I am surprised to find that there are no FDA approved topo-driven lasers and the absence of no-touch laser microkeratomes. Common sense tells me that putting pressure on the eye with these mechanical contraptions can't be a good thing for the long term health of the eye. Why are such technologies having difficulty reaching the marketplace?

The Mel laser sounds like a step in the right direction. If anybody has been done with the Mel 70-G, could you please comment on the "QUALITY" of your vision? Everybody focuses on refraction error but the real issue is quality as in night vision etc.

So far I have decided to keep my -6.00 refraction because I don't want to sacrifice quality for reduction in unaided refraction error. I am fearfull of the side affects the current surgery has built in. Thank you for any comments you can provide.

You can say - why has it taken intel this long to finally come out with 1 gigahertz chips for computers - why didn't they develop this years ago

There are many people investigating topography driven lasers - and even more exciting is the wave-front analysis driven lasers. We as ophthalmologists are very excited for this technology as even though the results with LASIK are quite good, we would love to provide even better vision if possible.
The studies looking at topo-driven lasers have yet to show that they provide superior results as compared to our current lasers. So the FDA will not approve a new technology until it makes an improvement in visual outcomes.

As for the status of lasers now - I think the success rate is quite good. My wife had -6.5 diopters of myopia, and since her laser surgery has had better than 20/20 vision. As well, many ophthalmologists and laser surgeons have had LASIK. So the technology currently available is quite good.
I will be happy to answer any specific questions

Bill Trattler, MD
Miami, FL

I originaly had surgery done with a Nidek laser which left me with 20/60 double vision in one eye and an irregular cornea.I learned about the Mel 70 mostly from their web site www.asclepion-meditec.com and had my eye corrected to 20/20 plano.I have had regression back to -.5 but thats not a big deal.The main thing that most people notice after surgery with the mel 70 is the lack of night vision problems and clean vision.My vision was much cleaner after surgery with the Mel 70 as compared to the Nidek.

I have to say that wavefront methods using Hartmann-Shack type sensors look most appealing for quality vision. At least the concept makes sense. Why correct the error in the cornea if the problem lies within the entire optical system? I am encouraged that you were able to get such good quality night vision with the MEL laser but you could be a statistical anomaly. There seems to be little data focused on evaluating the "quality" of people's vision such as night vision available especially for the newer wavefront-based methods.

For those doctors that talk only about the refractive error and 20/20 vision they obviously are not interested in the patient but his money. Two people can have the same refractive error but their vision quality could be significantly different. So the statement "my uncle Joe had it and can now see 20/20" is meaningless because uncle Joe could be seeing 20/20 with double vision and other problems.

I had a chance to read the paper posted on the internet by ??? on the three eyes that were corrected with the wavefront method and they all got 20/10 vision ("supervision"). However only 1 of these eyes was mildly myopic (around -4.50 diopters) the other two eyes were in the -1.00 range. The paper says that the -4.50 eye got more than twice as bad after surgery when evaluating its higher order refractive error and that this may have been due to epithelial growth associated with the healing process. On this basis it looks as if the best vision is likely to be had with a two step process where the goal of the first step is to reduce the refractive error significantly (any laser system/method can be used for this) and the goal of the second step is to produce excellent quality vision (with wavefront methods only). The impact of the healing process after step 2 should be minimal since the amount of cornea removed will be extremelly small. I don't expect excellent quality vision to come after only one surgery unless the refractive error is small to begin with (like the -1.00's of the study). I expect that within 2 years from now to have the wavefront systems in place for good quality vision. I would not take the risk with the current systems available today, last thing I want is a surprise that they don't yet have the equipment to fix.

I totaly agree that most people would thereticaly do much better with a two step process to benefit the most from wavefront supported custom ablations.Many people however are not necessarily seeking legendary 20/8 vision but trying to regain BCVA of 20/20.The Mel 70 T.O.S.C.A system is not wavefront driven but is topographicaly driven and is lately delivering awesome results for some people previously uncorrectable.Asclepion-meditec the manufacturer of the Mel 70 system has just completed their wavefront system called W.A.S.C.A and is starting to generate monograms for the W.A.S.C.A. system.I expect the Mel 70 W.A.S.C.A. system will start clinical trials within the next few months and it will be some time before it is equaled.You can read about this laser system at www.asclepion-meditec.com the most recent laserpost discusses the wavefront system.

