Crystalens HD Bottom Line

[mmmmpppp]

Hello,

This one is for the doctors who use the Crystalens HD.  It is motivated by my fear of the Crystalens HD engendered by 1) all the bad stories I have read here on MedHelp, and 2) the reported 60 times greater likelihood of complaints on this forum about premium lenses compared to traditional lenses.

A couple questions:

1)  Among your patients whom you considered excellent candidates for the Crystalens HD and in whom you have implanted the Crystalens HD, what percentage have J1 or better distance and intermediate, J2 (or J3 if you think J2 is asking too much) near, are comfortable driving at night as long and as often as they wish, and would not report any major unpleasantness associated with the lens?

2)  Among your patients whom you considered excellent candidates for the Crystalens HD and in whom you have implanted the Crystalens HD, what percentage do you believe in your heart of hearts has serious doubts or actual regrets about having chosen this lens?

If Crystalens HD had been on the market longer, I would be asking these questions about the one year or greater mark.  Please do not include patients' premature doubts or regrets that pass.  Only feelings that are likely to persist.  Also, if the implant(s) was (were) recent, but you reasonably forsee that the patent will reach the threshold in question 1), please count that patient as reaching that threshold.

Please indicate if your answers to these questions coincide with what you would advise a patient you consider to be an excellent candidate for a Crystalens HD.  In other words, are you confident that you have implanted enough Crystalens HDs to expect in the future what you have seen so far?

By the way, I personally am 51 with a 20/25 left eye with either no cataract or just a beginning one and a right eye that is essentially blind from a big, dense PSC cataract.  So I personally would be especially interested in the answers to the above questions as they pertain to a cataract in just one eye.

Thanks in advance.  This is a wonderful forum.

[mmmmpppp]

I reported mine as "Crystalens Result."  Not perfect, but miraculous!  :)

[Glad4Help]

mmmmpppp, I just realized you were to have your surgery on 7/7.  Did you get the Crystalens?  How did it go?

I just reported my surgery and postop experience under "Great Results with Aspheric IOL" in the Eye Care Community forum.

[Glad4Help]

Without seeing all the data they collected, it's hard to tell why they chose that criteria for analysis but, depending on what part of a sample one analyzes, one can report different outcomes that may be more favorable to one's product.  A good researcher would analyze and report on the WHOLE sample.  Most marketing folks would try to keep it positive though and analyzing only part of the data is a way to do it.  

The Freedom of Information Act is what allows journalists to get information.  I don't know the particulars of how to file or how much info you can get as a result.

BTW, I had the B & L Softport LI61AOV aspheric IOL implanted a week ago and I am seeing great with it.

[mmmmpppp]

My experience with Bausch and Lomb was disturbing.  Since I now have their product in my eye, I have to hope that they are like the solid citizen who nevertheless feels compelled to act in a sleazy way to convince people that they are a solid citizen.  It ought to be part of the FDA process that more than advertisement sound bites be made available from its studies, especially when the researchers promote the product.

But having said all that, could it be that restricting their study to those within .5 D of target is another way of saying that they were only considering the ones that the doctors didn't botch?  I ask in complete ignorance of what achieving target to within .5 D implies.

[mmmmpppp]

The latest Crystalens studies on the FDA site are for two models back, the AT45 in 2003 or 4.  The FDA told me that I should ask Bausch and Lomb for the HD study.  They also told me that becuase the study was not, or not yet, published, I would have to file a Freedom of Information act claim to get it from the FDA.  When I was told the last part, I thought that I was just being blown off, but maybe it's true.

[Glad4Help]

I guess that's what you can do when you are a big corporation. If the findings were wonderful, one would think that they would make them public fast enough.  

Did you try searching through the FDA website?  I really don't know anything about that.  I tried to find something there a couple of times but didn't have much luck.

[mmmmpppp]

Thanks once again for a great link.  You have a talent for finding them!

Bausch and Lomb finally responded to my efforts to get a copy of the FDA study.  They refused, saying that the study can't be released because it contains proprietary information.

Sounds awfully strange to me . . .

[Glad4Help]

Yeah, There was a statement near the end of the article about the Crystalens FDA study that said they didn't include the other eyes in the sample because it would have skewed the analysis toward more improvment in near vision, but I wonder if it would have also showed less far vision improvment???

