Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study

Jonathan H Lass, Ryan J Bailey, Loretta B Szczotka-Flynn, Beth Ann Benetz, Mark Soper, Michael S Titus, Craig Kollman, Roy W Beck, Cornea Preservation Time Study Group, Jonathan H Lass, Ryan J Bailey, Loretta B Szczotka-Flynn, Beth Ann Benetz, Mark Soper, Michael S Titus, Craig Kollman, Roy W Beck, Cornea Preservation Time Study Group

Abstract

Purpose: The purpose of this study was to evaluate outcomes of Descemet stripping automated endothelial keratoplasty comparing exchange with fresh intermediate-term cold storage solution after lenticule preparation versus reuse of the original solution in the Cornea Preservation Time Study.

Methods: In the Cornea Preservation Time Study, 508 donor corneas had lenticules prepared by the eye bank with fresh solution exchange (Fresh group) and 283 with reuse of the original solution (Original group). Storage time for all donors was ≤11 days. Graft success rates, central endothelial cell loss at 3 years, and frequency of positive donor rim cultures were compared between the 2 groups.

Results: The 3-year graft success rate (95% confidence interval) was 93.4% (90.7%-95.3%) in the Fresh group and 95.2% (91.8%-97.2%) in the Original group (adjusted hazard ratio for graft failure = 0.64, 95% confidence interval, 0.33-1.24, P = 0.19). The mean percentage endothelial cell loss was significantly greater in the Fresh group versus Original group (45% ± 22% vs. 38% ± 20%, respectively, P = 0.004). Cultures were positive in 4 (1.5%) of 267 donor rims (3 fungal and 1 bacterial) in the Fresh group and in 4 (2.5%) of 158 in the Original group ( P = 0.57). There were 2 postoperative infections in the Original group and none in the Fresh group.

Conclusions: The use of the original intermediate-term cold storage solution did not reduce the 3-year graft success rate compared with exchanging with fresh solution after lenticule preparation for Descemet stripping automated endothelial keratoplasty, while the frequency of positive donor rim cultures did not significantly differ between groups.

Trial registration: ClinicalTrials.gov NCT01537393.

Conflict of interest statement

The following authors have financial disclosures with companies that manufacture corneal storage solutions (considered relevant to this work): M. Terry (Bausch & Lomb) and W. B. Lee (Bausch & Lomb) (part of CPTS Study Group but not authors on this paper). These authors are employed by eye banks: M. Soper (VisionFirst), and M. S. Titus (Eversight). J. H. Lass is a voluntary board member of Eversight and the Cleveland Eye Bank Foundation. The remaining authors have no conflicts of interest to disclose.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1.
FIGURE 1.
Kaplan-Meier estimates of graft success during the 3-years post-surgery by storage solution procedure type (Fresh [n = 508] and Original [n = 283]). The probability of graft success at 3 years post-surgery was 93.4% (90.7%, 95.3%) in the Fresh group and 95.2% (91.8%, 97.2%) in the Original group. The inset shows the same data on a truncated vertical axis.

