 500 cells/mm 2), recipient diagnosis of PACE (−257 [−483 to −31] in cells/mm 2), and operative complications (−324 [−516 to −133] in cells/mm 2). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47% (99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43% (99% CI, 39%-48%) without diabetes; it was 53% (99% CI, 44%-62%) for participants diagnosed with PACE vs 44% (99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55% (99% CI, 48%-63%) in participants who experienced operative complications vs 44% (99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD. CONCLUSIONS AND RELEVANCE Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.

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Section: Discussionmentioning

confidence: 99%

Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

et al. 2019

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“…Further studies are needed to validate this finding, ideally in a randomized clinical trial. The trial should examine the impact of the severity and duration of diabetes and the systemic sequelae of diabetes on long-term graft success and endothelial cell loss 38 as well as include postmortem HbA1c testing to further characterize diabetes control and detect undiagnosed donors with diabetes 44 . Further delineating diabetes severity may not only assist in deciding which donors with diabetes are at greatest risk for graft failure; it may also address concerns on which of these donors are suitable for DMEK lenticule preparation without damaging the tissue.…”

Section: Discussionmentioning

confidence: 99%

Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study

et al. 2018

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Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.

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“…Diabetes in our corneal donors was determined from medical records and interviews of associated health care personnel and/or next of kin, if available. 1,8 Future studies are suggested to better characterize diabetes in the donor based on duration, severity 35 and HbA1c testing 36 to identify donors with diabetes whose corneas would be more prone to graft dislocation and failure following endothelial keratoplasty surgery.…”

Section: Discussionmentioning

confidence: 99%

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

Aldave

Terry

Szczotka-Flynn

et al. 2019

American Journal of Ophthalmology

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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: 1,090 individuals (1,330 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 Aldave et al.

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Validity of Postmortem Glycated Hemoglobin to Determine Status of Diabetes Mellitus in Corneal Donors

Cited by 7 publications

References 14 publications

Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study

Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study

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

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