Risk factors for the development of retroprosthetic membranes with Boston keratoprosthesis type 1: multicenter study results

Abstract

Objective: The purpose of this study was to identify possible risk factors for retroprosthetic membrane (RPM) development in a large, multicenter cohort of patients receiving a Boston type 1 keratoprosthesis.

Design: Cohort study.

Participants: The final analysis included 265 eyes of 265 patients who underwent implantation of a Boston keratoprosthesis type I device between January 2003 and July 2008 by 1 of 19 surgeons at 18 medical centers.

Methods: Forms reporting preoperative, intraoperative, and postoperative parameters were prospectively collected and subsequently analyzed at a central data collection site.

Main outcome measures: The primary outcome was the presence or absence of an RPM during the follow-up period.

Results: The average age of patients was 63.3±19.1 years, 48.5% of the patients were female, and 52.5% of procedures were performed on the right eye. The mean follow-up time was 17.8±14.9 months. The majority (85.4%; n = 222) had undergone an average of 2.2±1.2 (range, 1-8) penetrating keratoplasties before keratoprosthesis implantation, and 38 eyes (14.6%) received a primary keratoprosthesis. The overall RPM formation rate was 31.7% (n = 84). The most significant risk factor for RPM development was infectious keratitis (as a surgical indication for keratoprosthesis surgery itself), resulting in a rate of RPM formation of 70.6%. As an independent risk factor, the hazard ratio (HR) of RPM development in these eyes was 3.20 (95% confidence interval, 1.66-6.17). Aniridia was also an independent risk factor for RPM development (HR, 3.13; 95% confidence interval, 1.10-8.89).

Conclusions: Formation of RPM is a common complication of keratoprosthesis surgery, occurring in approximately one-third of cases. Eyes at the highest risk of RPM development are those receiving corneal replacement for infectious keratitis and aniridia.

Figure 1

Kaplan-Meier curve of time to development of retroprosthetic membrane (RPM) in patients undergoing implantation of a Boston keratoprosthesis type 1.

Figure 2

Kaplan-Meier curves of time to development of retroprosthetic membrane (RPM) comparing eyes treated with intracameral steroid intra-operatively (red) compared to those not receiving steroid (blue). The time to development of RPM is faster in eyes that did not receive intracameral steroids (p=0.041).