OPTIMAX Technology

Posted on April 1st, 2009 by admin

 
OPTIMAX is proud to announce that we are the only centre with the most vision correction platforms in Malaysia. Apart from the vast range of treatment procedures available, OPTIMAX also own the most laser machines that allow the treating doctor to have the variety and choice to decide the best laser vision correction for individual patient. By understanding the limitations of tools and techniques, as well with the know how to make use of the right tool, we are committed to deliver the best outcome.
 

Laser machines available in OPTIMAX:

  • Alcon LADARVision 4000 Laser
  • NIDEK EC-5000 Laser
  • Bausch & Lomb Technolas ® 217 Zyoptix 100 Laser
  • Carl Zeiss MEL 80TM Laser
  • IntraLase® FS Laser (Intralasik)
  • Wavelight Allegretto Wave Eye-Q Laser
     
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Is LASER MACHINE (TOOL) the main factor to consider for surgery?

No doubt every centre will claim to be the best or use the latest technology. So do OPTIMAX. We are delivering the promise by having the most technology. That is why you should choose OPTIMAX, because of the numerous laser machines (tools) available.
 
And more importantly, OPTIMAX‘s laser machines are well maintained with OPTIMAX's in-house laser engineers; the only centre in Malaysia with such a dedicated team. This is very important to have the own engineers to maintain the machines, as to make sure the machines always kept to the tip-top performance to treat on every case.


U.S Food and Drugs Administration (FDA)
All machines used in OPTIMAX are approved from the FDA in term of the safety and effectiveness.
The clinical data from FDA is evidence-based, accountable, efficient and transparent. OPTIMAX machines include:

Device Name Company Date Approved Reference
MEL 80 CARL ZEISS INC
Feb 14, 2008

Aug 11,2006

P060004S002

P060004

WAVELIGHT ALLEGRETTO

WAVE EYE-Q

ALCON LABORATORIES

INC.

Apr 09, 2007

June 16,2006

P020050S005

P020050S003

LADARVISION 4000 ALCON LABORATORIES

INC.

Sep 12, 2004 P970043S015
BAUSCH& LOMB

TECHNOLAS 217Z ZYOPTIX

BAUSCH & LOMB SURGICAL INC Oct 10, 2003 P990027S06
NIDEK EC-5000 NIDEK INC Nov 08, 2006

Sept 29,1999

P970053S010

P970053S1


Submission of data to the FDA is done to obtain their acknowledgement that the lasers meet safety and effectiveness criteria, and safe to use on human eyes. It should however be highlighted that the FDA does not specify the design requirements that must be followed. Hence, data that is collected from various designs, with differing patient recruitment criteria, will undoubtedly produce different results.
It is therefore important to take precautions when interpreting FDA data. Results can be manipulated and patients selected to ensure the most attractive data. Most experts agree that surgeon skill and experience and the quality of care before and after LASIK are far more critical factors affecting the final vision outcome.
 

A number of important points can help keep the FDA data in perspective:


Today's results are probably better than FDA data
 

By definition, FDA trials occur during the early period of a laser's life cycle. Manufacturers are allowed to and often do make technical improvements to the instruments during the trials. With increasing surgeon experience over time, the results in actual clinical practice are often better than the initial FDA data.
 

FDA data in one study cannot fairly be compared to FDA data in another study
 

Manufacturers go to the FDA with various study designs, which often have differing endpoints and patient-enrollment criteria. Although all studies must answer certain basic questions regarding safety and effectiveness, they are not designed to be compared with one another.
 

Studies don't cover every possibility

Just because you have a characteristic or condition that is not covered by the approved labeling of a laser doesn't mean that the laser won't work for people with your characteristic or condition. Once the FDA approves a laser, your surgeon can use it any way he or she deems appropriate. In medicine, doctors often use one technology for a patient with a condition that was not in the FDA clinical trial. It's called a physician's practice-of-medicine prerogative. The use of that equipment in this regard is called "off-label," while characteristics included in the FDA study are "on-label."

 

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