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Medical Forum / General / Vision / April 2005

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Cure for Cataracts and Presbyopia

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David DeBar - 16 May 2004 19:58 GMT
I just found out about "Crystalens".  It seems everyone but me knows about
these lenses.  A Google search uncovered some information.  Basically it's a
implantable lens like those use in cataract surgery but this lens is on a
hinged support that is attached to the eye muscles that were formally
attached to the natural lens.  After  few weeks the patient learns to move
the lens so he can see close as well as far without eyeglasses.  There are
some limits to the accommodation this lens provides.  You will still need
glasses to read very fine print.

I'm 64 years old and my optometrist tells me that I have the beginnings of
cataracts. She tells me that she is amazed that I can see as well as I do.

I would love to be able to see to drive and see the dash and read a map and
to wake up and see out the window and turn over and clearly see the face
next to me in bed. This sounds too good to be true!

Before I go under the knife I would like to learn a little more:

1)  I would like to hear from a few people you have had the procedure done.

2)  I read that currently the Crystalens optic is 4.5 mm.  If I measure my
own pupil with a ruler in a dim room, I get  about  5 mm.  Is that a
problem?

3) I read in the Internet about another lens under development that uses two
lenses, one positive and the other negative.  How far is this lens from
introduction and what is the advantage of this approach?

4) Who are the doctors with the most experience with this procedure that
have good track records?

I would be willing travel a very long distance and stay in a hotel to have
good experienced doctor perform the operation.
I live in Northern Virginia.

Thank you for any information you can provide.

Dave
BZall - 16 May 2004 21:21 GMT
Dave:

I asked about Crystalens a few weeks back and got no responses.

BZall@aol.com
David DeBar - 16 May 2004 22:10 GMT
I guess we are the only ones in this group who have heard about it?  I would
like to hear from someone who has had it done.

Dave

> Dave:
>
> I asked about Crystalens a few weeks back and got no responses.
>
> BZall@aol.com
LarryDoc - 16 May 2004 21:39 GMT
> I just found out about "Crystalens".  It seems everyone but me knows about
> these lenses.  A Google search uncovered some information.  Basically it's a
> implantable lens like those use in cataract surgery but this lens is on a
> hinged support that is attached to the eye muscles that were formally
> attached to the natural lens.  

The Crystalens is a very new product in the USA  (3 months) and has only
a year or so of usage in Europe.  I've attended a seminar given by a
ophthalmologist who had done the procedure,  who curiously is not on
their list of practitioners that you can view on the company's web site.  
I also had the opportunity to view the procedure and talk with one
patient who had the implant.

I think it's a great idea that needs further development. If we're
looking for a perfect fix for cats and presbyopia, this isn't it but
we're getting close!  The amount of add power that most patients
(remembering the limited post-surgical data) get is not enough to free
them from the use of near vision spectacles and the optics is, as you
wrote, a little too small to best serve the majority of patients,
especially the "younger" demographic.

There are a number of other lenses under development that incorporate
similar mechanics but with different materials. Additionally, combining
this lens with other refractive surgery procedures might further enhance
"the real life working success rate."

I'd suggest a "wait and see" position for at least the next six months
or so, unless you are willing to accept that which this product can
provide for you.

My opinion, of course.  Do check with docs who have done this in your
area and share with us any more info you might learn!

--LB

Signature

Dr. Larry Bickford, O.D.
Family Practice Eye Health & Vision Care

The Eyecare Connection
http://www.eyecarecontacts.com
larrydoc at eye-care-contacts dot com (remove -)

David DeBar - 16 May 2004 22:18 GMT
Dr. Bickford,
Thank you so much for for your knowledgeable reply.  Yes I can adopt a "a
wait and see" or in my case "it's a wait and not see up close" policy for
six months or so.

Thanks

Dave

> There are a number of other lenses under development that incorporate
> similar mechanics but with different materials. Additionally, combining
[quoted text clipped - 17 lines]
> http://www.eyecarecontacts.com
> larrydoc at eye-care-contacts dot com (remove -)
David DeBar - 18 May 2004 14:09 GMT
I spent a lot of time on google last night looking for articles on this
subject.  It looks like there are multiple competing companies coming out
with lens that offer the promise of help for Presbyopia.

