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  • Prokera update

    Thanks Hank for your postings on this subject.

    I contacted Dr. Panzer from Houston Texas and indicated that there’s been some confusion amongst patients, on whether ProKera is a suitable treatment for severe dry eye with some corneal staining. His reply, posted with his permission:

    Ok..so here is my take on the matter. If you are miserable, and have a staining non healing cornea..its wonderful.
    What I do not want folks to think is that it is in and of itself a "treatment" for dry eye.
    I feel the hormones are a "treatment" for dry eye. My source is Dr. Sullivan's son. He persuaded me to put in the TearLab. I told him that the only way I would do that would be if he would tell me how to help people with dry eye.
    Otherwise what on earth is the point of a test.
    I have several hundred patients on the drops. Only a few are not better. Some actually are better immediately.
    Many require bandage contact lenses worn at night to feel better. There is not one size fits all. This is a complicated area. I have been blessed with success. The folks who are not successful will surely be there and I will be depressed.
    As I said, if you are light sensitive and miserable, ProKera is the place to be. If its just dry...I think the drops and perhaps a standard bandage might be helpful.


    The upshot is, to date, Prokera is being used on some DES patients who have exhausted all other treatment options.
    It's also more widely distributed than originally thought. For example, it’s distributed by Labticians in Canada. If you phone them, they may be able to let you know who’s ordering the product in your city.

    It's definitely worth discussing with your ophthalmologist, if you are a severe dry eye patient. Below is the product insert:

    Product Insert
    Description: ProKeraŽ is a Class II medical device comprised of a cryopreserved amniotic membrane graft fastened to a
    thermoplastic ring‐set. The amniotic membrane is derived from Donated Human Tissue. The cell activity in the tissue has
    been inactivated to eliminate the possibility of graft rejection while retaining the natural biologic properties. ProKeraŽ is
    stored in a validated medium made of Dulbecco’s Modified Eagle Medium/Glycerol (1:1) containing Ciprofloxacin and
    Amphotericin B.
    Indications:
     ProKeraŽ is intended for use in eyes in which ocular surface cells have been damaged or underlying stroma is inflamed or
    scarred. Acting as a self retaining biological bandage, ProKeraŽ effectively treats superficial corneal surface diseases by
    reducing pain, suppressing inflammation, promoting epithelial healing, and avoiding haze.
     ProKeraŽ is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or
    adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without
    the need for sutures.
     ProKeraŽ is for single and prescription use only by a licensed physician.
    Contraindications:
     ProKeraŽ should not be used in eyes with glaucoma drainage devices or filtering bleb.
    Precautions:
     Do not use ProKeraŽ if the packaging is damaged – Contact Bio‐Tissue immediately if there is any abnormality observed
    in any area (e.g. labeling, packaging, shipping, missing information, etc).
     Once the outer foil pouch is opened, ProKeraŽ should be used as soon as possible.
     Do not sterilize or re‐sterilize the product. Do not autoclave before use.
    Warnings:
     If the patient cannot close the eyelid, has an incomplete blink or demonstrates any other signs of exposure, address
    these clinical issues before or at the same time of placing ProKeraŽ.
     Do not use on patients with a history of drug reactions to Ciprofloxacin or Amphotericin B.
     As with the use of any human tissue, the possibility of infectious agent transmission cannot be completely eliminated
    although all screening and microbial testing results were satisfactory for this donor.
     It is imperative that the device is stored properly until use.
     In the rare instance that the patient cannot tolerate wearing ProKeraŽ, the device should be removed.
    Instructions:
     Allow ProKeraŽ to thaw at room temperature in its original unopened packaging for at least 5‐10 minutes.
     Open the outer foil peel pouch and aseptically present the inner clear pouch to the sterile field.
     Open the inner clear peel pouch and remove the ProKeraŽ device using blunt forceps.
     Rinse ProKeraŽ with sterile saline solution to reduce stinging sensation.
     Place ProKeraŽ on to the cornea.
     After placement, complete the Donor and Recipient Information Form and return to Bio‐Tissue immediately. If the tissue
    is discarded, please record this on the Donor and Recipient Information Form.
     Upon dissolution of membrane or completion of treatment, remove ProKeraŽ.
     Do not leave in the eye longer than 30 days.
    Recipient Records: It is the responsibility of the transplanting entity to maintain records for the purpose of tracing tissue
    post‐transplantation.
    Adverse Reactions: Any adverse event potentially attributable to the use of ProKeraŽ must be reported promptly by the
    physician to Bio‐Tissue by completing the Adverse Event Form provided with the product.
    Also see Handling & Storage Instructions and Certificate of Analysis provided with each shipment.
    Recommended Storage Before Use: After receipt, store ProKeraŽ as follows until time of use:
    Location & Temperature Use After Receipt
    Unopened Insulated Shipping Container Within the expiration date printed on outer shipping box
    Standard Refrigerator
    1°C  10°C (33.8°F  50°F)
    Within 3 months of placing in the refrigerator or until
    expiration date printed on outer product packaging,
    whichever comes first
    Standard Freezer (home or general use)
    ‐49°C  0°C (‐56.2°F  32°F)
    Within 1 year of placing in the freezer or until expiration
    date printed on outer product packaging, whichever
    comes first
    ‐80°C Freezer
    ‐85°C  ‐50°C (‐121°F  ‐58°F)
    Until the expiration date printed on outer product
    packaging (shelf‐life is 2 years from date of manufacture)
    Effective Date 11/09/11 Version 7
    Last edited by Pinky; 28-Sep-2012, 14:42.

