Therapeutic Outcomes of Shelf-Stable, Cryopreserved Amniotic Membrane in Recalcitrant Keratopathy

Keratopathy can be caused by multiple factors including neuropathy, inflammation, radiation, among others. Amniotic membrane (AM) is known to have anti-inflammatory and anti-scarring properties, which helps promote epithelialization. Herein, we assessed application of AM to promote epithelialization in the treatment of recalcitrant keratopathy.

A single-center, retrospective review was performed of consecutive patients with recalcitrant keratopathy that failed to respond to conservative treatment who were subsequently treated with shelf-stable cryopreserved AM. Corneal staining, corneal sensitivity, tear osmolarity, uncorrected visual acuity (UCVA), and complications were assessed before treatment as well as one-week, one-month, and three-months post-treatment.

A total of 34 eyes of 18 subjects were included in the analysis. All eyes were diagnosed with recalcitrant keratopathy (n=34), of which 7 (20.6%) eyes had reduced corneal sensation. Eyes were treated with shelf-stable AM for an average of 2.0 ± 0.6 days. Corneal staining scores significantly improved from 1.52 ± 0.68 at baseline to 0.50 ± 0.85 at 1 week (p=0.01), 0.25 ± 0.43 at 1 month (p<0.001), and 0.47 ± 0.91 at 3 months (p=0.007). The percentage of eyes with no corneal staining was 70.0% at 1-week, 72.7% at 1-month, and 73.7% at 3-months. Corneal sensitivity improved from 2.3 ± 1.4 at baseline to 1.6 ± 0.9 at 1 week (p=0.31), 1.38 ± 0.7 at 1 month (p<0.001), and 1.11 ± 0.32 at 3 months (p=0.002). UCVA changed from 0.24 ± 0.26 at baseline to 0.14 ± 0.16 at 1 week (p=0.41), 0.18 ± 0.23 at 1 month (p=0.013), and 0.11 ± 0.08 at 3 months (p=0.08). Tear osmolarity did not significantly change from baseline at any timepoint. No complications or adverse events were noted.

Shelf-stable cryopreserved AM transplantation led to a significant improvement in corneal epithelization, corneal sensitivity, and visual acuity in patients with recalcitrant keratopathy.