Crystalens: has a single moving lens that provides considerable but limited
amount of accommodation.

Synchrony: Has a dual lens system with one lens moving that provides twice
the accommodation of Crystalens BUT there is no prediction when it will be
available in the US or anywhere else.

AMO and Alcon: Both have a multi-focus stationary lens that promises help
with presbyopia.  These lenses do not move but offer "PSUDO"-accommodation.
Alcon hopes to have their lens to market by 2005.

Intuitively it seems to me like the lenses that take advantage or the
muscles in the eye would provide a more natural feel to vision.  These are
very interesting developments.  I hope a clear winner comes to market by the
time I need it, in a year or two.

Dave
Rishi Giovanni Gatti - 18 May 2004 20:59 GMT
> Intuitively it seems to me like the lenses that take advantage or the
> muscles in the eye would provide a more natural feel to vision.  These are
> very interesting developments.  I hope a clear winner comes to market by the
> time I need it, in a year or two.

Intuitively it seems you are a blunt idiot!

Why do you have to wait for these bullshit companies to make such
terrible invetnions instead of learning for yourself how to train the
eye muscles to have your accomodation back?

Who is preventing you?

It's difficult to understand.
David DeBar - 20 May 2004 00:57 GMT
Dear Dr. Bickford,

Thanks again for responding to my post about Accommodive Intraocular Lens'.
Your comments about new materials coming out soon interested me.   I did
some patent research on this topic.  (Patent research is my business.)  I
discovered that dual lens intraocular lenses have been in the patent art for
a long time.  A very recent patent  invented by Son Trung Tran and assigned
to Alcon was issued Sep. 9, 2003.  This is well written patent and cites a
lot of prior art.  Claims 3, 4 and 5 two mentions materials that the lenses
could be made of.  In the body of the patent Tron mentions the problems of
the formation of "posterior capsule opacification" ("PCO").  He explains
that by making the lens out of  hydrogel or soft acrylic problems with PCO
are avoided.  This patent number US 6,616,691 is an interesting
tutorial on this subject.

If you want a copy of this patent I can, at your request, attach it as a PDF
file and email it to you.  You will need to email with a working email your
current one is full.
To email me remove the components of SPAM from around my name at the bottom
of this text.

Dave
----- Original Message -----

> There are a number of other lenses under development that incorporate
> similar mechanics but with different materials. Additionally, combining
[quoted text clipped - 13 lines]
> Dr. Larry Bickford, O.D.
> Family Practice Eye Health & Vision Care
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Robert Martellaro - 17 May 2004 23:28 GMT
>I just found out about "Crystalens".  It seems everyone but me knows about
>these lenses.  A Google search uncovered some information.  Basically it's a
[quoted text clipped - 34 lines]
>
>Dave

http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?i
d=82680

David DeBar - 18 May 2004 02:59 GMT
Thank you Robert, and did you see this:
http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.j
sp?id=93978

Dave

It sounds like the above lens might be better but when the time comes that I
need cataract surgery I'll opt for what is out there and known to work at
the time.  Life is too short to wait for technology under development.

http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.j
sp?id=82680
David DeBar - 18 May 2004 04:38 GMT
Here is another lens under development that the company (Alcon) hope to have
available in the U.S. in 2005.
http://finance.lycos.com/qc/news/story.aspx?symbols=NYSE:ACL&story=200405030
401_PRN__NYM153

said Cary Rayment, Senior Vice President, Alcon United States. "Reducing the
need for reading glasses after lens removal, without compromising distance
vision, has been a goal of ophthalmology for many years, and it looks like
the range of accommodative effect and predictability of this lens may
finally get us there."

Dave
David DeBar - 18 May 2004 05:01 GMT
I spent a lot of time on google tonight looking for articals on this
subject.  It looks like there at least three competing companies coming out
with lens that offer the promise of help for Presbyopia.

Crystalens: has a single moving lens that provides considerable but limited
amount of accomodation.

Synchrony: Has a dual lens system with one lens moving that provides twice
the accomodation of Crystalens BUT there       is no perdiction when it will
be availble in the US or anywhere else.

