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Abbott Synchrony withdraws from US approval
I was hoping for 2014 approval after reading EU reports suggesting better results in intermediate vision,than the US approved Restor lense. I was diagnosed with cataracts in both eyes in Dec.2013,with vision being 20/40,20/50.Never have had glasses other than 1.75 readers. I know I will need the surgeries in 2014 and can't pick a lense. Any thoughts from the experts!
MEDICAL PROFESSIONAL
This is a very difficult question. Without a good accommodating IOL (intraocular lens) - I have been underwhelmed by the crystalens - the choices currently are monofocal implants for distance and then wear reading glasses; monofocal implants for reading and then wear distance glasses; monovision, with one monofocal implant for distance and one for reading; and the multifocal implant. Each option has advantages and disadvantages. Discuss these carefully with your surgeon, and don't be afraid to seek a second opinion.
Doctor:Here was his email to me. He had a pair of Crystalens installed! "If I had the opportunity to do it all over again, I would choose a fixed lens. Decide if you want to see clearly at a distance and then wear glasses for reading. If reading or seeing close up is important, then you will have to wear glasses for most thing like reading road signs and driving. As it is now, at least for me, I have to wear glasses for most everything that I do. Not exactly what I had planned and my vision is worse now than it was before the surgery. Please feel to call me if I can give you anymore information"
Dr Doreen,
While there are no perfect IOLs, all IOLs are not created equal. For instance, if you were going to have cataract surgery, which would be the last lens you would consider for your own eyes?
While there are no perfect IOLs, all IOLs are not created equal. For instance, if you were going to have cataract surgery, which would be the last lens you would consider for your own eyes?
MEDICAL PROFESSIONAL
There is no perfect IOL, either in the US or in other countries. Each has its own specific advantages and disadvantages. Since you drive at night for work, I would recommend the monofocal IOL for distance. The multifocal implants carry a risk of glare and halos at night. Most people do adapt to these over time, as the brain neuro-adapts to the new vision. However, a few people cannot adapt and require an IOL exchange, which is another intraocular surgery with its attendant risks. I would ask the hospital administrator you mentioned if he had multifocal implants; I don't think cataract surgery was the worst decision he ever made, perhaps it was the IOL.
Doreen: Have you been overwhelmed by any of the currently available IOC's available? This could aid me in discussions with my surgeon. You doctors are very busy people.
Monofocals in place with glee. Shave and computer work without glasses. Drive day (with standard sunglasses) and night with pinpoint accuracy with progressive glasses which also protect my investment in my eyes against projectile damage and other accidents. Corneal astigmatism handled with progressives. Brain is quite happy with my choice. Regards, Joe
Doctor,thanks for the quick comeback. After doing some reading I have been underwhelmed by the offerings available in at least in the "premium IOL's ". I have visited a Ophthalmologist with great credentials. His suggestion was to use the lens that you mentioned. I told him that I drive at night for work occasionally,have a passion for shooting sporting clays,and am a avid boater. I even went as far as to schedule the surgery but canceled a month away after a fellow shooter told me it was the worst decision he ever made. He was a hospital administrator by profession.
My issue moving forward is that this surgery is for the rest of your life and there does not appear to be a clear cut winner in the quest for the perfect IOL Unfortunately,medical information on the subject is fairly sparse also. I do appreciate this website for the fact that MD's take the time to chime in!
My issue moving forward is that this surgery is for the rest of your life and there does not appear to be a clear cut winner in the quest for the perfect IOL Unfortunately,medical information on the subject is fairly sparse also. I do appreciate this website for the fact that MD's take the time to chime in!
The worst part of it is thinking that the best solution could very well be outside US borders! In a quandary as to which way to proceed.
Thank you for the article.
Time to contact our congress-critters, even though they may be more broken than the FDA process.
Sad situation.
Time to contact our congress-critters, even though they may be more broken than the FDA process.
Sad situation.
Abbott ends development Of Synchrony IOL
Lens stalled in FDA approval process.
By David Chang, MD, with Jerry Helzner, Senior Editor
When Abbott Labs (Abbott Park, Ill.) paid $400 million to acquire IOL developer Visiogen for its Abbott Medical Optics (AMO) division in the late summer of 2009, American ophthalmologists were eagerly hoping for approval of a next-generation accommodating IOL. After all, Visiogen's Synchrony dual-optic accommodative IOL, had just completed its US clinical trials and had also received the CE mark in Europe earlier that year. The Synchrony looked to be a strong addition to enhance AMO's future positioning in the emerging premium IOL marketplace.
