Feedback on Tetraflex IOL Please

[APN]

Hi Everyone!

Very recently (a few months back) I discovered during a standard eye examination that I have nuclear cataracts in both my eyes.  Now I know why I get these terrific halos and stars when I look at lights!  :)

I'm a 41 year old man living in the UK.  I am myopic - -4.75 in both eyes.

I have seen a surgeon, and after talking through the options have decided to go for the Tetraflex IOL in both eyes.  

I work with computers and do a great deal of reading, and I can't stand the halos, misting, starring etc. I get at the moment with the cataracts.  When he mentioned to me that some of these effects were possible with Restor, it put me right off any type of multi-focal - so accomodating seems the best choice.

The only other lens that compares to the Tetraflex (as far as I know) is the Crystalens.

I have done a great deal of research on the web etc., but there is not a great deal of info on the Tetraflex - although what I have read seems quite positive.

I would very much appreciate any comments on the Tetraflex and the quality of sight it offers - especially the intermediate (computer distance) and reading vision quality.  Any comparisons to the Crystalens would be appreciated as well.

Many Thanks,

Adrian.

[peakhope]

I'm not sure how similar the experience would be to Crystalens, but you can see my Crystalens HD experience: http://www.medhelp.org/posts/show/764554

and something of a followup in a post in this thread:
http://www.medhelp.org/posts/show/779456?personal_page_id=346980&post_id=post_4066658

When I went in for my 5-day checkup on my first eye, the doctor said everything was coming along fine. I had a lot of faith in him, so went ahead with the second eye two days after that. It worked for me, but I wouldn't recommend that kind of trust for everyone.

[steveWaterloo]

I am 48 and have cataracts in both eyes. I went for the Tetraflex lens transplant in my right eye last week. March 4/09 here in Ontario Canada. I am going again on March 17th for my left eye. My eyes have been bad for most of my life. I have been wearing bifocal contacts lens successfully until the cataract in my right eye starting impairing my vision. I had a 7 diopter lens put into my right. It has not been a week yet but my vision is okay. Midrange is good, distance is slightly blurry and I need reading glasses to read. Which I needed before with my bifocal contact lenses anyways. I do a lot of reading for my job and I am worried about getting both of them done two weeks apart. I am going to ask the Doctor at my checkup tomorrow about my concerns. Does anyone else have a more detailed time line on how their vision changed and a weekly basis?

[saltspringer]

Tetraflex lenses are what Dr. Brierly of Victoria British Columbia implants,so they must be approved in Canada, too. I am sixty, don't have cataracts, but can't stand wearing glasses any more. I'm getting lens replacement.

[tommy47]

3/4 weeks ago I had tetraflex IOL accommodating lens implants.

The right eye is almost perfect SPH  -0.25     Near +1.75 but the left is
                                             SPH -1.50      Near +1.75

Is this good enough especially the left eye.
I do have some astigmatism in the left eye but thi,s,I believe can be remedied by simple Laser Treatment.

Tom

  

[CharlotteinWeimar]

I had Tetraflex lenses implanted in 2006 in the UK with excellent results.  I documented the procedure in a series of watercolours which I have published as a short movie on YouTube.  Go to

CharlotteinWeimar's Channel

I am an artist and can draw paint and drive without glasses.  I only need specs to read small print in low light.

from Yvonne,   in Cornwall UK

[redrocksgal]

I am considering lens replacement surgery due to presbyopia (I am 49 years old).  Have been researching this and was very glad to find your comment regarding upcoming new technologies.  Where can I find out more about the new 2 part lenses you refer to?  I see the wisdom in waiting for better lenses to come out, but I don't want to wait 5 years (perhaps 2 or 3?)  Any idea when these new lenses will be trialed?  Where do you get your information regarding these new lenses?  Thanks so much.