Alcon: Has a multi-focus stationary lens that promises help with presbyopia.
I hope this works better then the contact lenses that seems to work the same
way.  I tryed the contacts and gave up on them.  Alcon hopes to have this
lens to market by 2005.

Dave
Mike Tyner - 18 May 2004 05:16 GMT
> Alcon: Has a multi-focus stationary lens that promises help with presbyopia.
> I hope this works better then the contact lenses that seems to work the same
> way.

Did you come across the AMO Array Multifocal?

-MT
David DeBar - 18 May 2004 13:49 GMT
Yes, this looks a lot like the Alcon lens.  It does not move but promises a
wide range of "PSUDO"-accommodation

> Did you come across the AMO Array Multifocal?
>
> -MT
Glenn Hagele - Council for Refractive Surgery Quality Assurance glenn.hagele@usaeyes.org - 20 May 2004 01:57 GMT
Whenever you hear of a new miracle, check the previous miracles and
expect something a bit less than miraclous.

Yes, the CrystaLens does seem to be a viable accommodating intraocular
lens (IOL), but there are some very real limitations to its acceptance
in the US.

The haptics of the CrystaLens must be placed in the ciliary sulcus.
Those of you who know the anatomy of the eye understand that this is a
small ridge that encircles the eye just underneath the iris.  If the
lens is not placed in the ciliary sulcus, it may not accommodate at
all.  If it is placed on the zonules, it can cause siginificant
damage.  Some people don't even have the ridge at the ciliary sulcus,
but you can't determine any of this preoperatively because there is no
readily available way to actually look.  Even when implanting the IOL,
the surgeon cannot see underneath the iris to determine if the IOL is
implanted correctly or CAN be implanted correctly.

To say the least, the skill of the surgeon had better be top notch.

Of those who have accommodation, it tends to be about 1.00 to 1.50
diopters.  That is not bad, but nothing to write home about.  Some get
no accommodation at all.  Whether or not the patient will have
accommodation or not cannot be known until after the surgery and
healing is completed.

It seems that CrystaLens is a step forward, but like all first steps,
it is a small step.  Expect continued development and improvement on
accommodating IOLs and the surgical techniques to implant them.

If you talk with patients who have the multifocal
"psydo-accommodative" IOLs, you will quickly learn that you must love
halos to love these particular IOLs.

When the rubber hits the road, CrystaLens and other superior
technology IOLs come to a screeching halt.  Not because of any problem
with the IOLs, but because of problems with paying for the IOLs.

Most US citizens develop cataracts at an age when they are covered by
Medicare insurance.  As a part of the federal government, the Medicare
system has the ability to not only decide what insurance coverage to
provide, but to back it up with civil and criminal penalties.

Medicare determines how much will be paid for an IOL.  No matter how
much the lens actually costs, Medicare will only pay that amount.
This sounds reasonable, but the next point may surprise you.  Even if
the patient wants to pay the difference for a superior technology IOL
such as the CrystaLens, Medicare will not allow it.

If a doctor receives from the patient the actual difference between
what Medicare allows for an IOL and the cost to the doctor for the
superior technology IOL (no profit), the doctor is subject to
significant fines, being kicked out of the Medicare system, and jail
time.

Medicare will not allow a beneficiary to purchase superior technology;
even with the patient's own money and even if the superior technology
is clearly advantageous for the patient.

For this reason, there is very little incentive for manufacturers to
develop superior technology IOLs.  If someone wants the CrystaLens,
that person will be required to pay the entire cost of surgery
including the physician component, anesthesiology, facility, and IOL
out of his or her own pocket - even if the patient has Medicare.

Currently no Medicare supplemental insurance will pay the entire cost
of care to be able to receive superior technology, and none seem too
eager to add this potential liability to their plans.

