Handling Cryopreserved Amniotic Membrane Devices

An innovative cryopreserved amniotic membrane device (ProKera®, Bio-Tissue, Inc. Miami, FL www.biotissue.com) is available for treating corneal epithelial defects without the need for surgery.

 

 

The cryopreserved amniotic membrane is fastened in a dual ring set so that the sticky stromal side is facing the corneal surface when inserted in the eye. ProKera® is retrieved from its refrigerated shipping container and handled in the same manner as cryopreserved amniotic membrane.

 

 

ProKera® Insertion

Before Insertion:

  1. Always handle ProKera® using sterile/aseptic technique
  2. Make available the following: lid speculum, gloves, anesthetic drops and antibiotic drops
  3. Thaw at room temperature for 5-10 minutes (do not use a microwave or water bath)
  4. Open the outer foil peel pouch and aseptically present the inner clear pouch to the sterile field
  5. Use sterile forceps provided to grab the clear inner pouch
  6. Use sterile scissors to cut the inner package with enough space to remove the device
  7. Use blunt forceps or fingers to grab only the outer ring (NOTE: handle with care as the device is slippery)
  8. Avoid touching the tissue in the center of the ProKera® device to prevent tearing

Insertion:

  1. Place the anesthetic drops in the eye
  2. Insert a lid speculum
  3. Do not trim excess membrane around the device
  4. Insert ProKera® beneath the speculum by lifting the lid speculum
  5. Place antibiotic drops in the eye
  6. ProKera® can remain in the eye for up to 30 days, until the ocular surface has healed or until the membrane in the device has dissolved

 

Removal:

  1. There is no need to remove ProKera® during fluorescein staining and Tonopen measurement of the eye pressure (1,2)
  2. If temporary removal is desired, place ProKera® in a sterile preservative-free pH-balanced saline solution before re-insertion
  3. Upon completion of treatment, remove ProKera® by grabbing the conformer rim with forceps, with or without a lid speculum or lubricating eye ointment

 

1. Kobayashi A, Ijiri S, Sugiyama K, Di Pascuale MA, Tseng SCG. Detection of corneal epithelial defect through amniotic membrane patch by fluorescein. Cornea 24:359-360, 2005.

2.Yoshita T, Kobayashi A, Takahashi M, Sugiyama K, Tseng SCG. Intraocular pressure by noncontact tonometry over amniotic membrane patch in human.Am J Ophthalmol 141:508-511, 2006.)

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If you have additional surgical questions after viewing this information, contact OSREF’s Research Director, Scheffer C.G. Tseng, MD, PhD, by e-mail at stseng@ocularsurface.comor by phone at 305-274-1299.

Financial Interest Disclosure: Dr. Tseng and his family are more than 5% shareholders in TissueTech, Inc. and Bio-Tissue, Inc. which currently distributes AMNIOGRAFT® and PROKERA®

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