JAMA Ophthalmology Journal Club Slides: Factors Predictive of Corneal Graft Survival

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JAMA Ophthalmology Journal Club Slides:Factors Predictive of Corneal Graft Survival

Writing Committee for the Cornea Donor Study Research Group. Factors predictive of corneal graft survival in the Cornea Donor Study. JAMA Ophthalmol. Published online October 16, 2014. doi:10.1001/jamaophthalmol.2014.3923.


Introduction

• Background: The Cornea Donor Study (CDS) showed penetrating corneal graft survival of 86% at 5 years for both younger and older donors and 77% for younger donors and 71% for older donors at 10 years. There was no significant difference at 10 years except at extremes of donor age.

• Objective: To examine the effects of factors other than age and their influence on graft survival in the CDS at 10 to 12 years of follow-up.


• Study Design: Multicenter, prospective, double-masked, controlled clinical trial.

• Participants: 1090 participants with endothelial disease (62% with Fuchs dystrophy, 34% with pseudophakic or aphakic corneal edema [PACE]) undergoing penetrating keratoplasty (PKP). Corneas from donors aged <66 or ≥66 years were compared. Follow-up for graft failure was up to 12 years.

• Data Analysis: Kaplan-Meier cumulative probabilities of graft failure at 10 years were calculated. Proportional hazards regressions assessed baseline donor and recipient factor associations with graft failure. P < .01 was considered statistically significant.

• Limitations: Postoperative treatment was at surgeon discretion. Corneal thickness (CT) and endothelial cell density (ECD) were not measured on all participants.

Methods


• 663 participants with clear graft at 5 years consented to 10-year follow-up.

• Overall graft failure rate was 21% at 10 years (224 of 1090 participants).

• Failure rate was 37% in participants with PACE and 20% in those with Fuchs dystrophy (P < .001). Hazard ratio was 4.3 at 5 years, but among grafts still functioning at 5 years, hazard ratio was 1.1 for subsequent failure.

• Failure rate was 58% in participants with glaucoma surgery and using medications to lower intraocular pressure at the time of PKP vs 22% with no history of glaucoma surgery or medication use (P < .001). Hazard ratio was 7.2 at 5 years and 0.5 after 5 years.

• Trends toward increased failure rate in older recipients, smokers, and African American participants.

• No effect of eye banking parameters, history of diabetes mellitus in recipient or donor, or ABO matching.

Results


Association of Baseline Recipient Factors and

Graft Failure

Results


• Intraocular Lens (IOL) Effects

– Fuchs dystrophy: Failure rate at 10 years was 16% in phakic eyes vs 20% in pseudophakic eyes (P = .34).

– PACE: Failure rate was 57% in eyes with anterior chamber IOL vs 30% in eyes with posterior chamber IOL (P = .02). Hazard ratio was 1.9 at 5 and 10 years.

– At 10 years, eyes with an anterior chamber IOL retained at PKP had a 59% graft failure rate, whereas eyes with an anterior chamber IOL exchanged for a posterior chamber IOL had a 23% failure rate (P = .04).

Results


Association of Lens Status and Graft Failure According to Corneal Diagnosis

Results


• ECD and CT– No effect of donor ECD (2300-3300 cells/mm2).– Failure rates by ECD and CT:

Results

Follow-up Factor at 5 y 10-Year Graft Failure Rate, % P Value

ECD, cells/mm2

<500 29

<.001 500-1499 10

≥1500 2

CT, μm

<600 8

<.001 600-646 19

≥650 34


Graft Failure Rates Over Time Stratified by 5-Year

ECD and CT Values

Results


• Similar associations between baseline recipient factors and graft failure at both 5 and 10-12 years.

• Failure rate was greater in participants with PACE than those with Fuchs dystrophy.

• Increased hazard of PACE and preoperative glaucoma for first 5 years but not thereafter, apparently due to early failure of grafts in eyes treated for glaucoma and eyes in which continued IOL effects were cause of PACE.

• Both thicker grafts and lower ECD are predictive of failure.

• Most grafts with low ECD (<500 cells/mm²) at 5 years survived to 10 years (71%).

• Since the CDS, there has been a shift from PKP to endothelial keratoplasty.

• Applicability of CDS findings to endothelial keratoplasty cannot be predicted.

Comment


Contact Information• If you have questions, please contact the corresponding author:

– Alan Sugar, MD, c/o CDS Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647 ([email protected]).

Funding/Support• This study was supported by cooperative agreements EY12728 and EY12358 with the

National Eye Institute and by the Eye Bank Association of America, Bausch & Lomb, Inc, Tissue Banks International, Vision Share, Inc, San Diego Eye Bank, The Cornea Society, Katena Products, Inc, ViroMed Laboratories, Inc, Midwest Eye Bank (Michigan Eye Bank, Illinois Eye Bank, Cleveland Eye Bank, and Lions Eye Bank of New Jersey), Konan Medical Corp, Eye Bank for Sight Restoration, SightLife, Sight Society of Northeastern New York (Lions Eye Bank of Albany), and Lions Eye Bank of Oregon.

Conflict of Interest Disclosures• None reported.

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JAMA Ophthalmology Journal Club Slides: Factors Predictive of Corneal Graft Survival