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

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.