FDA Approves Staar Surgical Toric Visian ICL

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Now you can have clear Vision without glasses or contacts! The Visian Toric ICL can correct Nearsightedness and Astigmatism.

  • Are nearsighted with  astigmatism from -3.0 D to ≤ -15.0 D (spherical equivalent) with astigmatism of 1.0 D to 4.0 D (Eyeglass measurements)
  • Are nearsighted with  astigmatism with spherical equivalent ranging from greater than -15.0 D to -20.0 D (spherical equivalent) with astigmatism of 1.0 D to 4.0 D (Eyeglass measurements)
  • Have an anterior chamber depth (ACD) of 3.00 mm or greater, from the  back of the cornea to the front  surface of the natural lens
  • You must have a stable refractive history (within 0.5 D for both spherical equivalent and cylinder for 1 year prior to implantation).
  • The Visian TICL is  for placement in behind the Iris  of an eye with is natural lens intact.
Visian Toric ICL

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MONROVIA, Calif.–(BUSINESS WIRE)–Sep. 13, 2018– STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that the FDA has granted approval of the PMA Supplement for the Visian Toric ICL for the correction of myopia with astigmatism.

This approval represents a meaningful expansion of the Implantable Collamer® Lens (ICL) product line for the correction of refractive error in patients with both myopia and astigmatism which are common conditions in the United States (US). Astigmatism affects approximately 30 percent of the population.1

The ICL in both spherical and toric designs has been associated with significant improvements in quality of life. Patients have described ICL surgery as “life changing” or wished they had opted for the surgery sooner.2 The approval of the Visian Toric ICL is also an important step towards the future availability of advanced ICL models in the US, such as the EVO/EVO+ Toric ICL.

“FDA’s approval of STAAR’s Visian Toric ICL in the U.S. provides an exciting treatment option for myopic patients with astigmatism in search of visual freedom. We are thrilled to be able to offer this lens in the United States and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients on November 1st, 2018,” said

FDA approves update to IOL master 700 to include posterior corneal measurements

Dr Titone at East Carolina Center for Sight has been selected to be one of the first in the USA to receive the new Total Keratometry upgrade for the IOLMaster 700. This will allow us to select the best possible Lens power for our cataract surgery patients.

The IOLMaster®700 from ZEISS with SWEPT Source OCT technology now allows us to directly measure the posterior corneal surface. It combines unique telecentric keratometry measurement of the anterior corneal surface with measurement of the posterior corneal surface in order to calculate Total Keratometry (TK®).

  • There are two exclusive new formulas: Barrett TK Universal II and Barrett TK Toric
The current Barrett Toric Calculator uses a unique eye model to predict the posterior corneal surface. Using Total Keratometry with the Barrett Toric Calculator would thus lead to overcompensation of posterior corneal astigmatism.
Because of this, Graham Barrett has developed two new IOL power calculation formulas: the Barrett TK Universal II for non-toric IOLs, and the Barrett TK Toric for toric IOLs. Both new formulas use posterior corneal surface measurements instead of the eye model used by the Barrett Toric Calculator
  • We Can use existing IOL calculation formulas – no need for a second device, third-party software or an online calculator
This decreases errors in manual data entry and streamlines workflow.
 

East Carolina Center for Sight where Great vision is Our Mission.

 

Search for the Right Lens power for Cataract surgery

IOL Master 700

As the patient demand for eyeglass free vision has increased manufacturers have responded with a diversity of lenses to implant. There are now lenses to correct astigmatism, reading vision, intermediate vision and even light adjustable lenses.

This has increased the burden on eye surgeons to calculate the exact power of a lens to implant. There are various machines to acquire measurements and several formulas to use this adds a lot of time and work to getting that perfect lens for our patients.

Dr Titone has acquired then IOL master 700 to achieve the best results possible for our patients.

With the Carl Zeiss IOL master 700 We have the most advanced biometry system for IOL power calculation with the latest integrated lens calculation formulas.  This allows all the needed measurements to be completed rapidly and reproducibly. With innovations like telecentric keratometry to allow accurate keratometry readings even if the focus is difficult for the technician. Swept source OCT to measure the length of the eye, the lens, corneal thickness and the AC depth with repeatable accuracy. A scan of the macula is also done allowing us to detect subtle abnormalities needing further investigation that may have been missed with older technologies and standard exams. All the measurments can be accomplished within 1 minute or less for both eyes!

