At a glance
ClinicalIndex Comparison Record- ✓Age 40–80 years at enrollment.
- ✓Corneal disease with endothelial dysfunction: pseudophakic/aphakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, nonherpetic interstitial keratitis, or perforating corneal injury.
- ✓Willingness to undergo 5-year follow-up with life expectancy of at least 5 years (investigator judgment).
- ✕Prior failed penetrating keratoplasty in the eye to be grafted.
- ✕Chemical burns or significant cicatricial conjunctivitis (ocular surface disease).
- ✕Herpes simplex or zoster infection.
- ✕Corneal stromal neovascularization in ≥2 quadrants (vascularized quadrants defined as ≥1 stromal vessel >2.0 mm crossing limbus per quadrant, or ≥2 vessels ≥90° apart). Maximum 20% of cohort may have any stromal neovascularization.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cornea Donor Study: The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease
In Brief
A clinical study evaluating corneas assigned by donor age group for Corneal Disease and 2 related conditions. Completed, enrolled 1,090 participants across 1 site.
Detailed Summary
The Cornea Donor Study (CDS) was designed as a prospective cohort study with the following objectives: To determine whether the graft-failure rate over a 5-year follow-up period following corneal transplantation is the same when using corneal tissue from donors older than 65 years of age compared with tissue from younger donors. To assess the relationship between donor/recipient ABO blood type compatibility and graft failure due to rejection. To assess corneal endothelial cell density as an indicator of the health of the cornea and as a alternate outcome measure (in an optional Specular Microscopy Ancillary Study).
Study Details
Timeline
Interventions
A web-based computer program was used to select and assign a cornea by donor age group from those available at the eye bank that met the study eligibility criteria. The program randomly selected a cornea based on a two-level minimization procedure which attempted first to balance for each surgeon the number of corneas from donors \>=66 and \<66 years old and then, when possible, to balance among age subgroups of 10-35, 36-50, 51-65, 66-70, and 71-75 years. The assignment was made without regard to recipient age or any other subject characteristics.