New FLEX procedure to correct myopia . 051010

[Mdm Tang]

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New FLEX procedure to correct myopia


Posted: 05 October 2010 1912 hrs


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New FLEX procedure to correct myopia









SINGAPORE : Correcting vision in a myopic eye used to mean going for LASIK treatment. Now there is an even more advanced alternative that promises to halve the treatment time and cause less discomfort.

Known as FLEX or Femtosecond Lenticule Extraction, this treatment uses just one laser to LASIK's two.

The special VisuMax laser used with FLEX cuts a lens-shaped layer from within the cornea and shapes it to correct vision.

The Singapore National Eye Centre, which has done about 30 such treatments this year, said this works even better with higher degrees of up to 1,000.

The procedure, which has also been tested in other parts of Asia and Europe, is available at around S$2,300 to S$2,500 per eye.

FLEX may even be reversible, which will help those who develop long-sightedness or presbyobia as they age.

Professor Donald Tan, director, Singapore National Eye Centre, said: "Because we are not using the excimer laser to burn away the myopia, but we are actually cutting a lens shape out, we feel we might be able to make use of that again.

"Our research at the Singapore Eye Research Institute is (that) now we have patented a technique where we can actually keep that lens piece, store it for the patient in case later on for whatever reason, maybe you develop "lau hua" (long sightedness) or anything else, we can implant that lens back ... and restore some of the myopia.

"But that still remains to be seen. That's still under research."

- CNA/al




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[Mdm Tang]

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Study finds new FLEX laser surgery promising for correction of myopia



September 9, 2008


A new single-laser refractive surgery called femtosecond lenticule extraction (FLE or FLEX) may be the next big thing in laser vision correction.

The new procedure uses a femtosecond laser — the type of laser used to create the flap in LASIK eye surgery — to create and remove a small disc of tissue from within the cornea to reshape the eye and correct vision.

Preliminary results from a recent German study show FLE provides safe and effective correction of myopia in a limited number of study eyes.


FLEX may be a less costly alternative to LASIK


LASIK is currently the most popular vision correction surgery worldwide. One limitation in making LASIK more affordable is that it requires the use of two expensive surgical instruments — one to create the corneal flap and one to reshape the cornea.

The instrument used to create the corneal flap can be a mechanical microkeratome or a femtosecond laser. The instrument used to reshape the eye to correct myopia, hyperopia and/or astigmatism is an excimer laser. The all-laser combination of a femtosecond laser for flap creation and an excimer laser for corneal reshaping is continuing to gain popularity. But this is also the most expensive combination, making the cost of LASIK too expensive for many people who want laser vision correction surgery.

Because only one laser (the femtosecond laser) is required to perform FLE, it's possible that the new lenticule extraction procedure may be less expensive than LASIK.

The FLEX procedure

Femtosecond lenticule extraction is essentially a 4-step procedure:

The femtosecond (FS) laser creates the back side of the lens-like disc of tissue (lenticule) at a specified depth within the cornea.
The laser then creates the front surface of the lenticule within the cornea.
A circular side cut is created with the FS laser to complete the creation of the lenticule and to create a LASIK-style corneal flap. A small area of uncut tissue in the side cut creates a hinge for the flap.
The surgeon manually lifts the flap, removes the lenticule with a forceps, and replaces the flap. As in LASIK, the flap reattaches to the corneal bed without the need for stitches.


Study design and methods

In this study, FLEX was performed on 10 eyes of 10 subjects who had myopia in the range of -2.00 to -8.00 diopters (D) and less than 1.00 D of astigmatism. The mean age of the subjects was 39 years (range 32 to 62 years).

The laser used to perform the surgery was the VisuMax femtosecond laser system (Carl Zeiss Meditec AG).

Like all femtosecond lasers, the VisuMax system "cuts" tissue by using high-energy pulses of light to vaporize cellular bonds at a specified depth within the cornea. During this process, tiny gas bubbles are formed by the vaporization of tissue, and these bubbles enable the surgeon to see the tissue separation taking place.

To minimize the risk for overcorrection, the target refractive endpoint for all eyes was set at -0.75 D of residual myopia.

After the procedure, the FLEX eyes were examined at 1 day, 1 week, and at 1, 3 and 6 months.

Study results

The data collected during the follow-up visits of the subjects yielded these findings:

90 percent of the eyes were within +/-1.00 D of the target refractive endpoint and 40 percent were within +/-0.50 D.
90 percent of the treated eyes attained uncorrected visual acuity (UCVA) of 20/40 or better.
The refraction stabilized by the 1-week follow-up visit, but there was a little regression until the final follow-up at 6 months.
Four eyes (40%) gained 1 line of best spectacle-corrected visual acuity (BSCVA) and 2 eyes (20%) gained 2 lines of BSCVA.
One eye (10%) lost 1 line of BSCVA. No eyes lost 2 or more lines of BSCVA.
No eyes had a significant increase in higher order aberrations (HOA) after surgery.

Two eyes (20%) exhibited optically insignificant microscopic folds (microstriae) in the periphery of the corneal flap. No other lasting side effects were found.
On a standardized questionnaire, all patients said they were very satisfied with the results and wished to have their fellow eye treated with the FLEX procedure.