Here'a a link to another article that gives statistics for Crystalens:
http://license.icopyright.net/user/viewFreeUse.act?fuid=Mzg2NTE2NQ%3D%3D

Good luck to you with the Crystalens.  My surgeon really seems very excited about his recent results.

I have decided to go with the aspheric monofocal lenses.  I went back to see my eye doctor and he says I will have much better vision than I have now but, of course, will still wear the multifocal glasses, which I have had for several years and like fine. He says I really have to do both eyes to get a proper visual balance.  And he thinks once I get the first eye done that the first question I will ask is 'how soon can I get the other one done.'  

[mmmmpppp]

Thanks for that link!  I too was struck by the appearance that they selected only those with the most successful outcomes on which to base their statistics.  If anyone else reads this post, I wonder if you know why the following statement doesn't nullify the FDA study of the Crystalens HD. When I say nullify, I mean, are the percentages of patients with various visual acuities based on a sample of only the most successful patients?  Here is the quote from the article about the study:

"For analysis of uncorrected and distance-corrected visual acuity VA, we selected patients who achieved a target refraction within 0.5 D of the intended target. We also conducted a comparison of monocular uncorrected and distance-corrected near VA with results of a randomly selected, similar sized group of patients from prior studies of the parent lens, AT-45, and the third-generation Crystalens Five-0."

It looks like not only did they select the plum HD patients, but they compared them to a random sample of patients with the previous versions of the lens.  

I too have been very attracted to the aspheric monofocal, but I guess I am just willing to gamble for the intermediate-without-glasses and maybe even something good on the near front.  But it was a close decision.  I hope I don't regret it.

[Glad4Help]

I really appreciate your input.  And, to tell you the truth, the thought of replacing the good lens in the left eye has given me pause for thought a few times.  I am far from blind in the cataract right eye but do favor that eye for reading, which I do all day at my job as a tech writer.  Actually, it is more annoying than sight critical and I think my reading ability with the left eye is improving, so surgery could wait a while.  I am going to consult with docters some more before taking the plunge.  

[ace399]

I think it has to do with the image size.  An IOL makes the largest image and contacts make a slightly smaller image.  Glasses make the smallest image.  So, an IOL in one eye and glasses in the other eye at a refraction of -6.25D was a mismatch in image size, which was difficult for the eyes to resolve into a single image.

[Glad4Help]

Thanks for the advice.  Do you know why glasses would not work but a contact would?  I haven't worn contacts in years.

[ace399]

I would recomend against replacing a perfectly good natural lens with an IOL, regardless of the type.  However, depending on the refraction difference between the IOL eye and the non-IOL eye, you may need a contact lens on the non-IOL eye.

My refraction was -6.25D in left eye and -6.50D in right eye.  With the CL HD in my right eye and none in my left, I could not wear glasses on my left eye only.  The image size of the left eye was much smaller than the image in the right eye.  A contact would have helped.

[Glad4Help]

Thank you both for your comments.

mmmmppp, I would be VERY interested to see that FDA study on the CL HD if you manage to get it.  I found an article about the study in Othalmology Times--Europe.  Here's the link: http://www.oteurope.com/ophthalmologytimeseurope/Refractive/The-new-generation-Crystalens-better-than-the-rest/ArticleStandard/Article/detail/489479

I thought it was strange that they only used part of the sample for analysis... [those] "who achieved a target refraction within 0.5 D of the intended target."  Wouldn't this skew the analysis to report the best possible results?  It doesn't take into account the eyes with 'missed' prescription measurements, does it?

I'm getting tired of trying to sort out the Crystalens issues.... Makes me nervous.  I've been reading good things about the aspheric monofocal lenses and think I might just get those.  My optomotrist told me I should go ahead and get both eyes done for balance and stick with the standard lenses.  I'm already farsighted with multifocal glasses, so shouldn't be much different.

If I can't make a decision this week, I will have to pospone surgery scheduled for July 8.  I'm supposed to go for pre-op measurements July 1.

[ace399]

Although my experience with one multifocal IOL in one eye and a monofocal IOL in the other is not exactly like one multifocal in one eye and none in the other, it may be a close approximation.

[ace399]

2 to 6 feet would encompass people across a table.  I can see clearly in this range.

