Recipient Risk Factors for Graft Failure in the Cornea Donor Study

Presented at: American Academy of Ophthalmology Annual Meeting, Atlanta, Georgia, November 2008.

Received 3 September 2008; received in revised form 20 November 2008; accepted 18 December 2008. published online 23 April 2009.

Purpose

To identify recipient factors that may be related to risk of corneal graft failure.

Design

Multicenter, prospective, double-masked, controlled clinical trial.

Participants

One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema).

Methods

Donor corneas were assigned using a random approach without respect to recipient factors, and surgeons were masked to information about the donor cornea, including donor age. Surgery and postoperative care were performed according to the surgeons' usual routines, and subjects were followed up for 5 years. Baseline factors were evaluated for their association with graft failure.

Main Outcome Measures

Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of 3 consecutive months.

Results

Preoperative diagnosis of pseudophakic or aphakic corneal edema increased graft failure risk approximately 4-fold compared with Fuchs' dystrophy (27% vs. 7%). Prior glaucoma surgery with preoperative glaucoma medication use substantially increased the graft failure rate. Factors not strongly associated with graft failure included age, gender, diabetes, smoking, and graft size.

Conclusions

The risk of graft failure is significantly increased in eyes with pseudophakic or aphakic corneal edema compared with Fuchs' dystrophy, independent of lens status, and in eyes with a history of glaucoma.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Available online: April 23, 2009.

1 W. K. Kellogg Eye Center, The University of Michigan, Ann Arbor, Michigan

2 Jaeb Center for Health Research, Tampa, Florida

3 Midwest Eye Banks, Ann Arbor, Michigan, Tampa, Florida

4 Cornea Consultants of Albany, Albany, New York

5 Michigan Cornea Consultants, PC, Southfield, Michigan

6 Virginia Mason Medical Center, Seattle, Washington

7 University of California Davis, Sacramento, California

8 Cincinnati Eye Institute, Cincinnati, Ohio

Correspondence: Alan Sugar, MD, c/o Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647

Manuscript no. 2008-1059.

A list of the members of the Cornea Donor Study Investigator Group is available at http://aaojournal.org (Ophthalmology 2008;115:620-6).

Financial Disclosure(s): The author(s) have made the following disclosure(s): Roy W. Beck received financial support from Bausch & Lomb, Inc., Katena Products, Inc., ViroMed Laboratories, Inc., Konan Medical Corp.

Supported by the National Eye Institute, Bethesda, Maryland (cooperative agreement nos.: EY12728 and EY12358); Additional support provided by Eye Bank Association of America, Washington, DC; Bausch & Lomb, Inc., Rochester, New York; Tissue Banks International, Baltimore, Maryland; Vision Share, Inc., Apex, North Carolina; San Diego Eye Bank, San Diego, California; The Cornea Society, Fairfax, Virginia; Katena Products, Inc., Denville, New Jersey; ViroMed Laboratories, Inc., Minnetonka, Minnesota; Midwest Eye-Banks (Michigan Eye-Bank, Illinois Eye-Bank), Ann Arbor, Michigan; Konan Medical Corp., Torrance, California; Eye Bank for Sight Restoration, New York, New York; SightLife, Seattle, Washington; Sight Society of Northeastern New York (Lions Eye Bank of Albany), Albany, New York; and the Lions Eye Bank of Oregon, Portland, Oregon.

PII: S0161-6420(08)01350-X

doi:10.1016/j.ophtha.2008.12.050

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