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Prokera Consent Form

Prokera Consent What is PROKERA®? PROKERA® is a medical device used by eye doctors around the world to protect, repair and heal damaged eye surfaces. PROKERA® is made by clipping a piece of amniotic membrane tissue in between two rings made out of a clear, flexible material. What is amniotic membrane tissue? Amniotic membrane is part of the placenta. It is the tissue closest to the baby throughout development in the womb. Amniotic membrane protects the baby from any harm and it has natural therapeutic actions which help the baby develop. Is PROKERA® comfortable? The rings that hold the amniotic membrane in place are slightly thicker than an average contact lens, so they may cause some discomfort in sensitive eyes. To aid healing and reduce your eye’s exposure to outside dryness, your ophthalmologist may partially close your eyelid after PROKERA® is inserted. What does PROKERA® do? Helps the eye heal: The amniotic membrane tissue in PROKERA® has natural therapeutic actions that help damaged eye surfaces heal faster. Eyes treated with PROKERA® have quicker healing, less pain, less scarring, and less inflammation. Protects the eye surface: The amniotic membrane in PROKERA® is thin and clear like the tissue on the surface of your eye and protects your eye’s damaged tissue while inserted. What does PROKERA® treat? PROKERA® is used by physicians all over the world to treat eye diseases such as corneal scars, chemical burns, corneal defects, partial limbal stem cell deficiency and many other ocular surface conditions. Where does the amniotic membrane come from? The placentas used to prepare PROKERA® are donated by consenting mothers after cesarean section (C-Section) births. Mothers that donate are fully informed, have healthy lifestyles, and are tested against infectious diseases prior to donation. Is PROKERA® safe? PROKERA® is a safe, effective treatment provided by a tissue bank regulated by the FDA. The issue has passed many quality control tests before it is provided to your doctor. Ask your doctor if you are concerned about the risks involved with using a human tissue device.
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  • Avoid rubbing your eyes, strong blinking, or moving PROKERA® with your fingers
  • Do not remove PROKERA® without consulting your physician first · Do not swim or soak your face with water
  • Shower only when the eye is tightly closed
  • Do not drive or operate heavy machinery or perform functions that require unobstructed vision or good depth perception
  • Use eye drops and other medications as prescribed by your physician
  • Contact your physician right away if you are uncomfortable or have any other problems with PROKERA®
  • If Prokera lens happens to fall out, please discard right away.
  • You can expect to feel a foreign body sensation in eye, this will decrease as amniotic membrane dissolves.
  • Vision will be blurry until surface of eye completely heals