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Tecnis Symfony IOL Approved by US FDA
Tecnis Symfony IOL receives FDA approval
Abbott Medical Optics (Abbott Park, Illinois) announced that the FDA has approved the Tecnis Symfony IOL for the treatment of cataracts. The Tecnis Symfony lenses are the only lenses in the U.S. that provide a full range of continuous high-quality vision following cataract surgery while also mitigating the effects of presbyopia by helping people focus on near objects, the company said in a press release. The FDA approval includes the Tecnis Symfony Toric IOL. The approval was based on results of a U.S. pivotal study that compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients. Compared with patients in the monofocal group, those who received a Tecnis Symfony IOL achieved greater improvements in intermediate and near vision while maintaining similar distance vision. Patients in the Symfony group were also more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition. Rates of adverse events did not differ between the Symfony and monofocal groups.
Abbott Medical Optics (Abbott Park, Illinois) announced that the FDA has approved the Tecnis Symfony IOL for the treatment of cataracts. The Tecnis Symfony lenses are the only lenses in the U.S. that provide a full range of continuous high-quality vision following cataract surgery while also mitigating the effects of presbyopia by helping people focus on near objects, the company said in a press release. The FDA approval includes the Tecnis Symfony Toric IOL. The approval was based on results of a U.S. pivotal study that compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients. Compared with patients in the monofocal group, those who received a Tecnis Symfony IOL achieved greater improvements in intermediate and near vision while maintaining similar distance vision. Patients in the Symfony group were also more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition. Rates of adverse events did not differ between the Symfony and monofocal groups.
One more new article today by Dr. Loden who did one of the videos I linked above, giving his impression of the various studies of the Symfony:
http://www.medhelp.org/posts/Eye-Care/Tecnis-Symfony-IOL-Approved-by-US---FDA/show/2905194
"High rates of spectacle independence, patient satisfaction seen with Symfony IOL"
http://www.medhelp.org/posts/Eye-Care/Tecnis-Symfony-IOL-Approved-by-US---FDA/show/2905194
"High rates of spectacle independence, patient satisfaction seen with Symfony IOL"
Yes the one post should have been under a thread discussion of light adjusted lens.
The doctor's post above seems to be have been meant for the page about the LAL. Since the Symfony has been approved in the US, I've started to see more American publications writing about it, and interviews with American surgeons. Here are some that might be of interest.
There is a few minute video interview with a prominent American surgeon this week about the Symfony (though oddly done at a European conference) here:
http://ewreplay.org/node/1383?v=5119687196001
Here is a few minute video interview with an American surgeon who went through the various studies of the Symfony regarding things like halos:
http://ewreplay.org/node/1383?v=4884644449001
Here is an article in Eyeworld, from the American Association of Cataract and Refractive Surgeons:
http://www.eyeworld.org/article-new-iol-provides-high-quality-vision-over-extended-range
Another is in Cataract and Refractive Surgery Today:
http://crstoday.com/2016/08/a-new-extended-range-of-vision-iol/
There is a few minute video interview with a prominent American surgeon this week about the Symfony (though oddly done at a European conference) here:
http://ewreplay.org/node/1383?v=5119687196001
Here is a few minute video interview with an American surgeon who went through the various studies of the Symfony regarding things like halos:
http://ewreplay.org/node/1383?v=4884644449001
Here is an article in Eyeworld, from the American Association of Cataract and Refractive Surgeons:
http://www.eyeworld.org/article-new-iol-provides-high-quality-vision-over-extended-range
Another is in Cataract and Refractive Surgery Today:
http://crstoday.com/2016/08/a-new-extended-range-of-vision-iol/
JFD is our internationally known cataract/cornea/refractive surgery:
Well I do not have any irregular astigmatism. I am wearing readers for near and far vision. 1.75 left eye, 2.0 for the right eye. Did any of the patients in your clinical trial experience color perception issues that did not resolve over time?
JFD: no. There is some concern with “ red vision “ or erythropsia but if present this was transient. An issue to be concerned about for sure but in practice was a non-issue. We see this with regular lenses especially if a case goes long. Always is a transient phenomenon.
Are they happy they had the LAL implant?
JFD: Universally yes.
Would you say that cataract surgery causes less dry eye symptoms than Lasik?
