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Post Info TOPIC: Question about USA FDA approval


Member

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Date: Fri Jul 21 1:40 PM, 2006
RE: Question about USA FDA approval
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This is a link containing some information regarding this:


http://en.wikipedia.org/wiki/Keratoconus


This also contains some information:


http://www.kcsupport.org/Ferrara%20rings.htm


Chech this out:


Intacs vs. Ferrara Rings:


Intrastromal Rings for Keratoconus


Two research groups will report on their experiences with inserting intrastromal ring segments into the cornea to treat visual problems caused by keratoconus.


At the University of California, Los Angeles, Brian S. Boxer Wachler, MD, director of refractive surgery, evaluated results of inserting Intacs into 67 eyes with keratoconus.


At one month, 75 percent of the eyes had gained at least 1 line of UCVA, and 44 percent had at least 3 lines of improvement. Another 63 percent gained at least 1 line of BCVA. However, 18 percent lost 2 lines or more of visual acuity.


Dr. Boxer Wachler said his presentation will include further analysis to try to shed light on why some patients gained and others lost vision from the procedure.


In the second study of intrastromal inserts for keratoconus, a group of Brazilian researchers will report on using a new device, Intrastromal Ferrara Ring Segments (IFRS). All 36 patients in the trial were awaiting penetrating keratoplasty.


Led by Danielle B. Miranda Silva, MD, the group found that BCVA improved in 91.6 percent of the eyes. However, complications ranged from 2.7 percent of the eyes with decentered segments to extrusion of segments in 11.1 percent. No patients lost visual acuity.


 



-- Edited by Rajat Abbey at 13:52, 2006-07-21

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Phase Two

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Date: Sat Jul 22 10:07 AM, 2006
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No where does it say about incisions flattening

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Member

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Date: Sat Jul 22 10:45 AM, 2006
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Read the first link and u'll get it..



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Phase Two

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Date: Sat Jul 22 10:53 AM, 2006
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It saying nothing about the incision flattening the cornea... it says the ring segaments do...


...and your reason of why the FDA did not approve Ferrara Rings in the US... is that something you guessed may be the case or did you read that somewhere too?



-- Edited by QuintriX at 20:14, 2006-07-22

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Member

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Date: Sun Jul 23 9:37 AM, 2006
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I read it somewhere but I do not remember where. But it was clearly written that the reason for FDA not approving it was that they make some incisions in the cornea and the rings are so close to them that there is a risk of extrusion.



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Phase Two

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Date: Sat Aug 5 6:56 PM, 2006
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Well, Ferrara Rings (Kerarings) has been approved in Europe for a long time.


 


  


 

 TIME-TESTED CLINICAL SAFETY

keraring hold's the world's largest and longest clinical performance record among all intracorneal implants available.
It was first implanted in humans in 1991 and to date over 8500 eyes have been successfully implanted, showing Keraring's long-term safety and effectiveness.
Keraring is the only CE-marked instrastromal implant designed for surgical
correction of corneal ectatic disorders.    


 



 REVERSIBILITY

Keraring may be surgically removed allowing the cornea to return to preoperative conditions. The procedure is reversible.

 READJUSTABILITY

keraring segments may be exchanged or repositioned when necessary. Topographic and refractive results are readjustable.


     



 FAST VISUAL REHABILITATION


Minimally invasive procedure allows patients to resume regular activities within 2 days. Corneal and refractional changes happen immediately after Keraring implantation, and result stabilization is achieved after 12 weeks.


 IMPROVED CONTACT LENS TOLERANCE

keraring regularizes corneal surface distortions thus greatly improving contact lens tolerance in Keratoconus patients. 



     



 EXCELLENT PATIENT SATISFACTION

High satisfaction levels reported among Keraring patients confirm that the procedure greatly improves their quality of life.
 


       


 CONVENIENT AND ECONOMICAL PRESENTATION

keraring is supplied with one sterile intrastromal corneal ring segment per box. This unique single-segment presentation provides convenient flexibility and cost savings to deal with each patient's individual needs.



     


 AVOIDS CORNEAL TRANSPLANTATION


Clinical studies confirm Keraring provides corneal morphological correction and stabilization in patients that may otherwise need penetrating Keratoplasty.
Keraring does not compromise corneal transplantation should it be required in the future.



-- Edited by QuintriX at 02:47, 2006-08-06

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Member

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Date: Sat Aug 5 9:33 PM, 2006
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Can you provide me with some results of ferrara rings?? How many countries do have this procedure... IS it in many countries as it is CE marked..

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Phase Two

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Date: Sat Aug 5 10:58 PM, 2006
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Over here in the west we have a custom which involves saying the words "Please" & "Thank you"


Please uses those words when you contact the "centre for sight" in the UK or Ferrara Rings in Brazil through their site for the latest, up to the minate information that you want to your satisfaction.


The contact info. can be found very easily by looking through this section for people such as yourself who needs spoon feeding.



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