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Vincent Palladino, Nicole Fuerst, Ilaria Macchi, Stephen Orlin, Mina Massaro-Giordano, Michael Sulewski, Vatinee Y Bunya; The use of ProKera® for the Treatment of Patients with Sjögren's Syndrome or Graft-versus-Host Disease.. Invest. Ophthalmol. Vis. Sci. 2017;58(8):3927.
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To determine if there are improvements in signs and symptoms of ocular surface disease after placement of a self-retained amniotic membrane (ProKera® (Bio-Tissue®)) in patients with Sjögren’s Syndrome (SS) or graft-versus-host disease (GVHD).
A retrospective cohort study of all patients with a diagnosis of either SS or GVHD who received a ProKera® Slim or ProKera® (Bio-Tissue®) implant for the treatment of ocular surface disease between August 2012 and August 2016 at a single large academic institution was performed. Twelve eyes from twelve subjects were included (6 SS, 6 GVHD). Visual acuity, fluorescein staining of the cornea, lissamine green conjunctival staining, and dry eye symptoms before and after ProKera® insertion were evaluated.
The mean age of our study sample was 58.6 years (range: 40-86 years), with a mean follow-up period of 82 days. Visual acuity improved in 50% of patients (4 GVHD subjects; 2 SS subjects). The average VA across all subjects improved by 1.0 lines on the Snellen chart. In the SS group, all patients (n=6) saw some improvement in symptoms with ProKera® compared to 67% (4/6) in the GVHD group. The majority of patients (2 GVHD; 5 SS) showed improved corneal fluorescein staining, with an average improvement of 25% (0-3 scale) across all subjects. Most patients (6 SS; 3 GVHD) also had improvements in lissamine green conjunctival staining after ProKera® implantation with an average improvement of 23% (0-4 scale) across all subjects. The ProKera® device was generally well-tolerated with only one patient discontinuing use due to foreign body sensation. Recurrence of ocular surface symptoms was observed in three subjects at 1 month, 2 months, and 5 months.
In this small series, ProKera® implantation was found to be easy-to-use, safe, and well-tolerated. This treatment may be beneficial in patients with ocular surface diseases due to SS or GVHD that are refractory to standard therapies. Further prospective studies with longer follow-up times and larger sample sizes are warranted to confirm these benefits. In addition, other amniotic membrane devices are available that warrant further investigation to evaulate their efficacies in these diseases.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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