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Corneal Stromal Transplantation With Human-derived Acellular Dermal Matrix for Pellucid Marginal Corneal Degeneration

A Nonrandomized Clinical Trial

Jiang, Xiaodan, MD1; Wang, Yuexin, MD1; Qiu, Weiqiang, MD1; Huang, Chen, MD1,2; Liu, Ziyuan, MD1; Ding, Tong, MD1; Shi, Danna, MD1; Li, Xuemin, MD1

doi: 10.1097/TP.0000000000002681
Original Clinical Science—General
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Background. To investigate the transparency, biocompatibility, and safety of human-derived acellular dermal matrix for application in corneal stromal transplantation.

Methods. Twenty-four patients (24 eyes) with pellucid marginal corneal degeneration were enrolled, and intrastromal keratoplasty was performed with human-derived acellular dermal matrix. The ocular symptoms and signs as well as graft characteristics were evaluated at baseline and at 1 day, 1 week, and 1, 3, and 6 months postoperatively. Photography by a slit lamp, topography by Pentacam, anterior segment-optical coherence tomography, and corneal confocal microscopy were conducted at baseline and during the follow-up period.

Results. Postoperative discomfort was relieved during the follow-up period. No abnormal ocular signs were observed at 6 months, indicating the safety of the procedure. Desirable and improved transparency of the grafts was demonstrated, and all the grafts healed without dissolution or fall at 6 months postoperatively. Reepithelization was completed, and confocal microscopy revealed that keratocytes and nerves repopulated in all the grafts at 6 months postoperatively. The thinning of the marginal corneal stroma was eliminated following the transplantation, and the curvature and corneal regularity remained stable at 6 months compared with baseline.

Conclusions. The present study demonstrated the transparency, biocompatibility, and safety of human-derived acellular dermis matrix in intrastromal keratoplasty. With further improvements, human-derived acellular dermis matrix could be applied in central lamellar keratoplasty and ultimately solve the shortage of donor grafts.

1 Department of Ophthalmology, Peking University Third Hospital, Beijing, China.

2 Medical Research Center, Peking University Third Hospital, Beijing, China.

Received 5 November 2018. Revision received 24 January 2019.

Accepted 8 February 2019.

The trial was registered on Chinese Clinical Trial Registry. The registration number was ChiCTR1800016050.

X.J., Y.W., and W.Q. are co-first authors.

W.Q., X.L., and X.J. were responsible for the research design and supervision. W.Q., X.L., X.J., Y.W., Z.L., T.D., and D.S. participated in performance of the research. X.J., Y.W., Z.L., T.D., and D.S. participated in acquisition of the data. X.J., Y.W., and C.H. participated in data analysis. Y.W. and C.H. were responsible for the writing of paper. All the authors participated in the revision and approval of the final version of the article.

The authors have no proprietary or financial interest in the materials used in this study and no conflicts of interest to report.

This work was supported by the Beijing Municipal Science & Technology Commission, People’s Republic, and Capital Clinical Characteristic Application Research Project (No. Z151100004015073).

The sponsor or funding organization had no role in the design or conduct of this research.

Correspondence: Dr Xuemin Li, Department of Ophthalmology, Peking University Third Hospital, 49 North Garden Road, Haidian District, 100191, Beijing, China. (13911254862@163.com).

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.