Focus of the Report: This report evaluates the use of the ProKera device (Bio-Tissue Inc.) for the treatment of ocular indications.
Technology Description: ProKera is comprised of a cryopreserved human amniotic membrane graft that is fastened to an ophthalmic conformer without the use of sutures. Amniotic membrane promotes healing of epithelial surfaces. The device can be inserted into the patient’s eye(s) during a short physician office appointment or other outpatient setting.
Controversy: Conventional treatments for dry eye disease, corneal ulcers, and ocular burns/corrosion may be inadequate, requiring more aggressive intervention (e.g., surgical treatment) to promote healing and prevent persistent epithelial defects, progressive corneal ulceration, and perforation. ProKera implantation is a minimally invasive treatment with the potential to be equally or more effective than other treatment options.
Key Questions:
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Does ProKera as a stand-alone treatment improve outcomes in patients with ocular disorders due to disease or injury relative to comparator interventions?
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Does ProKera used as an adjunct to conventional treatment result in better outcomes than conventional treatment alone?
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Is ProKera safe?
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Have specific patient selection criteria for the use of ProKera for treatment of ocular disorders been established?
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