  • #2
    what "hormones " is he referring to? dhea? i tried testosterone cream years ago and unfortunatley it did nothing...except give me clogged glands near my lashes that has to be removed by neeedle

    i know wiht some people tho hormones help..
    Jenny

    Comment


    • #3
      I believe he's talking about testosterone/progesterone drops.

      Comment


      • #4
        Pinky, thanks so much for this info- I'd love to give these drops a try. Dr. Panzer is 1500 miles from where I live, so I'll really have to think about this but he's dead on- a nearby eye practice offers the tearlab testing- I called and said," before I come in, once my tear film is analyzed- what can you offer in the way of help?" It's the same old thing, steroids, plugs and restasis!

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        • #5
          Does anyone know how long one would have to wear this in order to see any benefits? I watched a youtube video on Prokera and it doesn't seem like you can function normally while wearing the device. And wearing PROSE with this thing is definitely out of the question.
          FOR WE WALK BY FAITH, NOT BY SIGHT (2 Corinthians 5:7).

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          • #6
            I believe you have to wear it for about three weeks, and yes, your vision is blurred while wearing it. Some patients require a temporary tarsorrhaphy.

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            • #7
              ///////////
              Last edited by hankm9; 23-May-2016, 21:43.

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              • #8
                ProKera can be done by an OD.

                http://www.healio.com/optometry/corn...atment-options

                The ProKera (BioTissue) device is designed for patients with severe ocular surface disease.
                Dr. Marcolini explained how the device is made.
                "After a woman gives birth, they harvest pieces of the amniotic sac and cryogenically freeze the tissue," he said. "ProKera is like a PMMA lens or scleral shell. It's like having this amniotic membrane that can be put on the surface of the eye like a bandage lens.
                "What's important is that optometrists can do this," Dr. Marcolini said. "There's no suturing. One of the ODs in our office did this recently. The patient had bad superficial punctate keratitis, surface disease and Sj?gren's syndrome and was developing a dellen."
                The ProKera is absorbed into the patient's eye over a period of 7 to 14 days.
                "It has all of the great things that make your cornea healthy, such as lactoferrin and metalloproteinases, straight out of the womb," Dr. Marcolini said. "It's like a bandage lens on steroids."
                To perform the procedure, the doctor must use Betadine (5% sterile ophthalmic preparation solution, Alcon) to sterilize the eye, hold down the lower lid and place the ProKera on the eye with forceps. He recommended soaking the membrane in saline to reduce stinging upon application.
                Dr. Marcolini is affiliated with the New Jersey Omni Eye Institute and is president of the New Jersey Society of Optometric Physicians.
                • Disclosure: Dr. Marcolini has no relevant financial interests.