Zeiss has plans to add to this platform with additional advances to the calculation formulas; and with the recent acquisition of the Veracity surgical suite, Cataract and IOL tracking.  This will become the new gold standard for Catarct surgery.  The IOL master 700 also takes images of the eye for use with Zeiss’s Calisto intraoperative real time heads up digital display for their Lumera microscope that can help eye surgeons get the best alignment possible for toric IOLs to correct astigmatism. We hope to add this tool soon.

With tools like these it’s a great time to be a refractive cataract surgeon.  More patients then ever before can be eyeglass free after cataract surgery.

Refractive Laser Assisted Cataract Surgery Coming to East Carolina Center for Sight

Refractive Laser Assited Catarct Surgery arrives!
Refractive Laser Assited Catarct Surgery arrives!

I am excited to announce the arrival of Refractive Laser assisted cataract surgery (ReLacs) at East Carolina Center For Sight.

ReLacs is a package of services including:

The LenSx Laser from Alcon: A Femtosecond laser to make all incisions in the eye including the lens to achieve the most accurate and reproducible currently available surgery. Use of the laser results in a safer procedure. Less ultrasound is necessary to remove the lens particles as well.

Multiple additional eye measurements using different methods  and multiple different methods of calculation to allow me  to get the most accurate determination of your intraocular lens power. This is in addition to the standard measurements done in regular cataract surgery.

The ReLacs package can be paired with a Lifestyle lens; Multifocal or Toric to allow the best correction and rehabilitation of your vision.

Animation LenSx

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Live surgery with LenSx  , Ultrasound is used in second half of surgery to remove lens fragments but the amount of energy is much less than conventional surgery.

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The most recent software updates have made the laser faster, the imaging sharper, and the interface better improving the procedure even more.

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See if you are a candidate for ReLacs with the LenSx Laser! Schedule your evaluation Today.

 

What’s New in Ophthalmology

Alcon announced the immediate availability of  their expanded range of  Acysof  T6 through T9   Astigmatism correcting Intra ocular lens  implants.  This means we can now correct a broad range of  Astigmatism with the lens we put in the eye at the time of cataract surgery allowing more patients to be eyeglass free after surgery!  We have been using the lower power Acrysof  Toric lenses T3-T5 with great success.  Patients with higher astigmatism needed additional surgery to fully correct vision, now most patients  can be done with the lens alone.  Patients with even higher astigmatism that could not be fully corrected at all can now be corrected with additional surgery. These new lenses correct from 2.57  to 4.11 diopters of astigmatism. You can learn more about this lens here  http://www.reclaimyourvision.com/acrysof-iq-toric-iols.aspx.

Screen shot 2011-05-28 at 12.59.16 PMtetraflextoric

If you are wanting better reading vision theAlcon Acrysof Restor lens has to be a great choice for your Cataract or Clear lens replacement surgery; soon the astigmatism correcting feature of the Acrysof  toric Intraocular lenses will be combined with this lens for patients with astigmatism!  Alcon just announced these lenses outside the USA, after FDA approval they will be available here. Learn more here http://www.restortoric.com/.

On the Focusing lens front (We call these Accommodating Intraocular lenses): Lenstec’s Tetraflex is an intraocular lens implant (IOL) that is used for cataract surgery.   The Tetraflex IOL accomodates to give a range of vision.  The Tetraflex is not yet FDA approved in the United States, but is currently in use in Europe.  Lenstec will also introduce Tetraflex HD after FDA approval.  Lenstec’s Softec HD is a precision monofocal lens that is already FDA approved for single focus lens replacement.  The expected advantage of the Tetraflex and Tetraflex HD over the Softec HD is a wider range of sharp vision without glasses or contact lenses for distance, computer, and reading activities.  The lens works by flexing within the eye when patients attempt to read. Dr Titone uses the SoftecHD lens by Lenstec its clarity of vision reported by patients is impressive, we are looking forward in offering the TetraflexHD to our patients when it becomes FDA approved.

Tetraflex reviews have been favorable by surgeons and patients.  Tetraflex lens in the news  Click this link to an article by a U.S. surgeon who has implanted Tetraflex as part of the FDA trials.

See the TV news story about patient who had Tetraflex IOL in Miami during U.S. FDA trials.

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The Acysof Toric, Acrysof Restor and Tetraflex costs are usually partially covered under medical insurance, there are added out-of-pocket costs compared to standard lenses. If you are seeking the best vision you can have after cataract or clear lens surgery you should consider one of the Advanced Technology lenses, speak to Dr Titone about your options or ask questions on the blog.