JFD: Yes. Anytime one undergoes surgery anywhere on the body and traumatizes a nerve which is anytime someone has surgery there can be symptoms. One of the these is neuralgia which can be experienced by patients after lasik or cataract surgery. Tends to be transient in nature as well.
Sorry for all the questions, but these are considerations I need to take into account. Most importantly, do the trial clinics use the latest "version" of the LAL lens.
JFD: The FDA trial is complete. No cases being done in the US. If a case is done outside the US it is the latest technology in all likelihood. Calhoun only wants the latest most advanced surgery to be performed.
In other words, as Calhoun Vision tweaks the lens for various reasons is that what gets dispensed to the surgeon for use?
JFD: Yes.
For example psbpsbpsb stated that the color red was very pronounced after adjustments and lock in procedures, also that the color green looks washed out. Is Calhoun working on lessening those affects and if so are those generation of lenses being sent to the Drs. in the approved countries and to the clinical physicians?
JFD: Not sure what psb is? PBS?? What you cite in first sentence is transient. Even within the study we modified the optics to minimize the erythropsia. I never had a complaint nor heard of a single patient from the other centers having a green desaturation. Not saying it didn’t happen in US or OUS but I have never heard this mentioned in any setting ie investigator conversation or meeting.
Well I do not have any irregular astigmatism. I am wearing readers for near and far vision. 1.75 left eye, 2.0 for the right eye. Did any of the patients in your clinical trial experience color perception issues that did not resolve over time?
JFD: no. There is some concern with “ red vision “ or erythropsia but if present this was transient. An issue to be concerned about for sure but in practice was a non-issue. We see this with regular lenses especially if a case goes long. Always is a transient phenomenon.
Are they happy they had the LAL implant?
JFD: Universally yes.
Would you say that cataract surgery causes less dry eye symptoms than Lasik?
JFD: Yes. Anytime one undergoes surgery anywhere on the body and traumatizes a nerve which is anytime someone has surgery there can be symptoms. One of the these is neuralgia which can be experienced by patients after lasik or cataract surgery. Tends to be transient in nature as well.
Sorry for all the questions, but these are considerations I need to take into account. Most importantly, do the trial clinics use the latest "version" of the LAL lens.
JFD: The FDA trial is complete. No cases being done in the US. If a case is done outside the US it is the latest technology in all likelihood. Calhoun only wants the latest most advanced surgery to be performed.
In other words, as Calhoun Vision tweaks the lens for various reasons is that what gets dispensed to the surgeon for use?
JFD: Yes.
For example psbpsbpsb stated that the color red was very pronounced after adjustments and lock in procedures, also that the color green looks washed out. Is Calhoun working on lessening those affects and if so are those generation of lenses being sent to the Drs. in the approved countries and to the clinical physicians?
JFD: Not sure what psb is? PBS?? What you cite in first sentence is transient. Even within the study we modified the optics to minimize the erythropsia. I never had a complaint nor heard of a single patient from the other centers having a green desaturation. Not saying it didn’t happen in US or OUS but I have never heard this mentioned in any setting ie investigator conversation or meeting.
Can't get ask a question to work, but had a tecnis PCB00 implanted in my second eye. First eye had a blue light filtering lense. Initially felt sick as reason for the second surgery was implanting the wrong strength IOL. Seem to blending brightness but still concerned.Some glare but amazing colour vision. I've rarely worn sunglasses but have ordered reactolite lenses to hopefully improve this.Not sure on claims of safer driving conditions. Better at night but glare in full sunlight a problem. Hope that my insomnia will improve.
1 Comments
September 19th I am getting a measurement for my right eye. The 27th Dr Schnippner is removing the cataract and putting in a toric Tecnis Symfony lens. The doctor is located in Jacksonville Florida.
Great news. for all Americans.
When going to the infrmaiton available about het apporval one part of it drew my attention in the link below
"... and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult.
http://abbott.mediaroom.com/2016-07-15-FDA-Approves-the-Tecnis-Symfony-Intraocular-Lenses-the-First-and-Only-Extended-Depth-of-Focus-Lenses-for-People-with-Cataracts
\ also ntoed that simular language was used in documentation for other AMO multifocal IOLs.
What does rarely mean? Is it possible to quantify this? 1 in 10, 1 in 100, 1 in 1,000, 1 in 10,000 cases? And, does this also not apply for each retinal investigation (via SIT lamp, OCT)?
