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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
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
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