Intralase, or "Bladeless" as it is touted on television and radio advertisements has raised a lot of interest lately, as well as a lot of scientific studies to determine the true safety and efficacy of the devise. Intralase technology involves using a femtosecond laser to create the corneal flap before the LASIK procedure is performed. One point to note is that the technology is used only for creation of the flap, which although is important, is not the most important element of the LASIK procedure as it is often touted as being. It has essentially nothing to do with the laser actually used to make the vision correction or any of the surgeon's calculations.

Many ophthalmologists have spent considerable time researching Intralase, and most have concluded that at this time the technology may be helpful to some practices that are "very inexperienced" and have difficulty during the flap creation part of the Lasik procedure. At the present time, however, this technology has many significant and obvious drawbacks along with troublesome complications and results that although rarely occur, could negatively impact the patient's outcome and overall Lasik experience.

The high cost of the laser is passed along to the patient with increased fees and no obvious benefit to the patient. Nevertheless, the surgeons who use Intralase try to use the approach that this part of the LASIK procedure uses a laser rather than a microkeratome to make the flap in order to play on the public's fears, and the perception that since a laser is used to make the flap, it must be better. This is only a marketing ploy and certainly is not true as outlined below.

Furthermore, it sets a dangerous and unethical precedent of trying to deceive the public by using fear, hype and exaggeration as marketing tools in order to increase patient volume. Intralase was invented only to raise a corneal flap, and can be helpful for less experienced surgeons, and those who readily experience a number of flap complications, which are rare and extremely unusual in experienced hands using the widely used microkeratome. Intralase has its own unique set of complications and drawbacks that should make the patient take a second look at the relative safety and efficacy of the technology. None of these complications exist with the microkeratome.

Here are some examples that highlight those complications.

Note: This data was compiled from the nationally publicized: "Controversies in Flap Creation", a Supplement to Cataract & Refractive Surgery Today, November/December 2004.

1. Difficulty lifting the flap: Intralase flaps are more difficult to lift. The flap sticks to the corneal bed with connecting bands of corneal tissue, which must be torn away using a mechanical instrument prior to lifting the flap. This has been shown to increase higher order aberrations by 30%.

2. Uneven treatment surface: Eric D. Donnenfeld, MD, of Long Island, New York, and others have noted that the action of the Intralase FS Laser, which creates thousands of bubbles underneath the cornea, destroys tissue instead of separating it, and thus creates an uneven corneal bed or treatment surface.

3. Extensive suction time: Another problem that has been observed with the Intralase FS Laser is a result of the suction ring of the laser remaining on the eye for 40 to 60 seconds, compared to a microkeratome being on the eye for about 5 seconds. This duration leads to the loss of suction in about 1 in 50 Intralase cases, and in only 1 in 1,850 microkeratome cases. It has also resulted in cases of significant patient discomfort and postoperative conjunctival hemorrhage.

4. Flap folds: The Intralase FS laser works by removing corneal tissue instead of separating it. The result is a flap that is smaller than the stromal bed, or treatment area. This can result in the unusual occurrence of postoperative flap folds that may resist treatment by flap repositioning and has required suturing to reduce symptoms and improve visual acuity.

5. Vision fluctuation/Pain: The Intralase procedure takes longer to perform than the microkeratome flap procedure, and Intralase patients are found to have slower visual recovery and prolonged vision fluctuation. One of the more significant complications of Intralase is that a small number of patients had unexplained pain following flap construction. This pain can be quite severe and lasts from days to weeks.

6. Severe light sensitivity: The newly recognized phenomenon unique to the Intralase is track-related iridocyclitis and scleritis (TRISC). Although rare, it is extremely disabling for patients, who often have such severe sensitivity to light (photophobia) that they need to wear sunglasses indoors. This effect can last for 3 to 6 months, and the aggressive steroid therapy being used to treat TRISC has been shown to cause visual loss from optic nerve damage.

7. Increased Inflammation: The Intralase FS laser produces much more postoperative inflammmation, which necessitates the prolonged use of postoperative steroids. Intralase patients are routinely prescribed steroids hourly for one full week, whereas microkeratome patients are prescribed steroids every 2 hours for 2 to 3 days.

