N/A
N=1,090
Cornea Donor Study
Corneal Disease · Fuch's Dystrophy · Pseudophakic Corneal Edema
Bottom Line
View on ClinicalTrials.gov: NCT00006411 ↗Enrolled (actual)
1,090
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Graft Failure — 142; 82 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- corneas assigned by donor age group (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- National Eye Institute (NEI)
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Graft Failure |
142; 82 | — |
| SECONDARY Endothelial Cell Density (ECD) |
628; 550 | — |
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).
Eligibility Criteria
Inclusion
- Age range 40-80 years
- Corneal disease: Presence of a condition associated with endothelial dysfunction, including pseudophakic/aphakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, interstitial keratitis (nonherpetic) or perforating corneal injury
- Willingness to be followed for 5 years and life expectancy at least 5 years (in investigator's judgement)
Exclusion
- Patients are to be excluded when there is:
- a high risk of graft failure, including failed prior penetrating keratoplasty in the eye to be transplanted, chemical burns or other significant cicatricial conjunctivitis (ocular surface disease), herpes simplex/zoster, temporary keratoprosthesis, iridocorneal endothelial syndrome or any corneal condition in which there are two or more quadrants of stromal neovascularization
- A quadrant is considered vascularized if there is at least one patent stromal vessel >2.0 mm in length crossing the limbus within a quadrant. Two quadrants are considered vascularized if there are at least two stromal vessels 90º or more apart. Enrollment will be restricted to no more than 20% of the total cohort having stromal neovascularization.
- Patients should be excluded if there are PAS or other abnormalities that, in the view of the investigator, place the patient at high risk for graft failure.
- a very high probability of success including keratoconus, stromal dystrophies, stromal scars without edema or post-refractive surgery with healthy endothelium
- Uncontrolled glaucoma or prior filtering surgery with placement of a shunt in the eye to be grafted (Note: eyes requiring a filtering procedure combined with the PK are considered to have uncontrolled glaucoma and are ineligible. Eyes which have undergone filtering surgery (without a shunt) in which glaucoma is currently considered under control are eligible)
- Uncontrolled uveitis in the eye to be grafted
- Fellow eye visual acuity <20/200
- Fellow eye already included in the study
Data sourced from ClinicalTrials.gov (NCT00006411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.