PURPOSE: This study aims to determine whether frozen corneas can be successfully used as carriers of the Boston keratoprosthesis (KPro). METHODS: Prospective study of 37 patients undergoing KPro surgery with fresh or frozen corneas as carriers. Patients were randomized to receive either a fresh corneal graft or a frozen corneal graft during implantation of the Boston KPro. The randomization depended on availability of fresh versus frozen corneas offered by the local eye bank. All surgeries were performed by the same experienced surgeon. Outcome measures included retention of the device, level of preoperative and postoperative visual acuities (VAs), and complications. RESULTS: The indication for Boston KPro was corneal graft failure in 24 eyes; 13 patients had KPro as a primary procedure. The assembly of the Boston KPro and surgery were uneventful in all cases. Mean follow-up was 9.65 months. Median preoperative VA was counting fingers (range, 20/100 to light perception) in the fresh cornea group (19 eyes) and hand motions (range, 20/150 to light perception) in the frozen cornea group (18 eyes). Median postoperative VA were 20/150 (range, 20/30 to hand motions) and 20/150 (range, 20/40 to counting fingers) in the fresh and frozen cornea groups, respectively. Inflammation and retroprosthetic membrane formation were the most common complications with similar rates between the 2 groups. The device retention rate was 100% at the end of the follow-up period. CONCLUSIONS: Frozen and fresh corneal donors seem equally efficient and safe as carriers of the Boston KPro with similar recuperation of VA and no untoward complications, such as melt, leaks, or endophthalmitis.
RCT Entities:
PURPOSE: This study aims to determine whether frozen corneas can be successfully used as carriers of the Boston keratoprosthesis (KPro). METHODS: Prospective study of 37 patients undergoing KPro surgery with fresh or frozen corneas as carriers. Patients were randomized to receive either a fresh corneal graft or a frozen corneal graft during implantation of the Boston KPro. The randomization depended on availability of fresh versus frozen corneas offered by the local eye bank. All surgeries were performed by the same experienced surgeon. Outcome measures included retention of the device, level of preoperative and postoperative visual acuities (VAs), and complications. RESULTS: The indication for Boston KPro was corneal graft failure in 24 eyes; 13 patients had KPro as a primary procedure. The assembly of the Boston KPro and surgery were uneventful in all cases. Mean follow-up was 9.65 months. Median preoperative VA was counting fingers (range, 20/100 to light perception) in the fresh cornea group (19 eyes) and hand motions (range, 20/150 to light perception) in the frozen cornea group (18 eyes). Median postoperative VA were 20/150 (range, 20/30 to hand motions) and 20/150 (range, 20/40 to counting fingers) in the fresh and frozen cornea groups, respectively. Inflammation and retroprosthetic membrane formation were the most common complications with similar rates between the 2 groups. The device retention rate was 100% at the end of the follow-up period. CONCLUSIONS: Frozen and fresh corneal donors seem equally efficient and safe as carriers of the Boston KPro with similar recuperation of VA and no untoward complications, such as melt, leaks, or endophthalmitis.
Authors: Samer N Arafat; Marie-Claude Robert; Anita N Shukla; Claes H Dohlman; James Chodosh; Joseph B Ciolino Journal: Cornea Date: 2014-09 Impact factor: 2.651