論文

国際誌
2020年9月5日

Five-Year Follow-up of First Eleven Cases Undergoing Injection of Cultured Corneal Endothelial Cells for Corneal Endothelial Failure.

Ophthalmology
  • Kohsaku Numa
  • Kojiro Imai
  • Morio Ueno
  • Koji Kitazawa
  • Hiroshi Tanaka
  • John D Bush
  • Satoshi Teramukai
  • Naoki Okumura
  • Noriko Koizumi
  • Junji Hamuro
  • Chie Sotozono
  • Shigeru Kinoshita
  • 全て表示

128
4
開始ページ
504
終了ページ
514
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1016/j.ophtha.2020.09.002

PURPOSE: To report the safety and efficacy of a novel cell-injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term clinical data of 5-years postoperative in a 'first-in-man' clinical trial group. DESIGN: Prospective observational study. PARTICIPANTS: This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC-injection therapy between December 2013 and December 2014. METHODS: All patients underwent follow-up examinations at 1-, 4-, 12-, and 24-weeks and 1-, 2-, 3-, 4-, and 5-years postoperative. Specific corneal endothelial cell parameters [i.e., corneal endothelial cell density (ECD), coefficient of variation of area, and percentage of hexagonal cells] and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure were recorded. MAIN OUTCOME MEASURES: The primary outcome was the change of central ECD post cell-injection therapy, and the secondary outcome was corneal thickness, BCVA, and intraocular pressure during the 5-year-postoperative follow-up periods. RESULTS: At 5-years postoperative, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean central corneal ECD was 1,257 ± 467 cells/mm2 (± SD) (range, 601 to 2,067 cells/mm2), BCVA was significantly improved in 10 treated eyes, the mean logMAR VA had changed to 0.046 from that of 0.876 at prior to surgery, and no major adverse reactions directly related to the 'hCEC-injection therapy' were observed. CONCLUSIONS: The findings in this study confirmed the safety and efficacy of cultured hCEC-injection therapy for up to 5-years postoperative.

リンク情報
DOI
https://doi.org/10.1016/j.ophtha.2020.09.002
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/32898516
ID情報
  • DOI : 10.1016/j.ophtha.2020.09.002
  • PubMed ID : 32898516

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