[hootgibber]

Hi Sonya

I think the Tetraflex is the best lens currently on the market, the FDA has pushed the approval date to 2009 due to insufficient enrollments in the study. The fact that it is approved in Europe and not the USA is really due to marketing, which seems to dominate in cataract competition, not necessarily on surgical successes. I am confident that it will be approved, but by that time there are some fabulous developments currently underway that you might want to wait for if you can. The recent development of 2 part lenses where the front section is later laser-tuned is probably the most exciting development, and may be able to deliver outstanding vision. The problem for me was that waiting was not an option, so I went with the best option I could find. If you can see and only need minor help (lenses/contacts etc), both of my Opth surgeons say wait, cause the next gen is going to be better.
Best luck
hootgibber

[JodieJ]

There's an additional reason for passing up the program that I didn't mention.  There has been rapid technological advancement in the area of multifocal/accommodating IOLs, with many promising lenses currently under development.  By the time you do need cataract surgery, there will certainly be better lenses available.  

[JustLittleOleMe]

Thank you SO much for your kindness in warning me. I also found out the program is NOT totally free, only the lens. I have decided not to go through with it. I see GREAT, both distance, mid, and up close with my present contacts (when I get a new prescription as I lost the latest lens and was using a probably 10 year old lens).  I had not considered that everything would not go wonderfully well and I may have not have 20-20 at all ranges. I had also not considered there could be future problems. Thanks SO much for helping someone who is not an authority in these areas. Guess it all sounded too good to be true and FREE. ;-)
Blessings to you all,
Sonya

[JustLittleOleMe]

Thank you SO much for your kindness in warning me. I also found out the program is NOT totally free, only the lens. I have decided not to go through with it. I see GREAT, both distance, mid, and up close with my present contacts (when I get a new prescription as I lost the latest lens and was using a probably 10 year old lens).  I had not considered that everything would not go wonderfully well and I may have not have 20-20 at all ranges. I had also not considered there could be future problems. Thanks SO much for helping someone who is not an authority in these areas. Guess it all sounded too good to be true and FREE. ;-)
Blessings to you all,
Sonya

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

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[cdn_glenn]

The decision is yours Sonya.  You are proposing to have a "clear lens exchange": cataract surgery before you really need surgery.  Take your time before you decide.  Once surgery is complete your vision will never be the same.  It may be better or may be worse, or some of each depending on a multitude of conditions.  I have undergone a clear lens exchange.  In many, many ways I am functionally better than I was with bifocals.  Distance and near vision are both excellent.  Mid vision is lacking, but workable.  I work fine at arm's length, but cannot read fine type.  This surgery was done outside North America.  The lens implanted was not approved in North America, but was approved and in use in Europe and Asia.  I am very happy with the results.

As hootgibber said above, Tetraflex IOLs are approved in the UK and have had excellent results there.  They are not approved in the US.  I cannot comment on future medical care and costs if there are problems with these lenses.  I don't see this mentioned in your post.  You should definitely find out more.

My ophthalmologist of many years made a simple comment when I asked him about such surgery.  He said, "It depends on how much of a risk-taker you are."  I had been considering this for six months and considered it for another six before going ahead.  January 15th would be too quick for me to decide.

[JodieJ]

In your place, I would say NO to the TetraFlex.  Why take on the risks of cataract surgery unnecessarily?  In addition, you would be getting an implant not yet approved, with unknown long-term effects.  I'm sure that Dr. Gills is a fine surgeon, but I doubt that he would want his wife (or mother, close friend) to be part of this study, especially if s/he DID NOT NEED CATARACT SURGERY YET.  BTW, your Medicare will pay for your cataract surgery when you do need it.  You sound like a great candidate for monovision with aspheric IOLs (or with whatever the latest approved technology may be.)  Best wishes.  

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

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[JustLittleOleMe]

I have been chosen to be part of a study with Dr. James Gills (of St. Luke's in Tarpon Springs, FL who has done more cataract surgeries that anyone in the world) on the TetraFlex IOL. This means I get the lenses free to be part of the study for approval by the FDA.
I have worn hard lenses for 47 years, with the past 27 being with gas perms with monovision. I am 67 years old, in good health, but have very baby cataracts in both eyes, but these do not affect my vision. I have 20/20 up close in the left eye, without any accommodation, but if this eye were corrected, I would need accommodation.

