Prokera and nerve generation

[ebi1368]

I just found this about Prokera. Has anybody heard of Tufts Medical Center in Boston? Is it a well-know institution?

"In the clinical trial, patients who completed the one-month and three-month study with cryopreserved amniotic membrane (PROKERA) showed significant improvement in their DEWS score, pain score, TFBUT, fluorescein staining, and SPEED score. Further, these patients exhibited a significant increase in central corneal nerve density both at the one-month and three-month periods, and significant improved corneal sensation from a baseline of 3.25 ± 0.6 cm to 5.2 ± 0.5 cm at one-month and 5.6 ± 0.4 cm at three-months. There was also improved corneal surface topography in terms of wavefront aberrations as well as the cylinder that is induced in dry eye patients. These results were confirmed by a masked reader at Tufts Medical Center in Boston."


https://www.marketwatch.com/press-re...era-2017-11-09

[Guest]

I’d like to see the actual study...because the last study I saw, they asked patients to take cyclosporibe, serum tears, antibiotics and other drugs along with the prokera. So how do you know what’s causing healing?

[ebi1368]

I’d like to see the actual study...because the last study I saw, they asked patients to take cyclosporibe, serum tears, antibiotics and other drugs along with the prokera. So how do you know what’s causing healing?

In the control group, there was not much change in the symptoms. Control group are the one with maximum treatment but no Prokera.

"In this prospective randomized clinical trial, subjects with DED were randomized to receive CAM (study group) or conventional maximum treatment (control). Changes in signs and symptoms, corneal sensitivity, topography, and in vivo confocal microscopy (IVCM) were evaluated at baseline, 1 month, and 3 months."

[ebi1368]

I’d like to see the actual study...because the last study I saw, they asked patients to take cyclosporibe, serum tears, antibiotics and other drugs along with the prokera. So how do you know what’s causing healing?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5574308/

[ebi1368]

"For the study group, PKS was inserted in the office under topical anesthesia with 0.5% proparacaine hydrochloride eye drops. After placement, the subjects were asked to continue topical medications as needed and return 3–5 days later to remove the PKS. Subjects in the control group were asked to continue their conventional maximum treatment throughout the duration of the study including artificial tears, cyclosporine A, serum tears, antibiotics, steroids, and nonsteroidal anti-inflammatory medications. All subjects returned at 1 and 3 months for clinical evaluation."

The one with Prokera just did topical medication as needed. I am not sure what that means but I think it is not the Serum and etc.

[Guest]

I know several people with neuropathic pain who have done this and general results seem to be it helped a bit, but nothing like the drastic pain and symptom reduction this study shows.

[ebi1368]

I know several people with neuropathic pain who have done this and general results seem to be it helped a bit, but nothing like the drastic pain and symptom reduction this study shows.

Thanks for your note. What is Neuropathic pain? Is it when you have good TBUT and schmire test results but still have pain.

I know I am both AD and MGD. I do not have problem in high humidity condition. My pain starts when I am in low humidity.

[Guest]

Please expand and read the full study...copy and paste from the methods section...
2.2. Treatment Procedure


For the study group, PKS was inserted in the office under topical anesthesia with 0.5% proparacaine hydrochloride eye drops. After placement, the subjects were asked to continue topical medications as needed and return 3–5 days later to remove the PKS. Subjects in the control group were asked to continue their conventional maximum treatment throughout the duration of the study including artificial tears, cyclosporine A, serum tears, antibiotics, steroids, and nonsteroidal anti-inflammatory medications. All subjects returned at 1 and 3 months for clinical evaluation

The patients took prokera AND serum, cyclosporine, antibiotics, steroids and NSAIDs...so again I ask you, how do you know if prokera healed the nerves or if it was the other drugs?

You need a study where the participants only use artificial tears and prokera. That way you know the nerve regeneration was directly attributed to prokera. In my opinion this study proves that aggressive drug therapy heals nerves, not prokera.

ANNNDDD...the people doing this study have a financial stake in the cryopresevation and proprietary use of he membrane. They were smart to run the study this way, it almost guaranteed good results. They will claim that the control took all the sane drugs except prokera. But again, you still can’t delineate between what’s working. That’s why you need a control that gets a ring with no membrane and the study group gets prokera, no other drugs. Once that study comes out, we can have a conversation about prokera. Otherwise, I believe serum applied hourly is probably as effective. (That’s 100% speculation btw).

