PROKERA® is an ophthalmic conformer containing cryopreserved amniotic membrane (AMNIOGRAFT®) to assist in ocular surface wound repair and wound healing. PROKERA® consists of a polycarbonate ring-set with a piece of cryopreserved amniotic membrane clipped in between. The conformer is inserted between the eyeball and the eyelid. This ring-set sits on the ocular surface like a symblepharon ring and the stromal side of the cryopreserved amniotic membrane is in contact with the corneal surface and limbal area.

The cryopreserved amniotic membrane provides  anti-inflammatory, anti-scarring, anti-angiogenic properties, and supports epithelial adhesion and differentiation. The polycarbonate ring-set also assists in ocular surface healing by maintaining space in the orbital cavity and preventing conjunctival closure or adhesions during the healing process.

PROKERA® acts as a sutureless therapeutic graft as it delivers the permanent healing benefits mentioned above while providing a temporary physical environment to facilitate this healing process for the corneal and limbal surfaces. When used in an office setting, PROKERA® provides crucial sight-saving acute treatment that can possibly prevent or delay a surgical procedure or save a graft failure due to high risk corneal transplant.

PROKERA® is available in 2 sizes:

Most adult patients will feel comfortable with a 16 mm PROKERA® device. The 15 and 16 mm refer to the inner diameters of the ring-set holding the  cryopreserved amniotic membrane. A patient's interpalpebral width can be measured to select the correct size. PROKERA® should not be used for patients with unusually tight eyelids.

PROKERA® acts as a sutureless therapeutic graft and the epithelial healing takes place with the help of cryopreserved amniotic membrane's natural therapeutic actions. Once the corneal surface defect heals as  detected by fluorescein staining, the cryopreserved amniotic membrane clipped into the polycarbonate ring-set will thin out of dissolve completely after releasing the important therapeutic actions. The remaining polycarbonate ring-set should be removed at this time without affecting the host epithelium. Most ocular surface healing is complete in 1-2 weeks. It is recommended that the ring-set remain in the eye no longer than 30 days after insertion. If the membrane dissolves too quickly (less than 1-2 weeks), it may be caused by an exposure problem Therefore, it is advisable to consider a tarsorrhaphy, botox ptosis or a suitable bandage with PROKERA®.

For cases with severe inflammation (e.g. acute chemical burns), it is beneficial to replace PROKERA® every 5 to 10 days to enhance the benefits of the  cryopreserved amniotic membrane which can be reduced due to the polymophonuclear leukocyte (PMN) cells trapped on the membrane.

No. The corneal and limbal surfaces heal underneath the layer of cryopreserved amniotic membrane making it easy to remove the ring-set after healing.

PROKERA® is intended for use in eyes in which the corneal and/or limbal surface has been damaged or inflamed. If the damage is deeper than the epithelium, AMNIOGRAFT ® should be considered as multiple layers can be used to fill the defect and PROKERA® can be placed on top to assist in the epithelial healing.

Due to the device construction and the placement of PROKERA® under the eyelids, PROKERA® conforms to the eye without the need for sutures. PROKERA® will not fall out with normal wear or blink. However, the device may not be secured well in patients with ectropion exophthalmos or severely floppy lids. Additional sutured temporary tarsorrhaphy or Botox ptosis is advised.

No. The cryopreserved amniotic membrane in the PROKERA® ring will thin out as the healing of the corneal surface progresses. This can cause the membrane to detach from the ring. If this occurs, remove the ring. PROKERA® has been assembled with an extra large piece of cryopreserved amniotic membrane to allow for this healing process. Do not trim off any excess tissue. If the ring-set separates, do not try to reassemble it.

The cryopreserved amniotic membrane may show some degradation during wear and thus generate some mucous debris. If this occurs, simply rinse with non-preserved saline.