@article {1661818,
	title = {Prospective, Randomized, Multicenter, Double-Masked, Clinical Trial of Corneal Cross-Linking for Boston Keratoprosthesis Carrier Tissue},
	journal = {Am J Ophthalmol},
	volume = {249},
	year = {2023},
	month = {2023 May},
	pages = {39-48},
	abstract = {PURPOSE: To assess whether cross-linking the carrier donor cornea of the Boston Keratoprosthesis (BKPro) improves retention of the device in participants at high risk for keratolysis. DESIGN: Prospective, double-masked, randomized clinical trial. METHODS: In this multicenter study, 68 adult participants who were scheduled for BKPro implantation were enrolled. Masked participants were randomized to receive either a cross-linked (CXL) or non-cross-linked (non-CXL) donor corneal carrier. The Kaplan-Meier event-free survival was determined by the product-limit method and compared by the log-rank test to examine whether survival curves were different between the CXL and non-CXL groups. The primary outcome of the study was time from surgery to BKPro removal. The secondary endpoint was 12-month retention rate. RESULTS: A total of 68 participants were enrolled and randomized 1:1 to each group. The average age at the time of surgery was 62 (range\&nbsp;=\&nbsp;24-89) years, and 42 participants (62\%) were male. The overall BKPro retention rate was 70\% during a mean follow-up time of 93 (range\&nbsp;=\&nbsp;6-201) weeks. Twenty BKPros were removed, 10 in the CXL group and 10 in the non-CXL group, with 18 requiring removal because of sterile keratolysis. There was no difference in the time to removal between the groups during the study (P\&nbsp;=\&nbsp;.910). At 12 months, there was no significant difference in the retention rate in the CXL group (94\%) vs the non-CXL group (82\%, P\&nbsp;=\&nbsp;.150). CONCLUSIONS: In this prospective study, cross-linking of the carrier cornea prior to BKPro implantation did not reduce the incidence of sterile keratolysis or increase device retention among participants at high risk for retention failure.},
	keywords = {Adult, Aged, Aged, 80 and over, Cornea, Corneal Cross-Linking, Corneal Diseases, Cross-Linking Reagents, Female, Humans, Keratoconus, Male, Middle Aged, Photosensitizing Agents, Prospective Studies, Prostheses and Implants, Riboflavin, Ultraviolet Rays, Young Adult},
	issn = {1879-1891},
	doi = {10.1016/j.ajo.2022.12.017},
	author = {De Arrigunaga, Sofia and Akpek, Esen K and Aldave, Anthony J and Mian, Shahzad I and Zurakowski, David and Ciolino, Joseph B and Boston Keratoprosthesis Cross-linking Study Group}
}
