Cornea Donor Study (CDS)
Corneal Disease, Fuch's Dystrophy, Pseudophakic Corneal Edema
About this trial
This is an interventional other trial for Corneal Disease focused on measuring cornea transplant, corneal endothelial cell density, moderate risk corneal diseases, corneal transplantation
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
Sites / Locations
- Jaeb Center for Health Research, Inc.
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
cornea assigned from donor age group <66.0 years
cornea assigned from donor age group >= 66.0 years