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Feedback wanted on Crystalens
I am considering Crystalens and would like to hear from anyone who has had it for the purpose of vision correction not cataracts. I am 43 and have been told that I am a good candidate since I am not a candidate for Lasik but have also been told noboby my age should have it done. I'm confused.
excellent post from the Sales and Marketing Department of AMO, eyecu.
In an attempt at fairness, I would like to clarify that AMO was successful in being the first applicant for this NTIOL status for the Tecnis monofocal lens. This goes into effect Feb. 27, 2006, by which time Bausch and Lomb and Alcon will have their NTIOL submissions approved for their respective aspheric IOL designs. (B&L's AO, Alcon's IQ). Also worth noting is that Staar Surgical received NTIOL status for their astigmatism-correcting (toric)IOL a few years ago, and that design failed miserably due to poor performance. The Array was also a NTIOL and sold for $195 and created a bigger niche than the Staar, but is now on the trash heap. Rezoom is the an acrylic Array with the optic devoted to more distance than near vision. But so are all monofocals.
In an attempt at fairness, I would like to clarify that AMO was successful in being the first applicant for this NTIOL status for the Tecnis monofocal lens. This goes into effect Feb. 27, 2006, by which time Bausch and Lomb and Alcon will have their NTIOL submissions approved for their respective aspheric IOL designs. (B&L's AO, Alcon's IQ). Also worth noting is that Staar Surgical received NTIOL status for their astigmatism-correcting (toric)IOL a few years ago, and that design failed miserably due to poor performance. The Array was also a NTIOL and sold for $195 and created a bigger niche than the Staar, but is now on the trash heap. Rezoom is the an acrylic Array with the optic devoted to more distance than near vision. But so are all monofocals.
bbd- An NTIOL (New Technology IOL) is defined as an IOL that CMS(Center for Medicare and Medicade Services) determines has been approved by the FDA for use in the labeling and adverstising the IOL's claims of clinical advantages and superiority over existing IOL's with regards to reduced risk of intraoperative or post operative complication or trauma, accelerated postoperative recovery, reduced astigmatism, improved post operative visual acuity, more stable postoperative vision or other comparable clincial advantages.
In a final notice published in the Federal Register, CMS stated, "CMS approves AMO's claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis lenses models Z9000, Z9901 and ZA9903 to meet the NTIOL definition and are to be given new NTIOL classification of Reduced Spherical Aberration".
The Tecnis IOL is the only lens approved for NTIOL. "Tecnis NTIOL status confirms the unique design of the lens and the very real benefits it provides to patients" said Dr. Ralph Chu, a cataract refractive specialist in private practice in Minneapolis and an early adopter of the Tecnis IOL technology. "The unique modified prolate technology increases the patients functional vision in varying light conditions, which is critical for every day tasks conducted in low light conditions such as reading, diving at night or in the fog."
Dr. Mark Packer, clinical assistant professor of ophthalmology at the University of Oregon and clinical study investigator for several Tecnis IOL studies, including a driving simulation study said, "The Tecnis lens is the only IOL available that was specfically designed, based on wavefront measurements of a representative sample of the population, to fully compensate for the spherical aberration of the cornea."
Dr. Michael Colvard, and eye surgeon in Encino, CA with over 20 years of clinical practice and speciality interest in IOL technology and cataract surgery added, "The Tecnis IOL, which takes into consideration the importance of correction of spherical aberration with cataract surgery, is one of the truly major advances in intraocular lens technology over the past two decades."
Dr. R. Bruce Wallace, III, cliinical professor of ophthalmology as LSU Medical School stated, "We have a number of our Tecnis patients comment on their enhanced vision at night and in other low light conditions, adding a margin of safety to their activities, espcially for driving.
An analysis by the Potomac Institute for Policy studies states that improved driving performance from reduced spherical aberration with the Tecnis lens could translate into annual preventable costs of automible accidents raning from $450 million in 2004 up to 2.4 billion by 2014.
This information came off a press release on AOL and can probably be found on any of the financial websites.