References

    1. Lass JH, Szczotka-Flynn LB, Ayala AR, et al. ; Writing Committee for the Cornea Preservation Time Study Group. Cornea Preservation Time Study: methods and potential impact on the cornea donor pool in the United States. Cornea. 2015;34:601–608.
    1. Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, et al. ; Cornea Preservation Time Study Group. Effect of cornea preservation time on success of Descemet stripping automated endothelial keratoplasty: a randomized clinical trial. JAMA Ophthalmol. 2017;135:1401–1409.
    1. Eye Bank Association of America. 2021 Eye Banking Statistical Report. Washington DC. 2022. Available at: . Accessed April 29, 2022.
    1. Wahlberg D. Available at: . Accessed April 29, 2022.
    1. Erickson K. Imported EusolC to Fill the Gap Created by Optisol Shortage. Available at: . Accessed April 29, 2022.
    1. Lass JH, Benetz BA, Verdier DD, et al. ; Cornea Preservation Time Study Group. Corneal endothelial cell loss 3 years after successful Descemet stripping automated endothelial keratoplasty in the Cornea Preservation Time Study: a randomized clinical trial. JAMA Ophthalmol. 2017;135:1394–1400.
    1. Mian SI, Aldave AJ, Tu EY, et al. . Incidence and outcomes of positive donor rim cultures and infections in the Cornea Preservation Time Study. Cornea. 2018;37:1102–1109.
    1. Benetz BA, Stoeger CG, Patel SV, et al. ; Cornea Preservation Time Study Group. Comparison of donor cornea endothelial cell density determined by eye banks and by a central reading center in the Cornea Preservation Time Study. Cornea. 2019;38:426–432.
    1. Benetz BA, Gal RL, Rice C, et al. . Dual grading methods by a central reading center for corneal endothelial image quality assessment and cell density determination in the Specular Microscopy Ancillary Study of the Cornea Donor Study. Curr Eye Res. 2006;31:1–9.
    1. Lindstrom RL, Kaufman HE, Skelnik DL, et al. . Optisol corneal storage medium. Am J Ophthalmol. 1992;114:345–356.
    1. Lass JH, Gordon JF, Sugar A, et al. . Optisol containing streptomycin. Am J Ophthalmol. 1993;116:503–504.
    1. Price MO, Knight OJ, Benetz BA, et al. . Randomized, prospective, single-masked clinical trial of endothelial keratoplasty performance with 2 donor cornea 4°C storage solutions and associated chambers. Cornea. 2015;34:253–256.
    1. Kanavi MR, Javadi MA, Chamani T, et al. . Comparing quantitative and qualitative indices of the donated corneas maintained in Optisol-GS with those kept in Eusol-C. Cell Tissue Bank. 2015;16:243–247.
    1. Price MO, Feng MT, Price FW, Jr. Endothelial keratoplasty update 2020. Cornea. 2021;40:541–547.
    1. Eye Bank Association of America. Medical Standards. Washington, DC: 2021. Available at: . Accessed April 29, 2022.
    1. Eye Bank Association of America. Procedures Manual. Washington, DC: 2021. Available at: . Accessed April 29, 2022.
    1. Alchimia 510k Approval for Eusol-C by the FDA. Available at: . Accessed April 29, 2022.
    1. Baush and Lomb 510k Approval of Optisol GS by the FDA. Available at: . Accessed April 29, 2022.
    1. Numedis 510k Approval of Life 4C by the FDA. Available at: . Accessed April 29, 2022.
    1. Writing Committee for the Cornea Donor Study Research Group; Holland EJ, Dontchev M, Dontchev M, et al. . The effect of donor age on penetrating keratoplasty for endothelial disease: graft survival after 10 years in the Cornea Donor Study. Ophthalmology. 2013;120:2419–2427.
    1. Cornea Donor Study Investigator Group; Gal RL, Beck RW, Beck RW, et al. . Donor age and corneal endothelial cell loss 5 years after successful` corneal transplantation. Specular Microscopy Ancillary Study results. Ophthalmology. 2008;115:627–632.e8.
    1. Lass JH, Benetz BA, Patel SV, et al. ; Cornea Preservation Time Study Group. Donor, recipient, and operative factors associated with increased endothelial cell loss in the Cornea Preservation Time Study. JAMA Ophthalmol. 2019;137:185–193.
    1. Terry MA, Aldave AJ, Szczotka-Flynn LB, et al. ; Cornea Preservation Time Study Group. Donor, recipient, and operative factors associated with graft success in the Cornea Preservation Time Study. Ophthalmology. 2018;125:1700–1709.
    1. Wagoner MD, Gonnah ES. Corneal graft survival after prolonged storage in Optisol-GS. Cornea. 2005;24:976–979.
    1. Terry MA, Shamie N, Straiko MD, et al. . Endothelial keratoplasty: the relationship between donor tissue storage time and donor endothelial survival. Ophthalmology. 2011;118:36–40.
    1. Price MO, Fairchild KM, Price DA, et al. . Descemet's stripping endothelial keratoplasty five-year graft survival and endothelial cell loss. Ophthalmology. 2011;118:725–729.
    1. Lee WB, Jacobs DS, Musch DC, et al. . Descemet's stripping endothelial keratoplasty: safety and outcomes: a report by the American Academy of Ophthalmology. Ophthalmology. 2009;116:1818–1830.
    1. Price MO, Gorovoy M, Price FW, Jr, et al. . Descemet's stripping automated endothelial keratoplasty: three-year graft and endothelial cell survival compared with penetrating keratoplasty. Ophthalmology. 2013;120:246–251.
    1. Price DA, Kelley M, Price FW, Jr, et al. . Five-year graft survival of Descemet membrane endothelial keratoplasty (EK) versus Descemet stripping EK and the effect of donor sex matching. Ophthalmology. 2018;125:1508–1514.
    1. Newman LR, DeMill DL, Zeidenweber DA, et al. . Preloaded Descemet membrane endothelial keratoplasty donor tissue: surgical technique and early clinical results. Cornea. 2018;37:981–986.
    1. Aldave AJ. Role of antifungal prophylaxis after receipt of a positive donor rim fungal culture: the case for treatment. Cornea. 2021;40:1093–1095.
    1. Vislisel JM, Goins KM, Wagoner MD, et al. . Incidence and outcomes of positive donor corneoscleral rim fungal cultures after keratoplasty. Ophthalmology. 2017;124:36–42.
    1. Mathes KJ, Tran KD, Mayko ZM, et al. . Reports of post-keratoplasty infections for eye bank-prepared and non-eye bank-prepared corneas: 12 years of data from a single eye bank. Cornea. 2019;38:263–267.
    1. Edelstein SL, DeMatteo J, Stoeger CG, et al. . Report of the eye bank association of America medical review subcommittee on adverse reactions reported from 2007 to 2014. Cornea. 2016;35:917–926.
    1. O'Brien RC, Ishwaran H, Szczotka-Flynn LB, et al. ; Cornea Preservation Time Study Group. Random survival forests analysis of intraoperative complications as predictors of Descemet stripping automated endothelial keratoplasty graft failure in the Cornea Preservation Time Study. JAMA Ophthalmol. 2021;139:191–197.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren