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C. Sotozono, T. Nakamura, T. Inatomi, J. Hamuro, Y. Satake, J. Shimazaki, K. Tsubota, Y. Hara, Y. Ohashi, S. Kinoshita; Multicenter Prospective Analysis of Cultured Corneal Epithelial Sheet Transplantation. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1519.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate a method for transporting cultivated corneal epithelial sheets, and to compare the efficacy of cultured corneal epithelial sheet transplantation performed at 3 centers using epithelial sheets prepared at one center.
Between February 2004 and July 2006, 18 patients with severe limbal stem cell deficiency were enrolled in a multicenter study in Japan. The cases consisted of Stevens-Johnson syndrome (8), ocular pemphigoid (2), aniridia (2), unknown cause (3), and others (3). The number of the cases was 8 in Kyoto Prefectural University of Medicine (KPUM), 6 in Tokyo Dental College (TDC), and 4 in Ehime University (EU). Cultivated corneal epithelial sheets were prepared at KPUM in Kyoto, then put into a chamber containing culture medium. That chamber was then put into a thermos and transported by car for 15-18 hours from KPUM to TDC or EU while maintaining a temperature of approximately 37°C inside the thermos. Soon after the arrival, the corneal epithelial sheets were re-cultured in medium at 37°C for 12-24 hours before the operation. Transplantation and postoperative treatment were conducted according to the protocol determined previously. Best-corrected visual acuity (BCVA) before and at the postoperative sixth month were evaluated. The grade of hyperemia, symblepharon, epithelial defect, conjunctivalization, neovascularization, and opacification was scored and compared between KPUM and the other 2 centers. Data on adverse outcomes were also collected.
The epithelial sheets were not damaged histologically, and at the beginning of transplantation there was no epithelial defect in all cases. Six months after surgery, BCVA was improved in 14 cases and had worsened in 1 case. Total scores of hyperemia, symblepharon formation, conjunctivalization, neovascularization, and opacification improved after transplantation in all cases except one. There were no significant differences in the results between KPUM and the other 2 centers. No adverse outcomes such as rejection, infection, or glaucoma occurred.
We established a safe and reliable method for transporting cultivated corneal epithelial sheets. We obtained favorable results both in cases that used transported corneal epithelial sheets, as well as in cases without transported sheets. Postoperative follow-up showed that our protocol is valid and useful for the treatment of severe LSCD.
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