Bio-Tissue announced the results of a retrospective, case-control study, Self‑retained Cryopreserved Amniotic Membrane for Treating Severe Corneal Ulcers: A Comparative, Retrospective Control Study, published in the October 12, 2020, issue of Scientific Reports.
A total of 24 patients with central and paracentral corneal infectious ulcers and initial visual acuity (VA) worse than 20/200 participated in the study at SUNY Upstate Medical University in Syracuse, New York. All patients underwent corneal scraping and microbiological culturing followed by topical broad-spectrum antibiotics (Vancomycin 25 mg/ml and Tobramycin 15 mg/ml). Among them, 11 eyes of 11 patients received an additional placement of Bio-Tissue’s Prokera Slim Cryopreserved Amniotic Membrane (CAM).
Epithelialization and Best Corrected Snellen Visual Acuity (BCSVA) were compared between the two groups; at baseline, both groups had comparable age, gender, VA, size, and corneal ulcer location. Patients who had received the additional CAM placement had significantly faster epithelialization within 3.56 ± 1.78 weeks vs. 5.87 ± 2.20 weeks (p = 0.01). Complete epithelialization was seen in significantly more patients (72.7% vs. 23.1% P = 0.04) despite overall larger baseline defect size (32.7 ± 19.5 mm2 vs. 21.5 ± 10.7 mm2, P = 0.11). This group also had clinically significant BCSVA (> 3 lines) (81.8% vs. 38.4%, P = 0.047) and total VA improvement (log MAR 0.7 ± 0.6 vs. 1.6 ± 0.9, P = 0.016) compared to the control group during complete epithelialization.
“This study shows strong support for utilizing Prokera in conjunction with the standard of care (SOC) to promote significantly faster epithelialization and better visual acuity than SOC alone,” TissueTech co-founder and Chief Technology Officer Scheffer C.G. Tseng, MD, PhD, said in a company news release. “Prokera is FDA-cleared and contains the only cryopreserved amniotic membrane designated by the FDA as anti-inflammatory, anti-scarring, and anti-angiogenic on the ocular surface.”
Clinicians have seen that corneal ulcers disrupt the ocular surface’s integrity, resulting in further damage from mechanical friction. Many clinicians believe that CAM may serve as a safe mechanical barrier to prevent additional frictional trauma to the ocular surface while providing therapeutic benefits designated by the FDA as being anti-inflammatory and anti-scarring.
Furthermore, various studies have reported that CAM retains an antimicrobial property.1-4 If confirmed, this may suggest why the epithelialization occurred much faster in the CAM group. Additional prospective and randomized controlled studies could demonstrate the efficacy of Prokera as an adjunctive treatment for infectious corneal ulcers.
- Kjaergaard, N. et al. Antibacterial properties of human amnion and chorion in vitro. Eur. J. Obstet Gynecol. Reprod. Biol. 94, 224–229 (2001).
- Palanker, N. D. et al. Antimicrobial efficacy assessment of human derived composite amnion-chorion membrane. Sci. Rep. 9, 15600 (2019).
- Mao, Y. et al. Antimicrobial peptides secreted from human cryopreserved viable amniotic membrane contribute to its antibacterial activity. Sci. Rep. 7, 13722 (2017).
- Zare-Bidaki, M., Sadrinia, S., Erfani, S., Afkar, E. & Ghanbarzade, N. Antimicrobial properties of amniotic and chorionic membranes: a comparative study of two human fetal sacs. J. Reprod. Infertil. 18, 218–224 (2017).