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JAMA Ophthalmol. 2017 Dec 1;135(12):1401-1409. doi: 10.1001/jamaophthalmol.2017.4989.

Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial.

Author information

1
Central Pennsylvania Eye Center, Hershey
2
Department of Ophthalmology and Visual Sciences, Case Western Reserve University, Cleveland, Ohio
3
University Hospitals Cleveland Medical Center, Cleveland, Ohio
4
Jaeb Center for Health Research, Tampa, Florida
5
Stein Eye Institute, University of California, Los Angeles
6
Michigan Cornea Consultants, Southfield
7
Cornea Associates of Texas, Dallas
8
Focal Point Vision, San Antonio, Texas
9
Mid Atlantic Cornea Consultants, Baltimore, Maryland
10
Eversight, Ann Arbor, Michigan
11
Woolfson Eye Institute, Atlanta, Georgia
12
Devers Eye Institute, Portland, Oregon
13
University of Illinois Chicago Eye and Ear Infirmary, Chicago
14
Verdier Eye Center, Grand Rapids, Michigan

Abstract

Importance:

Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool.

Objective:

To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less.

Design, Setting, and Participants:

A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy).

Interventions:

Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT).

Main Outcomes and Measures:

Graft success at 3 years.

Results:

Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; Pā€‰=ā€‰.008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (Pā€‰=ā€‰.01 [PT analyzed as categorical variable]).

Conclusions and Relevance:

The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01537393.

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