Trial reportOphthalmology2015
The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty.
Trial report in Ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00006411 (Cornea Donor Study), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cornea Donor Study: The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- A systematic review on the impact of diabetes mellitus on the ocular surface.Nutrition & diabetes · 2017Pooled it
- Endothelial Cell Loss 1 Year After Successful DMEK in the Diabetes Endothelial Keratoplasty Study: A Randomized Clinical Trial.JAMA ophthalmology · 2025Trial
- Donor Diabetes and 1-Year Descemet Membrane Endothelial Keratoplasty Success Rate: A Randomized Clinical Trial.JAMA ophthalmology · 2025Trial
- Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.American journal of ophthalmology · 2019Trial
- Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study.JAMA ophthalmology · 2019Trial
- Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.Ophthalmology · 2018Trial
- Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.Cornea · 2015Trial
- Impact of recipient and donor factors on corneal graft clearance: insights from serial anterior segment optical coherence tomography.AJO international · 2025Article
- [DMEK for endothelial decompensation after penetrating keratoplasty].Die Ophthalmologie · 2025Article
- Correlation between preoperative aqueous cytokine levels and mid-term corneal endothelial cell loss following penetrating keratoplasty.Eye (London, England) · 2025Article
- The impact of donor diabetes on corneal transplant immunity.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2023Article
- Endothelial failure and rejection in recipients of corneas from the same donor.BMJ open ophthalmology · 2022Article
- Pathogenic Role of Endoplasmic Reticulum Stress in Diabetic Corneal Endothelial Dysfunction.Investigative ophthalmology & visual science · 2022Article
- Analysis of risk factors of rapid attenuation of graft endothelium in the early stage after penetrating keratoplasty.PloS one · 2022Article
- Eye care providers' emerging roles in early detection of diabetes and management of diabetic changes to the ocular surface: a review.BMJ open diabetes research & care · 2020Review
- DMEK outcomes using nondiabetic grafts for recipients with diabetes mellitus.American journal of ophthalmology case reports · 2019Article
- Towards Clinical Trials in Fuchs Endothelial Corneal Dystrophy: Classification and Outcome Measures-The Bowman Club Lecture 2019.BMJ open ophthalmology · 2019Review
- Diabetic corneal neuropathy: clinical perspectives.Clinical ophthalmology (Auckland, N.Z.) · 2018Review
- Risk Factors for Endothelial Decompensation after Penetrating Keratoplasty and Its Novel Therapeutic Strategies.Journal of ophthalmology · 2018Review
- Diabetic complications in the cornea.Vision research · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
objectiveTo examine the long-term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PK) in the Cornea Donor Study.
designMulticenter, prospective, double-masked, controlled clinical trial.
participantsOne thousand ninety subjects undergoing PK for a moderate risk condition, principally Fuchs' dystrophy or pseudophakic or aphakic corneal edema, were enrolled by 105 surgeons from 80 clinical sites in the United States.
methodsCorneas from donors 12 to 75 years of age were assigned by 43 eye banks to participants without respect to recipient factors. Donor and recipient diabetes status was determined from existing medical records. Images of the central endothelium were obtained before surgery (baseline) and at intervals for 10 years after surgery and were analyzed by a central image analysis reading center to determine ECD.
main outcome measuresTime to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD.
resultsThere was no statistically significant association of donor diabetes history with 10-year graft failure, baseline ECD, 10-year ECD, or ECD values longitudinally over time in unadjusted analyses, nor after adjusting for donor age and other significant covariates. The 10-year graft failure rate was 23% in the 199 patients receiving a cornea from a donor with diabetes versus 26% in the 891 patients receiving a cornea from a donor without diabetes (95% confidence interval for the difference, -10% to 6%; unadjusted P=0.60). Baseline ECD (P=0.71), 10-year ECD (P>0.99), and changes in ECD over 10 years (P=0.86) were similar comparing donor groups with and without diabetes.
conclusionsThe study results do not suggest an association between donor diabetes and PK outcome. However, the assessment of donor diabetes was imprecise and based on historical data only. The increasing frequency of diabetes in the aging population in the United States affects the donor pool. Thus, the impact of donor diabetes on long-term endothelial health after PK or endothelial keratoplasty, or both, warrants further study with more precise measures of diabetes and its complications.
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