Regards, John
When going to the infrmaiton available about het apporval one part of it drew my attention in the link below
"... and rarely, may make some types of retinal treatment (e.g., retinal tear repair) more difficult.
http://abbott.mediaroom.com/2016-07-15-FDA-Approves-the-Tecnis-Symfony-Intraocular-Lenses-the-First-and-Only-Extended-Depth-of-Focus-Lenses-for-People-with-Cataracts
\ also ntoed that simular language was used in documentation for other AMO multifocal IOLs.
What does rarely mean? Is it possible to quantify this? 1 in 10, 1 in 100, 1 in 1,000, 1 in 10,000 cases? And, does this also not apply for each retinal investigation (via SIT lamp, OCT)?
Regards, John
10 Comments
The issue seems to be that seeing through the lens to see the retina isn't as easy with a non-monofocal. I would suspect that its easier with the Symfony than with a multifocal, but unfortunately I haven't seen any discussion of the issue. It may be that they mostly put that in as a disclaimer "just in case" there are problems, since they hadn't researched the issue.
On a page about multifocals the issue was raised about their potential to complicate retinal surgery. It was pointed out that some retina surgeons say it can make some cases more complicated, but there weren't statistics given. I didn't save links at the time when I checked on the issue out of curiosity, since I didn't find a good reference with statistics or more detail. A search at the time merely turned up references to some retinal surgeons saying in some uncommon complicated cases they might make things more difficult, but that they could alter their technique to deal with it and get the job done. Other retina surgeons were quoted as saying that those who have retinal issues might steer clear of multifocals since they preferred not to have anything complicate the process (but that doesn't mean they can't accomplish it anyway, even if its more difficult). Unfortunately nothing I saw gave statistics about the issue, and the fact that there wasn't much coverage of it suggests its likely a rare concern.
I would suspect that in the rare case where it might cause enough problems to worry about, they could first do a lens exchange (or remove the lens temporarily). Obviously that is added risk and inconvenience, but adding some risk to a rare occurrence needs to be traded off from the benefit of expecting better vision for most people.
On a page about multifocals the issue was raised about their potential to complicate retinal surgery. It was pointed out that some retina surgeons say it can make some cases more complicated, but there weren't statistics given. I didn't save links at the time when I checked on the issue out of curiosity, since I didn't find a good reference with statistics or more detail. A search at the time merely turned up references to some retinal surgeons saying in some uncommon complicated cases they might make things more difficult, but that they could alter their technique to deal with it and get the job done. Other retina surgeons were quoted as saying that those who have retinal issues might steer clear of multifocals since they preferred not to have anything complicate the process (but that doesn't mean they can't accomplish it anyway, even if its more difficult). Unfortunately nothing I saw gave statistics about the issue, and the fact that there wasn't much coverage of it suggests its likely a rare concern.
I would suspect that in the rare case where it might cause enough problems to worry about, they could first do a lens exchange (or remove the lens temporarily). Obviously that is added risk and inconvenience, but adding some risk to a rare occurrence needs to be traded off from the benefit of expecting better vision for most people.
What is the term used to describe this lens? It is extended depth of focus, or what is the best term to use for the Symfony? It is not a monofocal but not a multifocal, is that right?
The usual description is "extended depth of focus", which is a new category of lens. In Europe there are other examples like the IC-8 (which uses the pinhole effect, its done by the company that does the Kamra inlay which also uses the pinhole effect).
I will look into the question of retina issues and this IOL. Thx SD.
I had my first tecnis multifocal implanted about 8 weeks ago. Having terrible night vision. Glare/halos/starburst. Also have a gel like cloudy vision over the outermost part of the eye. My surgeon (who has never used Symphony) suggested we explant the multifocal for the Symfony. Should I be concerned he has never used this lens before?
The Symfony is implanted the same as other Tecnis lenses, it is the same size and shape overall if you are just looking at it. It has different optics , but that has no impact on the surgery itself (picture it like getting glasses with the same frame, but just a different lens inside them). So it shouldn't matter if the surgeon has used it before if they are used to Tecnis lenses.
I'm curious what the "gel like cloudy vision" might be, if you have some other eye health issue that is impacting your vision that would also cause trouble with another lens as well. Unfortunately even with a monfocal there are some people that get problematic halos and glare issues so there is no guarantee a lens exchange will improve things, but hopefuly it will so its something to consider. The risk is lower with the Symfony or a monofocal. I am curious what the odds are that someone who has halo problems with one lens will be more likely to have them with other lenses, but I'm not sure if there are studies on the issue since only a small fraction of patients get lens exchanges so most doctors won't have enough data by themselves, they'd need a high volume clinic to get enough data data or a multi-center study.