Of course, I am concerned about using a lens that has not been approved by the FDA, but I trust Dr. Gills with almost anything. He is an amazing man in every respect.
Please let me know if you feel this would be good for me. I think it would be a fabulous experience to never have to wear contacts again. I go back to him on Jan. 15. Any help, leads, or insights would be greatly appreciated.

Many thanks,
Sonya

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

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[hootgibber]

Hi

If you are in the UK, you are in luck, the Tetraflex is approved there for cataract replacement. I was just there in November, and had bilateral IOL replacement with Tetraflex. The surgery was uncomplicated and quick, and the results have been really great. I have found that I have super distance vision, and close vision depends on how tired I am. 7 days after surgery I tested 6/4 and j4, and 30 days later, 6/4 and j2/j3. The most important thing is to retrain your eyes to read close, and do it a lot to really build up accomodative muscle. I use some 1x readers to read very very small type, especially under low light, and for when I am tired or have to read for a very long time. I am only 6 weeks out, but the results have been great. My consultant OPTH has put in about 300 eyes, and has been generally very happy with it. He recommends bilateral implantation, and I have to say that a week of experience with only 1 Tetraflex lens was very disorienting.

The best advice I can give is to have realistic expectations, OPTH are all scared that we want the very best results (and we do!) but our expectations are ahead of the technology, and they get the blame. I am quite pleased with my outcomes, and recommend the Tetraflex highly.

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

You are welcome. Good luck and Merry Christmas.

JCH III MD

[APN]

Dear Dr. Hagan,

Many Thanks for your reply - it is very much appreciated!

Reading your comments re. multifocal IOL's only re-inforces my opinion (from the research I've done) about them.  That is why I have decided on the Tetraflex lens.  The Crystalens was another option, but it would appear that the design / surgery involved for the Tetraflex is simplier and the quality of vision is at least comparable.

Thanks again for your time,

Adrian.

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

In the US I believe the tetraflex IOL is still in clinical trials while in Europe its no longer in trial. There are many, many unhappy posters her due to multifocal IOLs.  The main disadvantages: extra cost, extre risks, extrachance of having to have an IOL removal/exchange, poor night vision, need to wear glasses some or most of the time.

This is a recent study I found:

Visual Performance Results after Tetraflex Accommodating Intraocular Lens Implantation
Donald R. Sanders, MD, PhD, Monica L. Sanders, BS

Received 14 August 2006; received in revised form 6 December 2006; accepted 10 December 2006. published online 16 March 2007.

Available online: March 16, 2007.

Purpose
To present the clinical results that demonstrate the efficacy of the Tetraflex accommodative intraocular lens (IOL) in providing both enhanced distance and near acuity.

Design
Single-center prospective data collection performed in Manchester, United Kingdom.

Participants
A series of 95 eyes of 59 patients implanted with the Tetraflex lens was performed by a single surgeon. Thirty-six of these cases were implanted bilaterally.

Intervention
Implantation of the Tetraflex accommodative IOL.

Main Outcome Measures
Prospective data collection included both uncorrected distance visual acuity (UCDVA) and uncorrected near visual acuity (UCNVA) testing, manifest refraction, best-corrected distance visual acuity (BCDVA), distance corrected near visual acuity (DCNVA), and the amplitude of accommodation. Intraoperative and postoperative complications also were reported.

Results
At 6 months after surgery, 63% of all cases achieved a DCNVA of 20/40 or better. Virtually all of the patients had at least 1 diopter (D) of accommodative amplitude (98% at 1 month; 100% at 3 and 6 months); 75.7% had at least 2 D at 6 months after surgery. At 6 months or later, 92.2% had 20/40 or better UCDVA. The proportion of cases achieving a UCNVA of 20/40 or better remained relatively constant at 45% to 47%. At 6 months and later, 98.7% had a BCDVA of 20/40 or better. In the bilaterally implanted series, at 1 month after surgery, all patients had at least 1 D of accommodative ability; 96% had at least 2 D at 6 months. One hundred percent achieved a BCDVA, 89.3% achieved a DCNVA, and 74.1% achieved a UCNVA of 20/40 or better at 6 months after surgery.

Conclusions
The Tetraflex accommodating IOL provides enhanced near vision with good distance vision 6 months after surgery.

JCH III MD