Now, more than four years later, American patients will not have access to this technology for the foreseeable future as the FDA did not approve Synchrony as an accommodating IOL. Reaction to the Visiogen acquisition was almost unanimously positive when it was first announced. At the time, the Synchrony was considered a “next-generation” accommodating IOL. Visiogen had designed the Synchrony “to mimic the eye's natural capacity to change focus, with the potential to deliver a full range of vision.” Synchrony had already been implanted in more than 1,200 eyes worldwide, with excellent clinical results.
Unfortunately, the Synchrony got stalled in the FDA approval process for three years and recently Abbott decided to do a scheduled sunset of the Synchrony Vu platform in Europe, which is a different model that was evaluated in the FDA clinical trial. The company issued the following brief statement in response to a question from this publication:
“Abbott has discontinued the Synchrony vu IOL and is focusing resources on next-generation technologies. Abbott remains committed to developing and providing the best options in accommodative, multifocal and extended depth of focus lenses.”
I served as medical monitor for the Synchrony's US trials. When asked why I thought the Synchrony never got through the FDA approval process, I said that without the benefit of an FDA panel presentation, it is hard to fully understand what the specific objections were.
One of the main problems is that the burden of proving true accommodation has become very difficult. Because there were no universally accepted standards for proving accommodation with an IOL, this made it very difficult for manufacturers to design their studies and diagnostic testing, and the criteria have certainly changed since the Crystalens (Bausch + Lomb) was approved in 2004.
With the Synchrony now out of the picture, other accommodating IOLs, such as the Fluid Vision (Power Vision, Santa Barbara, Calif.) appear to be years away from approval. Another promising IOL, the Calhoun Light-Adjustable Lens (Calhoun Vision, Pasadena, Calif.) is in phase 3 of its FDA clinical trial.
Lens stalled in FDA approval process.
By David Chang, MD, with Jerry Helzner, Senior Editor
When Abbott Labs (Abbott Park, Ill.) paid $400 million to acquire IOL developer Visiogen for its Abbott Medical Optics (AMO) division in the late summer of 2009, American ophthalmologists were eagerly hoping for approval of a next-generation accommodating IOL. After all, Visiogen's Synchrony dual-optic accommodative IOL, had just completed its US clinical trials and had also received the CE mark in Europe earlier that year. The Synchrony looked to be a strong addition to enhance AMO's future positioning in the emerging premium IOL marketplace.
Now, more than four years later, American patients will not have access to this technology for the foreseeable future as the FDA did not approve Synchrony as an accommodating IOL. Reaction to the Visiogen acquisition was almost unanimously positive when it was first announced. At the time, the Synchrony was considered a “next-generation” accommodating IOL. Visiogen had designed the Synchrony “to mimic the eye's natural capacity to change focus, with the potential to deliver a full range of vision.” Synchrony had already been implanted in more than 1,200 eyes worldwide, with excellent clinical results.
Unfortunately, the Synchrony got stalled in the FDA approval process for three years and recently Abbott decided to do a scheduled sunset of the Synchrony Vu platform in Europe, which is a different model that was evaluated in the FDA clinical trial. The company issued the following brief statement in response to a question from this publication:
“Abbott has discontinued the Synchrony vu IOL and is focusing resources on next-generation technologies. Abbott remains committed to developing and providing the best options in accommodative, multifocal and extended depth of focus lenses.”
I served as medical monitor for the Synchrony's US trials. When asked why I thought the Synchrony never got through the FDA approval process, I said that without the benefit of an FDA panel presentation, it is hard to fully understand what the specific objections were.
One of the main problems is that the burden of proving true accommodation has become very difficult. Because there were no universally accepted standards for proving accommodation with an IOL, this made it very difficult for manufacturers to design their studies and diagnostic testing, and the criteria have certainly changed since the Crystalens (Bausch + Lomb) was approved in 2004.
With the Synchrony now out of the picture, other accommodating IOLs, such as the Fluid Vision (Power Vision, Santa Barbara, Calif.) appear to be years away from approval. Another promising IOL, the Calhoun Light-Adjustable Lens (Calhoun Vision, Pasadena, Calif.) is in phase 3 of its FDA clinical trial.
Since the Synchrony IOL is a product from Visiogen Inc, and Abbott Medical makes the Tecnis IOL, I have to wonder about the source of your withdrawal information.
The Synchrony and the Tecnis Toric multifocal both still seem to be in the FDA pipeline (slow as it might be).
The Synchrony and the Tecnis Toric multifocal both still seem to be in the FDA pipeline (slow as it might be).
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