I would just work with your doctor and take your time if you are not pushed. Techology will move forward and offers so much more today then yesterday. My dad is very happy with the Array lens. Could he be happier with the newer ones. Probably. But he has better vision now than he did before and that what counts. There are happy patients with all lenses. The most important thing is working with you surgeon to try to determine which one would be best for you. There is a website that a surgeon has which is pretty cool and shows the pro's and con's of all the lenses. I think it is a Dr. Harvard in California.
In a final notice published in the Federal Register, CMS stated, "CMS approves AMO's claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis lenses models Z9000, Z9901 and ZA9903 to meet the NTIOL definition and are to be given new NTIOL classification of Reduced Spherical Aberration".
The Tecnis IOL is the only lens approved for NTIOL. "Tecnis NTIOL status confirms the unique design of the lens and the very real benefits it provides to patients" said Dr. Ralph Chu, a cataract refractive specialist in private practice in Minneapolis and an early adopter of the Tecnis IOL technology. "The unique modified prolate technology increases the patients functional vision in varying light conditions, which is critical for every day tasks conducted in low light conditions such as reading, diving at night or in the fog."
Dr. Mark Packer, clinical assistant professor of ophthalmology at the University of Oregon and clinical study investigator for several Tecnis IOL studies, including a driving simulation study said, "The Tecnis lens is the only IOL available that was specfically designed, based on wavefront measurements of a representative sample of the population, to fully compensate for the spherical aberration of the cornea."
Dr. Michael Colvard, and eye surgeon in Encino, CA with over 20 years of clinical practice and speciality interest in IOL technology and cataract surgery added, "The Tecnis IOL, which takes into consideration the importance of correction of spherical aberration with cataract surgery, is one of the truly major advances in intraocular lens technology over the past two decades."
Dr. R. Bruce Wallace, III, cliinical professor of ophthalmology as LSU Medical School stated, "We have a number of our Tecnis patients comment on their enhanced vision at night and in other low light conditions, adding a margin of safety to their activities, espcially for driving.
An analysis by the Potomac Institute for Policy studies states that improved driving performance from reduced spherical aberration with the Tecnis lens could translate into annual preventable costs of automible accidents raning from $450 million in 2004 up to 2.4 billion by 2014.
This information came off a press release on AOL and can probably be found on any of the financial websites.
I would just work with your doctor and take your time if you are not pushed. Techology will move forward and offers so much more today then yesterday. My dad is very happy with the Array lens. Could he be happier with the newer ones. Probably. But he has better vision now than he did before and that what counts. There are happy patients with all lenses. The most important thing is working with you surgeon to try to determine which one would be best for you. There is a website that a surgeon has which is pretty cool and shows the pro's and con's of all the lenses. I think it is a Dr. Harvard in California.
To bbd
I think you should seek the opinion of an ophthalmologist that does all 4 ReSTOR, ReZoom, crystalens, Tecnis monofocal, and get info on the progress of the clinical trials for the Tecnis multifocal from someone other than our financial advisor and buddy HUD...
To your question, I think the vision will be better with a lens implant than a MF contact lens. With the CLs you have external eye issues, fit, movement of the CL, eye irritation, allergy/ environmental issues. Plus as we get older, (starting around age 40) even if we do not develop cataracts, our natural crystalline lens gets thicker and harder so we have distortion and changes in our vision anyway. There are some patients that do opt to get multifocal in one eye and monofocal in the other eye, especially when it is Tecnis. Years ago, our patients that had Array in one eye and a monofocal didn't do as well, but with the improvements with the technologies (ReZoom and ReSTOR) that is not so much of an issue anymore. Also, it is possible to get a monofocal and then later get a piggyback or another lens on top of the existing one, that is Multifocal. That is where AMO has a definite advantage over Alcon because of the advantage of putting two different materials in the eye. (Silicone - Acrylic) vs (Acrylic - Acrylic). My point is that if you desired Tecnis in one eye and a multifocal in the other eye and you later decided you prefer the MF eye, you could have the Tecnis exchanged for a MF or a MF piggyback on top of your Tecnis. You mention intermediate vision, that would weigh towards ReZoom than ReSTOR for your MF eye. Lots to ponder. I ponder daily because I am contemplating the same thing myself as I have previously mentioned.
