Sandra Lora Cremers, MD, FACS

Here is a quick video showing the sight saving effect of Amniotic Membrane. I will post a video soon on how to insert a Prokera as it is very easy and minimally uncomfortable. 

Here is a great review article by Kunal Suri, M.D.; Mustafa Kosker, M.D.; Irving M. Raber, M.D.; Kristin M. Hammersmith, M.D.; Parveen K. Nagra, M.D.; Brandon D. Ayres, M.D.; Colleen P. Halfpenny, M.D.; Christopher J. Rapuano, M.D

http://www.medscape.com/viewarticle/811163

Amniotic membrane has been used widely in the treatment of ocular surface disease since early 1990s.^[1] The usefulness of amniotic membrane has been attributed to its anti-inflammatory, anti-fibrotic, anti-vascularization, and anti-scarring effects and also to its ability to enhance epithelial healing. Indications for its use include a broad spectrum of ocular surface disorders, such as limbal stem cell deficiency (LSCD),^[2,3] corneal ulcers of different etiologies,^[4–6] chemical and thermal burns of the cornea,^[7,8]persistent epithelial defects (PEDs),^[9] pterygium surgery^[10] or conjunctival replacement after removal of conjunctival lesions,^[11] and symblepharon removal and fornix reconstruction.^[12] It is often secured with sutures or with fibrin tissue adhesive.^[13,14] The disadvantages of sutures include prolongation of surgical time,^[13] postoperative discomfort,^[13] and the risk of inflammation^[15] or infection^[16] associated with them.

ProKera (Bio-Tissue, Inc., Doral, FL) is a cryopreserved amniotic membrane, clipped to a dual polycarbonate ring system that was approved by U.S. Food and Drug Administration in 2003. It acts as a biological bandage with the stromal side in contact with the cornea. The polycarbonate ring is similar to a symblepharon ring with an inner diameter of 16 mm and an outer diameter of 21 mm. ProKera is placed in the eye in a similar fashion to a large contact lens. Compared with surgical application of amniotic membrane, the ProKera device obviates the need of an operating room and is therefore an easier, less time-consuming and less costly process that can be performed readily in the office.

There are a few case reports and case series in the literature regarding the use of ProKera in bacterial keratitis,^[17] chemical injury of the cornea and conjunctiva,^[18] fornix reconstruction,^[19] toxic epidermal necrolysis (TEN),^[20] and Stevens-Johnson syndrome^[21] (Table 1). The largest reported series consists of 21 eyes of 20 patients, in whom ProKera was inserted for a variety of ocular surface and orbital disorders.^[22] We report our larger experience with this sutureless amniotic membrane device to treat various ocular surface disorders

PROKERA® is a therapeutic 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.

Amniotic membrane is part of the placenta and is the tissue closest to the baby throughout development in the womb. Amniotic membrane protects the baby from any harm and has natural therapeutic actions which help the baby develop. The tissue has healing properties that aid in ocular surface repair.

The amniotic membrane tissue in PROKERA® has natural therapeutic actions that help damaged eye surfaces heal. Eyes treated with PROKERA® have quicker healing, less pain, less scarring, and less inflammation. 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. 

PROKERA® is used by eye doctors to treat eye diseases such as keratitis, corneal scars, chemical burns, corneal defects, partial limbal stem cell deficiency and many other ocular surface diseases with inflammation. 

PROKERA® is a safe, effective treatment provided by a tissue bank regulated by the FDA. The tissue 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.

The products offered by  Bio-Tissue® (PROKERA®, AmnioGraft®, & AmnioGuard®) are cryopreserved human Amniotic Membrane. They are designated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), minimally manipulated and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1270, 1271).

Live, healthy mothers may be considered eligible for placental donor status following elective Cesarean Section delivery. These mothers provide full informed consent and are put through extensive social habit screening, medical history and records review for infectious, malignant, neurological, auto-immune, transmissible diseases, and independent, serological CLIA lab testing (using FDA licensed test kits) which are non-reactive (negative) for the following tests: