CompletedNot Applicable

Cornea Donor Study

United States1,090 participantsStarted 2000-01-10

Plain-language 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).

Who can participate

Age range40 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Patients are to be excluded when there is:
✕. 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

What they're measuring

Graft Failure

Timeframe: Baseline to 10 Years of Follow Up

Trial details

NCT IDNCT00006411

SponsorNational Eye Institute (NEI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-12-31

Results submitted2014-09-26

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