PROKERA^® is a class II medical device comprised of cryopreserved amniotic membrane (AmnioGraft^®) clipped into a thermoplastic ring set. PROKERA^® combines the functionality of a symblepharon ring with the biologic actions of cryopreserved amniotic membrane (AmnioGraft^®) to create a unique treatment option for a wide range of ocular conditions including moderate to severe dry eye disease, recurrent corneal erosions, herpetic keratitis, neurotrophic corneal ulcers, among others. The PROKERA^® device configuration enables easy insertion in the office, hospital bedside or following surgical procedures to prevent adhesions while delivering the wound repair and wound healing actions of amniotic membrane.

PROKERA^® is used to manage ocular surface healing for a variety of indications including:

• Corneal epithelial defects
• High-risk corneal transplants
• Chemical burns
• Stevens-Johnson Syndrome

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.

Are there any special instructions to follow while PROKERA^® is inserted?

• 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®

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.

About PROKERA^®

The cryopreserved amniotic membrane in PROKERA^® is the only amniotic membrane tissue that helps eye surface wound repair and wound healing. PROKERA® allows easy insertion and removal of amniotic membrane in your doctor's office. When PROKERA^® is placed on your eye, it will aid in healing, reduce pain, minimize scarring, and decrease inflammation.

 

PROKERA^® is a registered trademark of Bio-Tissue, Inc.