Shelf-Stable, Cryopreserved Amniotic Membrane for the Management of Ocular Surface Disease: A Retrospective Assessment

Clin Optom (Auckl). 2025 Dec 21:17:409-415. doi: 10.2147/OPTO.S563708. eCollection 2025.

Abstract

Purpose: To assess both the short- and long-term clinical outcomes following adjunctive treatment with shelf-stable, cryopreserved amniotic membrane (CAM) in patients with ocular surface disease (OSD).

Methods: This was a single-center, retrospective study of consecutive patients with OSD that underwent adjunctive treatment with shelf-stable CAM with 72-hour collagen shield or bandage contact lens followed by partial tape tarsorrhaphy at a single-center between January 2024 and March 2025. Corneal staining, symptoms, visual acuity (VA), and improvements in corneal sensitivity were assessed at 1 week (± 5 days) and last follow-up (12-24 weeks). Symptomatic improvement was defined as the resolution of at least one pre-treatment symptom at follow-up.

Results: A total of 29 eyes of 20 patients (mean age of 66.3 ± 9.1 years) with dry eye disease (n=14), neurotrophic keratopathy (n=5), and superficial punctate keratitis (n=10) were included in this study. At 3.9±2.9 days post-CAM placement, mean corneal staining score improved from 2.26±1.07 to 1.00± 0.91 (p<0.001), with 84.6% of eyes demonstrating improvement (mean change: 1.59 ± 0.77). Symptomatic improvement was observed in 92.3% of eyes. At 16.0 ± 2.8 weeks post-CAM, corneal staining significantly improved to 1.55 ± 1.13 (p=0.014). Trace or complete resolution of corneal staining was noted in 5/20 eyes (25.0%), and 12 eyes (60.0%) had improved staining. Symptomatic improvement was noted in 65.0% of eyes. There were no complications aside from two cases that noted irritation with collagen shield use and one case of irritation on the outer lid, which was attributed to the adhesive tape.

Conclusion: This preliminary data suggest that shelf-stable CAM may reduce both signs and symptoms of OSD as soon as four days post-treatment, with a lasting benefit observed for up to four months on average in some patients.

Keywords: amniotic membrane; dry eye disease; neurotrophic keratitis; ocular surface disease; superficial punctate keratopathy.