Adjunctive Cryopreserved Amniotic Membrane for Recalcitrant Keratopathy: Long-Term Outcomes with Maintenance Therapy.

PURPOSE: Shelf-stable, cryopreserved amniotic membrane (AM) has anti-inflammatory and anti-scarring properties and clinically has been shown to promote corneal epithelialization with benefits reported up to 3 months. Herein, we assessed the long-term outcomes after treatment with AM in patients with recalcitrant keratopathy. PATIENTS AND METHODS: A single-center, retrospective review was performed of consecutive recalcitrant keratopathy patients that received treatment with shelf-stable cryopreserved AM and had at least 6-month outcomes. Corneal staining, corneal sensitivity, tear osmolarity, symptoms, concomitant treatments, and complications were assessed before treatment and up to last follow-up visit. RESULTS: A total of 33 eyes of 17 subjects that had recalcitrant keratopathy despite use of prior treatment were included in the analysis. After treatment with shelf-stable AM, corneal staining score significantly improved by a mean of 1.34 ± 0.9 at 1 week (p<0.001), 1.04 ± 0.8 at 1 month (p<0.001), 1.13 ± 0.7 at 6 months (p<0.001), 1.17 ± 0.7 at 12 months (p<0.001) and 1.10 ± 0.7 at 15 months (p<0.001). The proportion of subjects with improved corneal staining compared to baseline was 81.8% at 1 week, 72.0% at 1 month, 81.5% at 6 months, 86.2% at 12 months and 90.0% at 15 months. Improvements in corneal sensitivity were also observed, while tear osmolarity remained relatively unchanged. Despite initial improvement, symptoms gradually returned over time, coinciding with increased use of concomitant topical therapies. No complications related to the AM were observed. CONCLUSION: Recalcitrant keratopathy patients had significantly improved corneal epithelialization within 1 week of treatment with shelf-stable cryopreserved AM, which persisted in the majority of patients for up to 15 months with concomitant topical treatment.