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Post Info TOPIC: Question about USA FDA approval


Senior Member

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Date: Tue Nov 22 9:12 AM, 2005
Question about USA FDA approval
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Hi,


In some correspondence that I got from a US doctor regarding Intacs it mentioned that Ferra rings did not pass FDA approval. Yet they are approved in some european countries. Can anyone shed some light on this, was it the case that they were a different size ring implant like apparently is the case with intacs in US as opposed the Europe?



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Anonymous

Date: Tue Nov 22 12:56 PM, 2005
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Chris... another good point... F/Rings was thought to stretch the cornea too much by the FDA (although widely used in many other countrys), however on the other hand and something which is not talked about is that Intacs corrects less than F/Rings (please read the topic on this in this section called "Centre for Sight") also Intacs was developed for myopia not kc... but it is used for kc as an "HDE" treatment in the U.S (Intacs prescription inserts were approved under a Humanitarian Device Exemption (HDE) by the FDA in July 2004, allowing Intacs to be used for treating keratoconus)


Considering that the Rings option is best used to avoid a transplant... so it would seem that a ring that corrects more is what is needed to do that... and why there are poor results in intacs for these people with advanced kc. 


I think F/Rings is more suited for kc, as it was developed for it (again read the topic mentioned)... and with the Intacs people getting a foot hold in the U.S its harder to enter the U.S market for F/Rings. Anyway its being used (F/Rings) all over the world, the ferrara Rings site will send you a list i think, of places near to you (or should i say the countries near to you) Take Care



-- Edited by QuintriX at 03:26, 2006-01-09

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Member

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Date: Tue Nov 29 3:15 AM, 2005
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Chris- I recently had intacs implanted. A representative from the company that produces the intacs was present for the procedure. I had the opportunity to discuss his take on Ferrara vs. Intacs and the lack of FDA approval for ferrara. He did note the increased correction achieved with ferrara, but suggested that they would never be given the green light in the U.S. because they are placed so close to the optic zone. While this allows for more corrrection, it presents its own set of problems. I can speak from personal experience that at night, I can sometimes see the the outline of the intacs. Not a huge issue, but something I am glad happens only at night. The thickest segments of Intacs currently manufactured are not FDA approved. My doc and the rep for the company both noted that the thicker segments offer the possibilty of even more correction.  



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Anonymous

Date: Tue Nov 29 12:26 PM, 2005
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A warm welcome to you Paixbouche,


Thanks for posting about your experiance, I read from an attachment sent for a friend of mine from Dr Boxers office, that said Ferrara Rings was found to stretch and so thinned an already thin cornea and so did not get FDA approval in the U.S. If this is right or wrong i have no idea.


I can imagine that the placing of the f/ring nearer to the center may cause more problems in the night time, but a f/rings doctor may dispute that as it depends on your pupil size.


Personally i think there is a learning curve still going on as I don't think the results have been compared for the night time (the night time being the real test for light shatter!)


Interestingly a friend of mine got sent a booklet from the "Centre of sight" and she said that there was not one mention of Ferrara Rings in the booklet, it only had about Intacs. (well i found out later it was due to with Intacs the pupil size of the patient did not come in to play as much as F/Rings)


It says that light is reflected away out of the eye with f/rings in the link for the "centre of sight".


I have been reading that the use of one Intac segament was seen to work better than two. They increase the thinkness of that one segament to correct more and found they got better results (theres a topic on this in the surgical methogs section)


These things are what i've come across... thanks again for your experiance.


Glad that you doing well and please keep in contact!


All the best



-- Edited by QuintriX at 06:17, 2006-01-09

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Member

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Date: Thu Dec 1 12:02 AM, 2005
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As far as my experience went with pursuing intacs, I couldn't agree more with things still being up in the air. Every opthamologist I have spoken with seems to have a different opinion on Intacs for Kc, when they are appropriate, their effectiveness, safety, risks, placement methods, etc. Some have never heard of them, others have suggested that if I am considering Intacs than I might as well get a transplant, others insistent that I just hadn't found the "right" rigid contact.



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Anonymous

Date: Thu Dec 1 1:34 AM, 2005
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Hi Paixbouche,


Your post is so true, its very "ad-hoc" the way kc is dealt with. The unwary punter can be so easily be lead to believe something completely different, to the opinion of another doctor who has the experiance to know, about how to proceed with the issues the patient did not know of, and so making them unable to take an informed choice.


I think with the I/F Rings option if the surgeon is experianced then that makes the difference. Its a new treatment for some, and a "routine" treatment for others, who's thinking and knowledge is far a head of everyone elses.


I have this good feeling that your very happy with you vision now, its a valuable option I feel, when there are limited options for us, considering there are those who think transplants are ok (that gets me angery!)


Please feel free to write when you want to, about your story leading up to your treatment and after. It would be very educational for us, thanks for posting.


All the best



-- Edited by QuintriX at 01:39, 2005-12-01

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Member

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Date: Thu Jul 20 3:49 PM, 2006
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I think that FERRARA RINGS are not FDA approved because they put some incisions in the cornea to flatten it. The incisions are so close to the ring that they can anytime get extruded. In a study which said about 3% of the cases have rings extrusion but all were dealt with care and re-implantation was possible in all the cases. 

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Executive

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Posts: 397
Date: Fri Jul 21 1:40 AM, 2006
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Hi Rajat Abbey,
I did not know that corneal incisions where part of the Ferrara ring technique... actually I know very little about the entire procedure. But this is of interest to me as I have had mini ark to correct my KC. Mini Ark involves incisions so of course I am interested in any other technique that includes the same surgery. Do you have any links to data explaining these 'flattening incisions'?

Regards,
Hari

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