[ebi1368]

Please expand and read the full study...copy and paste from the methods section...
2.2. Treatment Procedure


For the study group, PKS was inserted in the office under topical anesthesia with 0.5% proparacaine hydrochloride eye drops. After placement, the subjects were asked to continue topical medications as needed and return 3–5 days later to remove the PKS. Subjects in the control group were asked to continue their conventional maximum treatment throughout the duration of the study including artificial tears, cyclosporine A, serum tears, antibiotics, steroids, and nonsteroidal anti-inflammatory medications. All subjects returned at 1 and 3 months for clinical evaluation

I could be wrong but from what I understand, they have two different group.

Study group and control group. Study group are the ones that did Prokera + topical medications. I do not know anything about topical medication.

"For the study group, PKS was inserted in the office under topical anesthesia with 0.5% proparacaine hydrochloride eye drops. After placement, the subjects were asked to continue topical medications as needed and return 3–5 days later to remove the PKS."

Control group is one with serum drop and etc.

"Subjects in the control group were asked to continue their conventional maximum treatment throughout the duration of the study including artificial tears, cyclosporine A, serum tears, antibiotics, steroids, and nonsteroidal anti-inflammatory medications. All subjects returned at 1 and 3 months for clinical evaluation"

In the plots, patient with maximum treatment did not see and relief.

[ebi1368]

I emailed one of the writer and here is the response. I asked if Proker help my visual symptoms and dry eye


"Ghosting and haloes after Lasik are not uncommon & mostly impact night vision when the pupil dilates. Common causes include: High order aberrations (HOA), residual refractive error, or dry eye. Since your doctor already excluded HOA and residual error, treatment of dry eye with Prokera would be very helpful. Our previous studies have shown lasting effect (3 months+) after single Prokera treatment. "

[Guest]

I could be wrong but from what I understand, they have two different group.

Study group and control group. Study group are the ones that did Prokera + topical medications. I do not know anything about topical medication.

"For the study group, PKS was inserted in the office under topical anesthesia with 0.5% proparacaine hydrochloride eye drops. After placement, the subjects were asked to continue topical medications as needed and return 3–5 days later to remove the PKS."

Control group is one with serum drop and etc.

"Subjects in the control group were asked to continue their conventional maximum treatment throughout the duration of the study including artificial tears, cyclosporine A, serum tears, antibiotics, steroids, and nonsteroidal anti-inflammatory medications. All subjects returned at 1 and 3 months for clinical evaluation"

In the plots, patient with maximum treatment did not see and relief.

The other topical drugs are written I explained everything in my text. The control group still took topical drugs but what I’m trying to say is, if you’re taking serum and steroids and anti-inflammatory drugs, How do you know what impact prokera had?

If you’re telling me that you want to take steroids, serum and prokera and NSAIDs... then I say do it because that’s what the study proved.

[Guest]

I don’t mean to be a Debbie downer, but I think you’re looking at prokera as a panacea...and it is not. I understand you’re in pain...if say find a doctor that will prescribe that exact, extremely aggressive protocol. But I’m stating right here and now, if you do prokera alone, I doubt you’ll have much benefit. That’s just my personal opinion based on my understanding of how it works.

Ay the end of the day, I’d say you really believe this will help. It probably won’t hurt, so try it and report back here for us. I hope you get relief from it honestly.

[deep_dry_eye]

For what's worth, I believe in Prokera, my doctor also as well. My dr claims >90% of his patients show some improvement in both symptomatic as well as clinical.

I personally had persistent foreign body sensation, the severity and frequency of it has dramatically declined 3months post-op prokera. Of course, I am also on monthly IPL, restasis, xiidra, omega 3 supplements, GLA supplements. However, the improvement happened post-prokera, so I attribute a lot of my improvement to it.

For what's it worth, Prokera is very very safe, it just costs money. If you've exhausted other treatment options including, IPL, xiidra, restasis (of which all 3 treatments i firmly believe in), I would say go give Prokera a try. It really really improved my quality of life.

[ebi1368]

I am planning to do Prokera but I will stick to serum drop and etc.
I hope it helps

[Guest]

I am planning to do Prokera but I will stick to serum drop and etc.
I hope it helps

I’m super curious, good luck!