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                • #9
                  Webinar on ProKera Oct. 28th:

                  http://www.biotissue.com/news-events/Webinars.aspx

                  AmnioGraftŽ & ProKeraŽ for Corneal Indications
                  Learn how to solve difficult corneal indications through employing the novel therapeutic actions of Amniotic Membrane.
                  Thursday, October 28, 2010 (7:00 pm PST / 10:00 pm EST)
                  &
                  Wednesday, November 3, 2010 (8:00 pm EST)
                  Speaker
                  Scheffer C.G. Tseng, M.D., Ph.D.

                  Just realized the Webinar was in 2010, missed it by two years... sigh.
                  Last edited by Pinky; 01-Oct-2012, 21:36.

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                  • #10
                    ////////////////////
                    Last edited by hankm9; 30-Oct-2016, 02:05.

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                    • #11
                      Okay let me make sure I understand this. Sorry for asking fairly trivial questions, I'm just super busy right now and don't have time to go through all these posts thoroughly.

                      Is AM used to cover the entire eye surface?
                      Is PROKERA used just on the iris and a part of the sclera, and covers a similar amount of surface area as a scleral lens?

                      Do both of these require surgery, or is it only AM that requires surgery?
                      Is AM and/or PROKERA available in Canada?

                      What kind of downtime from work would be necessary if one was to try AM or PROKERA?

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                      • #12
                        Tankie, the Bio-Tissue site says Prokera is FDA approved and also there's a press release indicating approval for Italy. I couldn't find anything about Canada. It could be there, but I didn't see it.The website has an image which looks like a contact lens in a plastic frame so it is inserted in office procedure, not stitched in place surgically. Still actively looking into it. I haven't any info on the AM. Hope this helps in part:

                        From the Prokera website:
                        http://www.biotissue.com/products/prokera.aspx


                        "PROKERAŽ is class II medical device comprised of cryopreserved amniotic membrane clipped into a thermoplastic ring set. PROKERAŽ combines the functionality of a symblepharon ring with the biologic actions of cryopreserved amniotic membrane to create a unique treatment option for corneal and limbal wound healing. The PROKERAŽ device configuration enables easy, sutureless 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.
                        PROKERAŽ is used to manage ocular surface healing for a variety of indications including:

                        Corneal epithelial defects
                        High-risk corneal transplants
                        Recurrent Corneal Erosion
                        Infectious Diseases (Herpes/Keratitis)
                        Stevens-Johnson Syndrome & Chemical Burns

                        Note: PROKERAŽ should be used cautiously with patients with irregular elevations of the ocular surface (e.g. glaucoma drainage devices)
                        "PROKERAŽ is always manufactured so the stromal side of the tissue will be in contact with the corneal and limbal surface. It is not necessary to trim excess membrane from around the edges of the device.

                        "PROKERAŽ can remain in the eye up to 30 days. However, PROKERAŽ should facilitate healing in most defects within 5-10 days at which point the membrane in the device will naturally dissolve and the ring set can be removed

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                        • #13
                          Thanks for the reply. Now the question is, would a doctor be willing to try something like this out simply because the patient complains that he/she has a lot of pain on the surface of the eye, and would like to try use this "band aid" to heal it, even though the underlying problem in theory is MGD.

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                          • #14
                            ////////////
                            Last edited by hankm9; 23-May-2016, 21:41.

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                            • #15
                              "Force them too. It's not going to kill you or make anything worse. It'll either help or dissolve without doing anything. So it's worth a shot. What's it to doctors to refuse something you're willing to pay for that requires 10mins to insert?

                              We need more dry eye patients to try this. Especially with the symptoms: photophobia, ocular pain & mild inflammation."

                              I agree.

                              @Tankie. They have ordered ProKera at the Eye Care Centre in Vancouver. It's just a matter of getting some of the doctors there to try it on DES patients.

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