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Cornea. 2015 Mar;34(3):253-6. doi: 10.1097/ICO.0000000000000354.

Randomized, prospective, single-masked clinical trial of endothelial keratoplasty performance with 2 donor cornea 4°C storage solutions and associated chambers.

Author information

1
*Cornea Research Foundation of America, Indianapolis, IN; †Case Western Reserve University Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, OH; ‡Department of Epidemiology and Biostatistics, Case Western Reserve University, Cleveland, OH; §Verdier Eye Center, Grand Rapids, MI; ¶Central Pennsylvania Eye Institute, Hershey, PA; and ‖Price Vision Group, Indianapolis, IN.

Abstract

PURPOSE:

The aim of this study was to compare endothelial cell loss and graft success 6 months after endothelial keratoplasty (EK) with paired donor corneas stored in Optisol GS and Life4°C solutions and their associated storage chambers.

METHODS:

Donor pairs were stored, one in Optisol GS and the other in Life4°C, and prepared for Descemet stripping automated EK or Descemet membrane EK. Matched pairs of recipients with Fuchs dystrophy were randomized to 1 member of each donor pair. Clarity of recipient stroma, intraocular pressure, and complications were followed for 6 months. Central endothelial images of the donor cornea at screening and 3 and 6 months after EK were analyzed by a masked central reading center. Dual grading of endothelial cell density was performed using the center method. Differences in endothelial cell density and cell loss were examined by paired analysis.

RESULTS:

Thirty-two pairs were enrolled, and 27 were analyzed (5 had improper matching or loss to follow-up). Donor age was 59 ± 14 years, median death-to-surgery time was 4 days (range, 2-9 days), 6 recipient pairs had Descemet membrane EK, and 21 had Descemet stripping automated EK. Recipient age was comparable in the Optisol GS and Life4°C groups (70 vs. 68 years, respectively, P = 0.46). Six-month central endothelial cell loss did not differ significantly between the Life4°C and Optisol GS groups (18 ± 18% vs. 20 ± 20%, respectively, P = 0.55). All recipient corneas were clear at 6 months in both groups.

CONCLUSIONS:

Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4°C.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657500.

PMID:
25625366
DOI:
10.1097/ICO.0000000000000354
[Indexed for MEDLINE]

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