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Randomized, Prospective, Single-Masked Clinical Trial of Endothelial Keratoplasty Performance With 2 Donor Cornea 4°C Storage Solutions and Associated Chambers

Price, Marianne O. PhD; Knight, O'Rese J. MD; Benetz, Beth Ann MA; Debanne, Sara M. PhD; Verdier, David D. MD; Rosenwasser, George O. MD; Rosenwasser, Miriam MS; Price, Francis W. Jr MD; Lass, Jonathan H. MD

doi: 10.1097/ICO.0000000000000354
Clinical Science
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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.

*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.

Reprints: Marianne O. Price, PhD, Cornea Research Foundation of America, 9002 N. Meridian St, Suite 212, Indianapolis, IN 46260 (e-mail: mprice@cornea.org).

Life4°C storage solution and Transcend storage chambers were kindly provided by Debra Skelnik of Numedis, Inc, to the participating eye banks. Additional support was provided by the Case Western Reserve University Department of Ophthalmology and Visual Sciences.

M. O. Price's institution has received a research grant from Baush & Lomb; the other authors have no conflicts of interest to disclose.

Received October 27, 2014

Received in revised form November 18, 2014

Accepted November 18, 2014

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