Prospective, Randomized, Multicenter, Double-Masked, Clinical Trial of Corneal Cross-Linking for Boston Keratoprosthesis Carrier Tissue - 13/04/23
for the
Boston Keratoprosthesis Cross-linking Study Group⁎
Résumé |
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 = 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 = 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 = .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 = .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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Keratolysis is one of the main causes of Boston Keratoprosthesis loss. |
• | Cross-linking has been shown to confer resistance to degradation by collagenases. |
• | This prospective randomized trial evaluated cross-linking of the carrier donor tissue. |
• | All participants were at increased risk for developing keratolysis. |
• | Cross-linking did not reduce the incidence of keratolysis or increase device retention. |
Plan
| Supplemental Material available at AJO.com. Parts of the data in the manuscript were previously presented at the Cornea and Eye Banking Forum 2021. |
Vol 249
P. 39-48 - mai 2023 Retour au numéro
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