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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

Authors :
OʼRese J. Knight
David D. Verdier
Marianne O. Price
Francis W. Price
Jonathan H. Lass
Miriam Rosenwasser
Sara M. Debanne
George O D Rosenwasser
Beth Ann Benetz
Source :
Cornea. 34:253-256
Publication Year :
2015
Publisher :
Ovid Technologies (Wolters Kluwer Health), 2015.

Abstract

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.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.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.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.

Details

ISSN :
02773740
Volume :
34
Database :
OpenAIRE
Journal :
Cornea
Accession number :
edsair.doi.dedup.....660289c9f924aed53dc18d14e9afd1bd
Full Text :
https://doi.org/10.1097/ico.0000000000000354