This is an inequity that affects not only people wanting superior
technology IOLs, but people needing other prosthetics and even
pacemakers.  The federal government will not allow a patient to use
his or her own money to pay the difference and receive superior
technology.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.
The Real Bev - 20 May 2004 02:53 GMT
Glenn, Hagele, -, Council, for, Refractive, Surgery, Quality, Assurance,
glenn.hagele@usaeyes.org wrote:

...
> Currently no Medicare supplemental insurance will pay the entire cost
> of care to be able to receive superior technology, and none seem too
[quoted text clipped - 5 lines]
> his or her own money to pay the difference and receive superior
> technology.

When Jane Bryant Quinn said that that was a GOOD thing because it would
keep dotty elders from being defrauded by evil doctors I stopped reading
her column.

Correct me if I'm wrong, but I believe the doc can also be
medicare-defrocked if he uses the forbidden technology on a medicare
subscriber who pays the full freight without going through medicare.

Signature

Cheers,
Bev
======================================================================
"Steve Balmer, CEO of Microsoft[0], recently referred to LINUX as a
cancer. Unsurprisingly, that's incorrect; LINUX was released on August
25th, 1991 and is therefore a virgo."                       -- Kevin L

David DeBar - 20 May 2004 03:26 GMT
Bev,

I hope your wrong about that.  I guess I could leave the country for my
surgery if I had to.

Dave

> Correct me if I'm wrong, but I believe the doc can also be
> medicare-defrocked if he uses the forbidden technology on a medicare
[quoted text clipped - 3 lines]
> Cheers,
> Bev
David DeBar - 20 May 2004 03:19 GMT
Thank you Glenn for pointing out some of the complications with Crystalens.
In this same thread you will see responce from Dr. Larry Bickford who
advises to take a wait and see for at least six months.  In my responce to
Dr. Bickford I mentioned patent number 6,616,691.  In it mention is made of
posterior capsule opacification" ("PCO").  This is another danger that might
manafest it's self years after the surgery.  In the above Alcon patent it is
claimed that silcone is a problem in that it causes PCO.  On the other hand
the Crystlens people tout their use of silicone.  Who are we to belive?!?!
I just hope that this is better understood by the time I need my cataract
operation.  I can still see 20/20 with my glasses. At 64 years of age I find
that I need multiple perscriptions depending on what I'm doing. I can wait a
while, and will be willing to pay for skilled medical care when I need it.
I recently traveled have way across the country to have the best doctor I
could find operate on my prostate.  He was worth every penny.  I'll do the
same with my eyes when the time comes.

BTW the above patent discribes a two lens device that greatly increases the
amount of accommodation.  Who know when it will come to market or how safe
it will be?!?!  In this patent they say that the lens is, "easily implanted
in the posterior chamber."

Dave
Glenn Hagele - Council for Refractive Surgery Quality Assurance glenn.hagele@usaeyes.org - 20 May 2004 06:21 GMT
>Thank you Glenn for pointing out some of the complications with Crystalens.
>In this same thread you will see responce from Dr. Larry Bickford who
>advises to take a wait and see for at least six months.  

You will find that I firmly believe everyone has a right to my
opinion.

8^)

Here is another one of those tidbits that make one realize just how
little is understood about accommodation - and I'm not just talking
about Schacher v. Helmholz here.

In the CrystaLens FDA prospective clinical trial, 201 eyes were at
least .50 hyperopic.  88% of this group achieved uncorrected near
visual acuity of J3 or better, but that improved to 98.4% when
implanted bilaterally.  That result is consistent with the bilateral
improvement of Schacher's implants when only one eye had the
operation, but seems inconsistent with the improvement found in
Conductive Keratoplasty (CK) for presbyopia.

Hmmm.

>In my responce to
>Dr. Bickford I mentioned patent number 6,616,691.  In it mention is made of
>posterior capsule opacification" ("PCO").  This is another danger that might
>manafest it's self years after the surgery.  In the above Alcon patent it is
>claimed that silcone is a problem in that it causes PCO.  On the other hand
>the Crystlens people tout their use of silicone.  Who are we to belive?!?!

All and none.

It is possible for Posterior capsule opacification (PCO) to happen
with ALL materials.  It happens with polymethalmethacrylate (PMMA),
silicone, acrylic, collamer, hydrophobic acrylic, and hydrophilic
acrylic hydrogel. I suspect that it will happen with the light
adjustable IOL (LA-IOL) that Calhoun is working on.  The only
difference is how quickly it will occur, and even that is debated.

Since PCO does not happen to everybody (there are some who have had
all types of IOLs without PCO) there is the possibility that it is
more an issue of the type of technique used for cataract extraction,
the placement, the manipulation, and/or the physiology of the patient.
Some manufacturers blame PCO on edge design, not on the material.
Some claim a capsular tension ring will reduce or eliminate PCO.  Thus
far, this question has not been fully answered.

If somebody says that PCO will not occur with their IOL, I would be
very unlikely to believe them.

Fortunately, laser posterior capsulotomy is quite successful and
relatively non-invasive.  I need to talk with the CrystaLens people
about how blowing a hole in the back of the bag will affect a forward
vaulting accommodating IOL.  That will be an interesting conversation.

>I just hope that this is better understood by the time I need my cataract
>operation.  I can still see 20/20 with my glasses. At 64 years of age I find
>that I need multiple perscriptions depending on what I'm doing. I can wait a
>while, and will be willing to pay for skilled medical care when I need it.

Time and money are the two luxuries that should be afforded to all of
us when we are 64.  Heck, I'm game at 20 years your junior!

>I recently traveled have way across the country to have the best doctor I
>could find operate on my prostate.  He was worth every penny.  I'll do the
>same with my eyes when the time comes.

It is unfortunate that not all have this opportunity.

>BTW the above patent discribes a two lens device that greatly increases the
>amount of accommodation.  

This is probably the Syncrony Dual-Optic accommodative IOL.  The
results of six (6) patients was presented at ASCRS, but they only
showed distance corrected acuity at 1-2 months postop.  Obviously, not
ready for prime time.  The company is Visogen in Irvine CA.

>Who know when it will come to market or how safe
>it will be?!?!  

When the company doesn't say much, it is hard to guess.

I don't deal much with cataract, but I am involved heavily in
refractive surgery.  Since Clear Lens Exchange (CLE) is becoming in
vogue, I've been brushing up on my IOL technology.

>In this patent they say that the lens is, "easily implanted
>in the posterior chamber."

Yea, "easily".  Think about getting two haptics in the ciliary sulcus
that may or may not exist and is behind the iris that the surgeon
cannot see or even accurately know its diameter.  How these docs
actually do it is one of the great wonders of the medical world.

Also consider the size of these IOLs.  When you need a 6.0mm incision
to implant an IOL, the probability of induced cylinder is possibly
enough to counter any increase in accommodation.  What good is
accommodating if everything is blurred or distorted?

Oh well, they can have LASIK for that...

...and the surgery goes on.

Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.
Dan Abel - 20 May 2004 17:59 GMT
> Thank you Glenn for pointing out some of the complications with Crystalens.

> Dr. Bickford I mentioned patent number 6,616,691.  In it mention is made of
> posterior capsule opacification" ("PCO").  This is another danger that might
> manafest it's self years after the surgery.  In the above Alcon patent it is
> claimed that silcone is a problem in that it causes PCO.  On the other hand
> the Crystlens people tout their use of silicone.  Who are we to belive?!?!

As Glenn mentions in his response to the above, the key is whether the
Crystalens responds to laser treatment the same way other IOLs do.  I've
had cataract surgery in both eyes, five years apart, and in both cases I
got PCO about a year after the surgery.  It's a single office visit to
fix, with no pre or post op visits involved.  You get the eye dilated, the
doctor looks at it, you get set up at the laser machine and then five
minutes later you are out the door.  The longest part of the procedure is
waiting for the eye to dilate.  There is almost no pain or discomfort, and
your vision is perfect by the next day.

Signature

Dan Abel
Sonoma State University
AIS
dabel@sonic.net

David - 20 Apr 2005 02:27 GMT
Do a lot of research, I had the IOL's implanted a year ago and met with a
disappointing result.  At the time I had the surgery I could find no
information on the results of these implants except the advertisements from
Eyeonics.   I found that the glowing remarks and comments were the same on
all of the Doctor's sites performing these implants.

Now I am beginning to see several posts on the internet from patients that
are experiencing disappointing results.
 
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