When I had the Restor in my left eye and the CL HD in my right eye acting as a monofocal IOL according to my Dr. (since it did not accommodate), I was able to play tennis with no problem.  Then when the CL HD shifted myopic, I had corrective glasses for my right eye (plain glass in my left eye) and still no problem playing tennis.

[mmmmpppp]

Oops!  Left out a sentence in my last post, namely:  Doesn't the Restor focal point extension just mean that near ends at 2 feet instead of 18 inches?  That is, aren't you blurry from about 2 feet to 6 feet?

[mmmmpppp]

How do you get the intermediate vision from the Restor's?

By the way, remember that Glad4Help and I need IOLs in one eye only.  There seems to be evidence that a multifocal doesn't do well in one eye only.

Anyone have any experience with a multifocal in just one eye (and a natural lens in the other)?

[ace399]

I had a Crystalens HD implated in my right eye in Feb 2009 and then the new Restor in my left eye in April 2009, after the CL HD did not accommodate.  Eventually the CL HD shifted myopic.  My Dr. suspects that a slight tightening of the capsule can cause this.  On this Forum, I've seen Dr. O, who has a lot of experience with Crystalens IOL's refer to this as a "myopic surprise."  My Dr. then replaced the CL HD with a new Restor 3 weeks ago.  I now get excellent distance AND internediate vision.  The new Restor has the focal point extended to capture the intermediate range.

I can also read fine print withour glasses in good light, but need readers in dim light.  Never a problem reading the computer screen without glasses.  I play tennis and the two Restors have also helped improve my game.  I do not have any problems driving at night.  From what I can see, the newest Restor must be a big improvement over the older model.

[mmmmpppp]

I opted for the Crystalens HD, but it won't be implanted until 7/7/2009.  I decided that intermediate vision (without glasses) is extremely important to me, and, especially because I am only having it done in one eye, I am expecting to have to wear reading glasses.  I figure that it is relatively "normal" to have to wear reading classes (even though my eyes seemed to reject reading glasses before this cataract issue arose).

I strongly considered mutifocals, namely, Restor and Technis, but read that they are poor in one eye only and are weak in regard to intermediate vision.  I am on the computer 20 hours a day and I wouldn't want it in my face, hence intermediate is extremely important  (The Crystalens HD apparently is not as good in one eye only also, but I think that the effect of one eye only is not nearly so great with the Crystalens and mostly only applies to near vision.  I hope I'm right about that.)

I am attempting to get ahold of the FDA study on the Crystalens HD reportedly of 125 patients with John Hovanesian a principal investigator.  But I am having surprising difficulty, which, yes, is beginning to worry me.  It's not on the FDA website, and someone there (of questionable sincerity) told me that I'd have to file a Freedom of Information Act petition to see it because it has not been published.  I had been emailing John Hovanesian, who was responding until I asked for that study.  I've left messages with some project manager at Bausch and Lomb (supposedly "the right person") and so far have gotten no call back.  I'll let you know if and when I get my hands on it.

BTW, I think Dr. Hagan must put in the blank message to get notified of updates to the thread.  Putting in a blank message on the same day as the original post wouldn't keep it much closer to the top of the Forum.

[ace399]

I think Dr. Hagan does that so the topic can rise to the top of the Forum.  Otherwise it can be buried.

[Glad4Help]

I am feeling exactly how you were in your first post here.  What did you finally decide?  I have to make a decision next week.

I am leaning toward conventional lenses because I am starting to think that Crystalens is just not proven enough...  I have found very few statistics on HD results.  Also, I think I will have to wear glasses anyway if I get Crystalens, so why spend the money.  My doc says he is having very, very good results but gave no specifics, so what does that mean??  Also, he is a consutlant for some Bausch & Lomb equipment, so ,,, you know.

BTW, I see that Dr. Hagan's message above is blank.  I see many from him that appear that way.  Does anyone know why his are like that?  Would be interested in what he has to say.

[peakhope]

I think the Center of Excellence Award is probably a good starting point. I would never make a decision like this based on a single credential, though.

Look, read, ask, listen. This is YOUR health and YOUR decision, so be proactive with your research and be sure to understand all the costs, risks, possibilities, and trade-offs.

[mmmmpppp]

You want your doctor to have a Crystalens Center of Excellence Award, so many have told me.