I think you should seek the opinion of an ophthalmologist that does all 4 ReSTOR, ReZoom, crystalens, Tecnis monofocal, and get info on the progress of the clinical trials for the Tecnis multifocal from someone other than our financial advisor and buddy HUD...
To your question, I think the vision will be better with a lens implant than a MF contact lens. With the CLs you have external eye issues, fit, movement of the CL, eye irritation, allergy/ environmental issues. Plus as we get older, (starting around age 40) even if we do not develop cataracts, our natural crystalline lens gets thicker and harder so we have distortion and changes in our vision anyway. There are some patients that do opt to get multifocal in one eye and monofocal in the other eye, especially when it is Tecnis. Years ago, our patients that had Array in one eye and a monofocal didn't do as well, but with the improvements with the technologies (ReZoom and ReSTOR) that is not so much of an issue anymore. Also, it is possible to get a monofocal and then later get a piggyback or another lens on top of the existing one, that is Multifocal. That is where AMO has a definite advantage over Alcon because of the advantage of putting two different materials in the eye. (Silicone - Acrylic) vs (Acrylic - Acrylic). My point is that if you desired Tecnis in one eye and a multifocal in the other eye and you later decided you prefer the MF eye, you could have the Tecnis exchanged for a MF or a MF piggyback on top of your Tecnis. You mention intermediate vision, that would weigh towards ReZoom than ReSTOR for your MF eye. Lots to ponder. I ponder daily because I am contemplating the same thing myself as I have previously mentioned.
The tecnis monofocal has an aspheric optical design like the Bausch and Lomb AO lens, and the Alcon IQ. These new technology lenses improve the sharpness of your vision when the pupil is larger.
This feature is being added to the diffractive multifocal created by 3M to become the Tecnis multifocal. 3M sold the rights and the name "Restor" to Alcon, who took the diffractive concept and apodized it, but limited the diffractive portion to just the center of the lens optic. Alcon patented this treatment, and then sold the rights to Pharmacia/Pfizer, who then sold to AMO. 3M's study results showed a 59% spectacle freedom, with significant unwanted effects, due to the diffractive portion going all the way out to the edge of the lens (creating a lot of glare and halos). Alcon took 17 years of R&D to revise the 3M lens to the current day ReSTOR, which the FDA study patients show 80% spectacle freedom, with minimal glare and halos. For comparison, AMO's Rezoom, did not have to submit study data to the FDA for approval, saying it was a minor change from it's predescessor, Array, which reports a 41% spectacle freedom. Rezoom is an acrylic version of the Array with more distance vision enhancement.
What might be worth waiting for is ReSTOR IQ, the aspheric version of the presbyopia correcting ReSTOR with blue-light and UV filtering. But this is somewhat like deciding when to upgrade your computer, as technology keeps getting better.
To answer your question about when the Tecnis Multifocal might be available, it won't be until sometime in 2007, maybe 2008.
This feature is being added to the diffractive multifocal created by 3M to become the Tecnis multifocal. 3M sold the rights and the name "Restor" to Alcon, who took the diffractive concept and apodized it, but limited the diffractive portion to just the center of the lens optic. Alcon patented this treatment, and then sold the rights to Pharmacia/Pfizer, who then sold to AMO. 3M's study results showed a 59% spectacle freedom, with significant unwanted effects, due to the diffractive portion going all the way out to the edge of the lens (creating a lot of glare and halos). Alcon took 17 years of R&D to revise the 3M lens to the current day ReSTOR, which the FDA study patients show 80% spectacle freedom, with minimal glare and halos. For comparison, AMO's Rezoom, did not have to submit study data to the FDA for approval, saying it was a minor change from it's predescessor, Array, which reports a 41% spectacle freedom. Rezoom is an acrylic version of the Array with more distance vision enhancement.
What might be worth waiting for is ReSTOR IQ, the aspheric version of the presbyopia correcting ReSTOR with blue-light and UV filtering. But this is somewhat like deciding when to upgrade your computer, as technology keeps getting better.
To answer your question about when the Tecnis Multifocal might be available, it won't be until sometime in 2007, maybe 2008.