I'm curious what the "gel like cloudy vision" might be, if you have some other eye health issue that is impacting your vision that would also cause trouble with another lens as well. Unfortunately even with a monfocal there are some people that get problematic halos and glare issues so there is no guarantee a lens exchange will improve things, but hopefuly it will so its something to consider. The risk is lower with the Symfony or a monofocal. I am curious what the odds are that someone who has halo problems with one lens will be more likely to have them with other lenses, but I'm not sure if there are studies on the issue since only a small fraction of patients get lens exchanges so most doctors won't have enough data by themselves, they'd need a high volume clinic to get enough data data or a multi-center study.
I assume what I am seeing laterally is the edge of the IOL. It looks like there is a tear in my eye that I need to blink away. Always there but I notice it more when looking with close vision vs. distance. I will let you know if the Symfony helps the halo and starburst issues. Praying it works!!! The surgeon who performed my surgery did 50 cataract surgeries the day I had mine. Not sure if this a norm or not?
Also not sure what all of the measurements people talk about before surgery. I don't recall the Dr. taking measurements of my eye? He was very quick. Spent only a few minutes with me and had his tech discuss only option for lens were monofocal or tecnis multifocal lens.
"Mean binocular uncorrected visual acuity at intermediate (66 cm) was 20/20 (0.002 LogMAR) at 6 months, and mean binocular uncorrected visual acuity at near (40 cm) was between 20/25 and 20/32 (0.146 LogMAR), according to data presented by Dr. Jones."
Seems like the near vision in this study did better than the defocus curve currently published on Abbott's site. (around 20/40)
Great news. Hopefully the trial data will be published soon.
Seems like the near vision in this study did better than the defocus curve currently published on Abbott's site. (around 20/40)
Great news. Hopefully the trial data will be published soon.
2 Comments
Four toric models? Any information on what the differences between the four models might be? Great news though.
1 Comments
I have no idea how long it will the supply chain to be stocked with new IOLs. As for the toric think each just corrects a different amount of astigmatism i.e. 1 diopter 1.5 diopter 2 diopter 2.5 or 3 diopter
Nice that's great to hear, how long do you think that it'll take local clinics to start using the new Symfony's in the U.S? I assume many surgeons may sway away from it until they have some patient experience and feedback from using the Symfony before bringing it in as one of their main lenses.
1 Comments
My doc was totally ready to get on board. He was already very familiar with the studies and the promises when I happened into his life asking for Symfony. He called his Abbott rep while I was in his office. Magically, my lenses appeared in time for surgery. Once he knew he could obtain lenses, he began discussing it with appropriate patients. He had a 2nd Symfony patient within a couple of days. We were both done 2 days ago. I don't know my vision number but the other patient was tested today at 20/25 (she and I shared our experiences). Two days!!
Dr. Paul C. Lee in Los Angeles is the amazing doc. My Symfony lens was -12 and today I am using my smallest laptop!! My eyes aren't totally settled and I still see better than I have ever seen! Find an early adopter in your town. I focused on finding an experienced Abbott doc because the measurements and insertion are the same as other Abbott lenses. Translatable experience!! Why wait for the crowd?
Dr. Paul C. Lee in Los Angeles is the amazing doc. My Symfony lens was -12 and today I am using my smallest laptop!! My eyes aren't totally settled and I still see better than I have ever seen! Find an early adopter in your town. I focused on finding an experienced Abbott doc because the measurements and insertion are the same as other Abbott lenses. Translatable experience!! Why wait for the crowd?
Here is an article covering its approval:
http://eyewiretoday.com/2016/07/15/fda-approves-the-tecnis-symfony-iol-the-first-and-only-extended-depth-of-focus-lenses-for-people-with-cataracts
http://eyewiretoday.com/2016/07/15/fda-approves-the-tecnis-symfony-iol-the-first-and-only-extended-depth-of-focus-lenses-for-people-with-cataracts
2 Comments
So what benefits would you say a regular monofocal have over a Symfony now? A Symfony has less complications than a multifocal and is comparable to a monofocal and serves as an extended range IOL. A monofocal is covered by insurance and may have more crisp distance vision but I don't see any other benefits that a monofocal or Toric has over the Symfony models.
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