Conclusions
When evaluating the outcomes of the FLEX procedure in this study, the researchers commented that the surgery "exceeded our expectations" and that FLE appears to be "a gentle and safe procedure." But while results of this small study are encouraging, they caution that larger studies with longer follow-up periods are required to further evaluate FLEX as a possible alternative to LASIK.

Editor's Note: At this time, FLEX remains an investigational procedure and is not yet approved by the U.S. FDA for use in the United States. To get the latest news about LASIK, PRK and emerging refractive surgery procedures like FLEX, subscribe to our RSS news feed. Just click on the "RSS News Feed" icon at the top or bottom of this page.

SOURCE: "First efficacy and safety study of femtosecond lenticule extraction for the correction of myopia." Journal of Cataract and Refractive Surgery. Vol 34, No 9. September, 2008.

Last updated: February 2010



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[Mdm Tang]

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Femtosecond Lenticule Extraction for the Correction of Hyperopia

Femtosecond procedures for hyperopia are on the horizon.


By Walter Sekundo, MD



Hyperopia is difficult to treat with excimer lasers. When dealing with this refractive error, we must find a strategy that replaces the excimer laser with an entirely different approach. Some surgeons, including myself, feel the femtosecond laser might be an appropriate platform. Considering the excellent results with myopic femtosecond lenticule extraction, or FLEx, we need to consider the possibility of all-femto hyperopic treatments. This will not happen next week or next month; however, in the years to come, I am convinced that hyperopia treatments with the femtosecond laser will enter the market.

This article releases initial 1- and 6-month data of an ongoing trial for FLEx hyperopia correction with the VisuMax femtosecond laser (Carl Zeiss Meditec, Jena, Germany). Data is currently available for 25 eyes. Patients required between 2.00 and 4.00 D of correction. The average age was 42 years. All surgeries were performed either by Marcus Blum, MD, of Erfurt, Germany, or by Walter Sekundo, MD, of Marburg, Germany. A 7-mm optical zone was used for all treatments. This study will continue to its 9-month endpoint.

When using a combined treatment such as femto-LASIK, the flap must be larger to allow the excimer laser ablation. In FLEx, we work with small flapsÑin fact, usually just 0.5 mm in diameter larger then the refractive lenticule. The main point to consider is that the lenticule must not contain any sharp edges; the refractive treatment effect will otherwise result in regression. Therefore, the main challenge is to find an optimal form of the lenticule edge.

RESULTS

Safety. At the 6-month follow-up, a small percentage of eyes (12%) gained 1 line of BCVA, and the majority (56%) remained unchanged (Figure 1). As not unusual with hyperopia treatments, some patients (28%) lost 1 line of BCVA.

Predictability. In terms of UCVA, 32% were 20/20 (1.0) or better, 60% were 20/25 (0.8) or better, and all eyes were better than 20/40 (0.5). These results are acceptable for the very first feasibility study in hyperopic eyes. No serious adverse events or complications happened in this group of patients. However, three patients experienced a mild transient haze-like reaction in the interface seen at the slit lamp, and three cases of microstriae were reported.

Stability. Unlike in FLEx-treated myopic eyes with their superb stability, unchanging refraction, and no signs of regression, the initial experience with hyperopic FLEx showed some amount of regression just as with excimer lasers (Figure 2). Whereas the data we have at 1 month was great, the 6-month results look somewhat worse. We therefore extended the study past 6 months because we know that hyperopic eyes tend to experience regression after this time. We will evaluate the 9-month data and report our results in the near future.

The stability and excellent results of myopic FLEx have been proven in several investigations, which include results from nearly 1,000 eyes. Our initial results for hyperopic treatments suggest that FLEx also works for the correction of hyperopia. Results may not be as good as in myopic eyes; however, the same is true for excimer laser treatment in hyperopia versus myopia.

We have come a long way to design an all-in-one option for hyperopic treatment, but we are still at the beginning of clinical development. I believe we have more work to further define the parameters for this treatment and create a better resection (ie, ablation in excimer laser terminology) pattern. However, our initial results safely conclude that FLEx has the potential to become an option for hyperopic treatments.

Walter Sekundo, MD, is Professor and Chairman of the Department of Ophthalmology, Philipps University of Marburg, Germany. Professor Sekundo states that his research has been supported by Carl Zeiss Meditec. He may be reached at e-mail: [email protected].



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[Mdm Tang]

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http://www.youtube.com/watch?v=ewWP1Z6HD8Y

http://www.optometry.com/blog/lasik/femtosecond-lenticule-extraction-flex-a-new-paradigm-for-lasik/

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Shows a new way of using a femtosecond laser for refractive surgery. This is all-femtosecond lasik procedure, called FLEx or Femtosecond Lenticule Extraction. Unlike traditional femtosecond lasik, as with an intralase, where a femtosecond laser is used to make a flap, and the lenticule is ablated with an excimer laser, this procedure involves creating a lenticule and flap with the femtosecond laser, and then physically extracting the lenticule. It promises a safer, more accurate and cheaper …

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[Ramseth]

You're so interested in this. Your eyes how many degrees?

 

[Mdm Tang]

You're so interested in this. Your eyes how many degrees?

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my client's clinic lah ...


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[Ramseth]

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my client's clinic lah ...


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Sorry can't be your client's client. My eyesight 6/6 20/20.