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I - 2010   Technolas Perfect Vision on-line newsletter  
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Summary
Review of Technolas Perfect Vision’s first year
TECHNOLAS Femtosecond Workstation 520F special focus
Editor's note
In this issue we have a special focus on the TECHNOLAS® Femtosecond Workstation 520F. In what has been a productive and successful first year for the newly formed Technolas Perfect Vision GmbH, the latest technology enhancements and developments to the laser system will be reviewed along with new INTRACOR® data from Dr Gutiérrez, Spain.

Editorial team
 
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Review of Technolas Perfect Vision’s first year

Technolas Perfect Vision has completed its first full year of operation, following the joint venture between Bausch & Lomb’s refractive business and 20/10 Perfect Vision, the femtosecond laser developer. Truly focusing upon the laser vision correction industry, TPV has the full range of expertise in both the femtosecond and excimer refractive businesses.

The integration of the 2 companies has now been successfully completed. During 2009, TPV has already made great progress in building its brand, growing the business, and optimizing the R&D pipeline to bring the most advanced technologies to the refractive market.

A new manufacturing facility has been established at the TPV headquarters in Munich, Germany, to increase the manufacturing capacity of the TECHNOLAS Femtosecond Workstation 520F. In the excimer business, TPV launched the latest algorithm, the ZYOPTIX® Personalised Treatment Advanced (PTA), which is already providing further improved outcomes and reducing retreatment rates. The latest and innovative excimer technology, the TECHNOLAS Excimer Workstation 217P has also been introduced to provide surgeons with enhanced ease of use, improved performance and the most complete range of premium procedures allowing surgeons to increase the profitability of their practice.

The company is looking forward to an exciting 2010 with the forthcoming availability of the new PresbyLasik algorithm and expanded INTRACOR® indications.



 
TECHNOLAS Femtosecond Workstation 520F special focus

The TECHNOLAS Femtosecond Workstation 520F (TECHNOLAS 520F) is now commercially available across Europe and Asia, with the system now installed in over 13 countries across these regions. A highly versatile system, the TECHNOLAS 520F provides innovative procedures to treat presbyopic patients, create flaps and can be used for a broad range of therapeutic applications. These procedures are personalised through the software modules INTRACOR, CUSTOMFLAP® and CUSTOMSHAPE™.

Latest 520F innovations

  >   A new laser head - A new laser head is now installed in the system to improve accuracy of outcomes, providing excellent stromal bed quality.
  >   Faster flap procedures - The laser now operates at 80kHz to allow flaps to be produced in only about 20 seconds.
  >   New centration software - Allows surgeons to recentre the procedure under the curved inter face via the software.
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Advantages for treating presbyopia

The TECHNOLAS 520F is optimised to treat presbyopic patients by the INTRACOR procedure thanks to the unique patented curved interface which:

  ·   Keeps corneal deformation to a minimum
  ·   Provides less stress with less suction
  ·   Allows different working depths throughout the treatment
  ·   Also allows CUSTOMFLAP and CUSTOMSHAPE

Frequently asked questions

To-date, over 2000 INTRACOR procedures have been per formed with up to 2 years follow-up data. The procedure is now gaining a great deal of interest among the refractive community. Some of the most frequently asked questions are answered below:

  >   How does INTRACOR work?
The procedure works by creating a series of concentric rings in the stroma in the central area of the cornea with the femtosecond laser. These rings result in a localised change in the biomechanical properties of the stroma, leading to a slight steepening of the central cornea.

  >   What are the patient indications?
They are the same as LASIK.

  >   What is the treatment range?
Currently the treatment range is presbyopic emmetropes and low hyperopes. Evaluations are underway to expand the INTRACOR indications for the correction of myopia, hyperopic, astigmatism and combined treatments.

  >   Is the treatment monocular or binocular? Is it monovision?
The procedure is both monocular, treating the non-dominant eye, or the patient can be treated bilaterally. For monocular procedure patient will have stereopsis for distance but kind of monovision for near because only one eye is treated. For binocular procedure, patient will get stereo vision for distance and near with even higher patient satisfaction.

  >   Is there a loss of distance visual acuity?
In some cases between 1 and 2 lines are initially lost, but these typically recover with time. Patient satisfaction is high and e.g. Dr Gutiérrez, Spain, said that 98% of his 42 patients would opt to have the procedure again.

  >   Is the INTRACOR procedure stable?
The procedure is stable because the overall structural corneal stability is not affected. Descemet and Bowman are also untouched.

  >   Are there regressions?
To date, no regression has been observed in either the CE study (12 months data) or outside the CE study (up to 24 months follow-up).

  >   What is the long term effect?
Until now, 2 year follow-up data is available and shows stable results.

  >   Is there any effect on IOP after the INTRACOR procedure?
None of the patients have a marked elevation of post-op IOP.

  >   Can INTRACOR be done in post-op LASIK treated patients?
Some experience on post-op LASIK eyes is available. The CE approved parameters are defined for virgin eyes, so using the CE approved patterns, some overcorrection may occur owing to the previous biomechanical alteration from the LASIK procedure.

  >   Can the INTRACOR procedure be performed in patients with early cataracts or should we wait until after the cataract procedure has been done?
Dr Luis Ruiz, from Colombia, has treated some cases, first by treating the cataract, then waiting for stable refraction before correcting the presbyopia with INTRACOR. Dr Gutiérrez prefers to per form the INTRACOR first, then the cataract, as in his experience, the results are better.

First INTRACOR experiences from Spain

Dr Carlos Gutiérrez Amorós, from Centro Oftalmológico Gutiérrez Mazeres y Amorós in La Coruña, Spain, has been using the TECHNOLAS Femtosecond Workstation 520F since November 2008. He has per formed a clinical study in parallel to the CE study with the same purpose to evaluate safety and efficacy of the INTRACOR procedure. To date, Dr Gutiérrez has per formed 75 INTRACOR procedures, evaluating three different patient groups: Group 1 - virgin eyes within the CE indications, Group 2 - phakic patients, and Group 3 - per forming INTRACOR prior to phaco.

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The results from Group 1 on 29 patients with a spherical equivalent pre-op between -0.50D and +0.75D are presented. After 3 months follow-up, 94.7% of the patients have a spherical equivalent within ≤ ± 0.50D, demonstrating the accuracy of the procedure. Patients experienced an impressive improvement in their near vision, gaining 4 or more lines in the 84.2% of cases, the equivalent of between J3 and J1 and better, whilst also maintaining a good distance visual acuity between 0.7 and 1.2.

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When comparing the changes in near uncorrected vision, 96.1% of the patients were only able to read between J5 and J10 before the surgery, whilst after one month post-op, 84% of patients are J3 or better, with 72% at J2 or better. This is a significant improvement of the quality of life of these patients.

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Dr Gutiérrez’s conclusions are:

  >   High improvement of UCNVA with a good intermediate visual acuity.

  >   Only slight decrease in UCDVA which is not affecting the patients’ quality of life and allows them to continue with their previous activities.

  >   84.2 % achieving 20/25 and J3.

  >   No effect on corneal hysteresis.

  >   Slight decrease of CRF.

  >   Slight corneal asphericity modification: anterior = posterior.

  >   Slight change in total aberrations and HOAs.

  >   No change in photopic and mesopic contrast sensitivity, pachymetry, endothelial cell number.

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