I'm reading with great interest everyone's comments on the IOLs currently available. I'm 51, have have posterior sub-capsular cataracts, and have been told that I could do the surgery pretty much any time now. I'm still correctable to 20/20 distance during the daytime, but the glare test shows what I experience in real life, that my night driving acuity is going downhill. Still legal at this point though, so I have a little time.
I'm intrigued by the tecnis MONOFocal lens, and their claims for increased contrast sensitivity, and enhanced night driving vision. I presently wear multifocal contacts which do a pretty good job at all distances. Good enough that I never wear readers, and I still see pretty well for distance. I would really miss not having near and intermediate, however, if I didn't do something else in addition to the tecnis monofocal. To that end, I've been considering this plan: tecnis monofocal (not monovision; I tried that with contacts and didn't like it), + RGP contact lenses for near and intermediate, or maybe in the evenings when I want to ditch the contacts, spectacles for near and intermediate. My thought is that at the present time, perhaps one is better off taking an a la carte option, rather than trying to find an IOL that does it all. I'm just not hearing a lot about folks who are committed to the multifocal contact (mine presently are RGP, which I understand gives better acuity than soft) after IOL implantation. Could it really work? Assuming the IOL power for distance was spot on, and IOL alone gave 20/20 distance, would the presence of a "plano" distance portion of a multifocal RGP contact act as a refracting element on its own? So do you have to plan for this approach in selection of the IOL distance power?
Alternatively, the tecnis monofocal + another surgical correction for the near and intermediate? I don't know much about what that would entail.
All that said, I also am interested in the tecnis MULTIfocal, not yet FDA approved. Does anyone know how that's coming along, and when approval might be granted? Another surgeon I've consulted was among the docs doing the FDA trials for that IOL. Is it likely that the multifocal will retain the same characteristics that the monofocal has with respect to contrast sensitivity and enhanced night driving vision? This same doc implants restor, rezoom, and crystalens, in addition to tecnis monofocals, so with him, I'd have lots of options. Right now, I'm exercising my option just to wait until either my vision deteriorates to an unacceptable level, or my research heads me unequivocally in one direction. Thank you to those of you who share your experiences for the sake of those of us trying to learn.
I'm intrigued by the tecnis MONOFocal lens, and their claims for increased contrast sensitivity, and enhanced night driving vision. I presently wear multifocal contacts which do a pretty good job at all distances. Good enough that I never wear readers, and I still see pretty well for distance. I would really miss not having near and intermediate, however, if I didn't do something else in addition to the tecnis monofocal. To that end, I've been considering this plan: tecnis monofocal (not monovision; I tried that with contacts and didn't like it), + RGP contact lenses for near and intermediate, or maybe in the evenings when I want to ditch the contacts, spectacles for near and intermediate. My thought is that at the present time, perhaps one is better off taking an a la carte option, rather than trying to find an IOL that does it all. I'm just not hearing a lot about folks who are committed to the multifocal contact (mine presently are RGP, which I understand gives better acuity than soft) after IOL implantation. Could it really work? Assuming the IOL power for distance was spot on, and IOL alone gave 20/20 distance, would the presence of a "plano" distance portion of a multifocal RGP contact act as a refracting element on its own? So do you have to plan for this approach in selection of the IOL distance power?
Alternatively, the tecnis monofocal + another surgical correction for the near and intermediate? I don't know much about what that would entail.
All that said, I also am interested in the tecnis MULTIfocal, not yet FDA approved. Does anyone know how that's coming along, and when approval might be granted? Another surgeon I've consulted was among the docs doing the FDA trials for that IOL. Is it likely that the multifocal will retain the same characteristics that the monofocal has with respect to contrast sensitivity and enhanced night driving vision? This same doc implants restor, rezoom, and crystalens, in addition to tecnis monofocals, so with him, I'd have lots of options. Right now, I'm exercising my option just to wait until either my vision deteriorates to an unacceptable level, or my research heads me unequivocally in one direction. Thank you to those of you who share your experiences for the sake of those of us trying to learn.
Agree and enjoyed the discussion. All lens have positives and negatives. I simply want people reading this board to examine all options.
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