Frozen versus fresh corneal graft carriers in Boston keratoprosthesis surgery: 10-year outcomes.

ABSTRACT

OBJECTIVE: To compare 10-year clinical outcomes of frozen versus fresh corneal graft carriers for the Boston Keratoprosthesis type 1 (KPro). DESIGN: Prospective, non-masked randomized controlled trial. PARTICIPANTS: Nineteen eyes of 19 patients having undergone Boston KPro type 1 implantation using a fresh or frozen graft carrier. METHODS: All patients that underwent Boston KPro type 1 implantation by a single experienced surgeon using an allograft carrier between October 2008 and March 2010 at the Centre Hospitalier de l'Université de Montréal were considered. Patients were excluded if they had a history of prior KPro implantation in the same eye. A subset of the patient cohort enrolled in the initial study protocol of 24 months continued follow-up to 120 months. Participants were randomized to receive either a fresh or frozen corneal graft carrier depending on tissue availability from the eye bank on the day of KPro implantation. RESULTS: Nineteen eyes of 19 patients were included, with 11 in the fresh group and 8 in the frozen group. At 10 years, in the fresh and frozen groups respectively, device retention was 91% and 75%; mean best corrected visual acuity increased from counting fingers preoperatively to 20/300 and 20/125; and incidence of complications per patient was 2.36 and 2.37. There were no statistically significant differences between groups for any of these outcome measures (p > 0.05 for all analyses). CONCLUSIONS: Fresh and frozen corneal graft carriers offer similar clinical outcomes for KPro implantation in terms of device retention, change in visual acuity, and rate of complications at 10 years.