Intracameral Enoxaparin for Descemet Membrane Endothelial Keratoplasty: A Pilot Safety Study.

Abstract

Purpose: The purpose of this study was to investigate the safety and outcomes of Descemet membrane endothelial keratoplasty (DMEK) performed with intracameral enoxaparin.

Methods: Two arms were used: a clinical multicenter retrospective cohort arm (CA) and an ex vivo basic science arm (BSA). In CA, DMEKs were performed by 6 experienced corneal surgeons at multiple sites. Intracameral enoxaparin (40 mg/500 mL) was added to the irrigation fluid for all cases. Primary outcomes were measured at 6 and 12 months. In BSA, mated graft pairs were randomized to control or enoxaparin exposure (0.8 mg/mL × 1 hour) and assessed for endothelial cell death count at 0-, 1-, and 24-hour intervals and cellular stress by ELISA Annexin V protein quantification.

Results: In the cohort arm, the mean age of 159 eyes of 134 patients was 69.3 years with Fuchs dystrophy as the primary diagnosis. Mean BCVA improved from 0.42 ± 0.3 logMAR preoperatively to 0.13 ± 0.1 logMAR postoperatively at 6 months (P  < 0.001) and to 0.1 ± 0.1 logMAR at 12 months (P < 0.001). At 6 months, 58.4% of patients achieved a final BCVA of 20/25 or better and 91% improved to 20/40 or better. Rebubble rate was 13% (n = 21), with 6 of these 21 eyes requiring more than 1 rebubble. One total graft detachment was noted with no reports of intraoperative or postoperative hemorrhage. PGF occurred in 0 of 159 eyes. In BSA, enoxaparin had no significant effect on endothelial cell death count or cellular apoptosis compared with control.

Conclusions: Enoxaparin can safely be used in DMEK surgery without apparent increased risk of intraoperative hemorrhage, graft detachment/failure, or endothelial cell toxicity.