8. Slipped flaps/Increased DLK: Although the Intralase FS laser is capable of creating flaps with desired flap thickness, compared with a microkeratome, there are more (although rare) cases of diffuse lamellar keratitis (DLK), photophobia syndrome, and slipped flaps. Surgeons who use the Intralase FS laser have also reported uncommon complications with the laser including epithelial ingrowth, epithelial defect/abrasion, striae/wrinkles. Surgeons have also noted occasional patient complaints of ocular irritation and burning postoperatively.

9. Safety and efficacy: There is no substantiating evidence that the Intralase FS laser produces better postoperative vision, less higher order aberrations, or fewer complications compared with the latest generation microkeratome instruments. The mechanical microkeratome has a well-established record of safety and efficacy, and is used by 95% of all laser vision correction surgeons nation-wide. There is, however, emerging evidence and knowledge regarding an Intralase FS laser-specific postoperative syndrome.

Here is what some doctors involved in recent clinical studies which compared the safety and efficacy of the Intralase FS laser and the Microkeratome have said:

The following excerpts are from Richard L. Lindstrom, M.D., considered one of the world's leading experts in laser and LASIK vision correction, which were published in Refractive Surgery Quarterly, Vol. 4.No. 1, 2004.

"In a recent clinical study, patients who have had LASIK performed with the IntraLase have reported an increase in immediate postoperative edema, a greater amount of pain and not as good visual acuity on the first day than with the mechanical microkeratome."

"Experienced surgeons can achieve flap complication rates of less than one per 1,000 with a mechanical microkeratome, which is similar to that of the IntraLase."

The following is an excerpt from an article published in "Ophthalmology News" August 2004 in reference to Transient Light Syndrome, a possible side effect of the IntraLase procedure.

"IntraLase users said they have never seen the syndrome after making a flap with a microkeratome blade, but only have witnessed the problem after doing so with the IntraLase FS Laser."
Following is a quote from Elizabeth A. Davis, MD, FACS in an article published in "IntraLase or Microkeratome, Controversies in Flap Creation", a supplement to "Cataract & Refractive Surgery Today" Nov/Dec 2004.

COMPLICATION PROFILE, RESULTS, AND ECONOMICS MAKE MICROKERATOME PREFERABLE TO INTRALASE

I have not yet had any personal experience with the IntraLase FS femtosecond laser, specifically because, every time my colleagues and I have considered buying one, we have investigated and researched the system’s outcomes and found them to be inferior to results with a microkeratome. Several surgeons from my group and I have spent a day observing a surgeon who uses the Intralase FS laser, and we were quite unimpressed. We observed poor flaps, prolonged surgical time, inefficient patient flow, patient discomfort, prolonged flap edema, and delayed visual recovery. The Intralase FS laser does not eliminate the risk of a problem with the flap. A surgeon may still get short flaps, buttonholes, etc. Furthermore, the IntraLase FS laser’s flap bed is not as smooth as with a microkeratome, because the connecting bands of stroma that remain at the end of the laser’s pass must be broken with a mechanical instrument prior to lifting the flap.

At the moment, my colleagues and I see no distinct advantage to using the IntraLase FS laser over a microkeratome, and we even see some disadvantages. Hence, we have yet to purchase the device.
~ Elizabeth A. Davis, MD, FACS, is a partner at Minnesota Eye Consultants, P.A. and Clinical Assistant Professor at the University of Minnesota

Dr. Boxer Wachler: “Suction in a microkeratome procedure lasts about three seconds, whereas suction using IntraLase lasts about 15-20 seconds at its fastest. Also, you use less suction on the eye with a microkeratome. I prefer patients to be as comfortable as possible, which is why I prefer the microkeratome. I can share my own personal experience. I have had not had a free (detached) flap occur in five years while using modern-day microkeratomes. Buttonholes (buttonhole shaped flaps) happen rarely, but these have occurred with the IntraLase as well. In other words, flap complications are rare, but they can occur with either microkeratome or IntraLase technologies. The most important aspect is that the patient is in the hands of an expert surgeon. Remember, we are talking about tools, and tools are only as good as the surgeon who is using them. It's like Tiger Woods and a weekend golfer who both use the same top golf clubs. Who do you think will get better results with the same golf clubs?