Tetraflex versus Crystalens HD IOL

[rwbil]

I am a 47 year old male with cataracts.  From everything I have read, there seems to be too many problems associated with the non-adaptive multifocal IOL's such as Restore and Rezoom.  I would only be interested in the Adaptive IOLs such as Crystanlens HD or Tetraflex.  I read an article that said the Tetraflex was expected to be FDA approved by the end of 2008, but my understanding is so far it is not FDA approved.  I can only find reference that it is in Phase III trials.  Does anybody have any information on the status of the approval (expected FDA approval date)  and if there is a website tracking its approval process and trial results.

Also, does anybody know of any independent (not paid consultant) sources that compares the effectiveness and issues of the two lens, such as an eye doctor who has treated patients with both lens.  Any personal experience would also be appreciated.

Lastly, does anybody know of any other adaptive IOLs that are expected to get FDA approval in the next year or so that is expected to be superior to either the Crystalens HD or Tetraflex lens.

Thanks in advance,
Robert

[John C Hagan III, MD, FACS, FAAO]

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[Whiteout77]

Has anyone had the new Crystalens toric lens implanted?  My doctor wants to put that in my eye.  My surgery is coming up in a couple of weeks, so I need to decide whether or not to go forward with that right away.

[scarlettttt]

Hi,
Acrysof Toric versus Acrysof ReStor. I can't figure it out so I looked up as much info on the accomodating Tetraflex as I can find.
I think I'm going to go with the Tetraflex in ONE eye only. The worst eye. My doctor does not use the Crystalens and I have no idea why. I can't even speak to him until Dec 14
All of my conversations have been with the counsellor and she is the one that does her best to answer my endless questions. She did tell me that although Dr. Gimbel USES the ReStor....all of their patients have hated it. I'm dying to ask Dr. Gimbel why Tetrafex IOLs are available if Crystalens IOLs are not. Sorry...Crystalens ARE available...The Gimbel Eye centre just refuses to use them.
That tells me that in his opinion Crystalens does not work well for his patients.
Believe it or not...he puts his patients before his income and has performed 100s perhaps 1000s of surgeries on people that could not afford it.
He's been listed as one of the 25 Most Influential Opthamologists of the 20th Century.
I am going to meet with him, let him know what I'd prefer but ultimately I'll go with what he believes is the best choice for my situation.
When I had my RK surgery done in 1989 the surgery was in the VERY early stages yet I ended up with 20/15 vision in both eyes and NO astigmatism.
Way back then....the cost was $2500 per eye and I've had many people ask me why didn't I wait for the cheaper Lasik which costs on average $1200 per eye.
My answer to them is that having perfect vision earlier to me was priceless.
I trust this Doctor and maybe he'll tell me that ANY Lre surgery wouldn't be right for me at this stage and if he does....I'll be upset of course, but until he does, I'm going for the Tetraflex as soon as possible.
Regards,
S

[John C Hagan III, MD, FACS, FAAO]

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[londonbridge]

One comment about getting a newly approoved version of anything. I waited three years for the Restor lens to be approoved in my power -8.00 myope. After having the lens placed and then explanted and replaced with a monofocal torric Acrysof I can say that I wish I had carefully studied the research data on this lens. The number of patients that were used to study the effectiveness of this lens was not that high. All of the bugs were not worked out. Newer was not better in my case. Monofocals have been around a long time and have the least problems. I had my first eye which is non dominant set for intermediate and will eventually have my dominant eye, which now wears a contact lens, set for distance. This allows me a fairly full range of vision. I wear reading glasses for when I need close up.
Think twice and consult several experts in using these premimun lenses before deciding.

[suzanne_h]

Robert,

I too am a patient trying to get information on the Tetraflex.  My ophthalmologist was one of the doctors participating in the Phase III trials.  He implants all of the well known IOLs, including Crystalens.  I was told that he prefers the Tetraflex in many instances.  However, each patient's needs are different, so there's no one answer for everyone.  As for when the Tetraflex will be approved, I haven't been able to get any information on that.  I am certain it will be approved.  It is already approved in most other countries.  Lenstec has just completed a 20,000 sq. ft. manufacturing facility in Barbados, which will produce the lenses in quantities sufficient to satisfy the expected demand in the U.S. market.  You might be able to get more information by calling Lenstec directly.  

[John C Hagan III, MD, FACS, FAAO]

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[peakhope]

Part of the reason I chose to get Crystalens HD's now was because they are a small tweak to the 50 platform, which was a modest redesign of the 45. So by now it's a fairly mature technology and you can find doctors who know it well.

A 2007 article had stats on the Tetraflex, and the near-vision numbers seemed less impressive than for the HD (I didn't do a detailed comparison).

[John C Hagan III, MD, FACS, FAAO]

I just now read an article on advances in "premium" IOLs and they really had no idea how long it will take for the aspheric tecnis multifocal IOL to be released. It's always a **** shoot with the FDA.

JCH MD

[JodieJ]

FDA approval can be unpredictable.  The multifocal Tecnis was supposed to have been approved here a couple of years ago--if/when it eventually does get FDA approval, it may already be obsolete technology.  I wouldn't expect to see any independent studies comparing the Tetraflex vs. Crystalens any time soon.

Dr. Oyakawa is a big fan of the Crystalens HD.  (See recent threads.)  He advises finding a surgeon who is very experienced with this IOL.  Monovision (or mini-monovision) with aspheric IOLs is another good option.