Ken, the research paper I was referring to was published this year in the Journal of Refractive Surgery and was titled "Wavefront-guided LASIK: Early Results in Three Eyes". The three authors are from Dresden Germany and used a scanning spot laser with eye tracking (Wavelight/Allegretto which from the description appears similar in capability to the MEL). So the custom ablation you had is not exclusive to the company you mentioned. By the way, the wavefront sensor used by these German doctors was a Tscherning aberrometer and there seems to be a split between the leading researchers as to what is the best way/instrument to measure the wavefront error (there are at least 3 competing technologies and its not clear if any one of them is superior).

After reading some more it became obvious that there is more of this wavefront correction method going on right now with companies like Autonomous, Technomed, Schwind etc. In all cases there seems to be 4 key components to their systems:
1. An instrument to make the LASIK flap
2. A scanning spot excimer laser with eye tracking
3. A wavefront sensor
4. Algorithms/Software to design custom ablations

At this stage no one knows which combination of individual components will work best but I am certain that the winning implementation will be the one which makes the Doctor the least important part to the outcome of the surgery.

John I agree with your last comment especialy,this technology is getting very complex and I would much sooner rely on a computer to make the proper calculations ect. than anything else.Asclepion-meditec in Germany selected the three most promissing wavefront analyzer's and tested them with the Mel 70 before choosing the one they will go with.One reason I like Asclepion-meditec is they spend the money and do a tremendous amount of research before proceding.

To be fair, there are many systems being worked on, and a number of these systems have already treated a handful of patients. These systems include:

The autonomous laser - Dr. Margarete McDonald in new Orleans has treated two groups of patients with wavefront analysis linked to their flying spot laser. The results are very promising, but still early

VISX, which origianlly was a broad beam laser, but now breaks up its beam into smaller segments, has developed an eye tracker and has also treated some patients with customized ablations that I believe were generated with wavefront. I do not have that news release available to me, so I do not know the details, etc.

Lasersite and the B&L technolas are two other systems that are also exploring wavefront, but I have not seen anything written recently on their efforts.

I am not familiar with the Asclepion-meditec laser, perhaps because it does not have much of a presence in the U.S.

I am happy for those people who want to wait for newer generation technologies, but I also feel that the quality of the vision after LASIK is quite high, especially when I screen out patients or situations in which I do not feel LASIK is appropriate, etc. I have performed LASIK on my family member and close friends, and I would not have let them undergo laser eye surgery if I was not confident in the procedure. As well, numerous LASIK surgeons and ophthalmologists have had LASIK - again pointing to the fact that the procedure in its current stae is quite good.

Again, I am hopeful that technologic advances will make LASIK an even better surgery

Bill Trattler, MD
Miami, FL

Dr.Trattler, The Mel 70 is a fairly new laser system the manufacturer Acslepion-meditec gave 2 excellent presentations at the recent wavefront conference in Boston.The presentations were on the first 50 decentered ablation corrections done with the T.O.S.C.A. link.Also the first clinical data on 20 wavefront supported PRK surgery's with spectacular results.You can learn a tremendous amount about improvements in refractive surgery laser equipment and higher quality results at www.asclepion-meditec.com

Dear Dr. Rattler,

It is true that the current eye surgery is better than it has ever been in the past and it is also true that a good percentage of patients get results that they are happy or satisfied with. But after reading countless stories of people whose vision was "royally screwed" (pardon my language) by the current surgery and especially from those who did a fair amount of research into selecting the right doctor etc, its hard for me to arrive at the same conclusion as you did. Of course we are approaching it from different perspectives, you are a doctor performing this surgery as a profession and I am a future patient sitting on the fence trying to evaluate the results objectively.

There is no doubt the current surgery reduces the spherical refractive error but it also increases the amount of higher order ocular abberations and it does so with persistence. This is the main reason behind poor night vision with most LASIK recipients. The researchers at the University of Dresden have recently confirmed this trend and are looking toward custom ablations driven by wavefront measurements to deal with this "vision quality" problem. The source of this is the article "Surf's up: The new refractive paradigm of wavefront technology":

http://www.eyeworld.org/May00/0500p68.asp

Dr. McDonald is even quoted in that article as saying that "the holy grail of wavefront ablations is to improve night vision" and she goes on to say that "the increase in higher order abberations induced by refractive surgery is largely responsible for the decrease in scotopic visual acuity". She also says that this problem (poor night vision) is the number one problem of those treated with the current form of the surgery.

However, it is also unclear at this time if the state of refractive surgery will be significantly or just marginally better 2-3 years down the road. There is just not enough information today to judge the future of wavefront and topo-driven ablations. The question for those sitting on the fence thus becomes, do I go for it now or do I continue with glasses/contacts/perfectvision and re-evaluate a couple of years from now? Of course the answer for each of us will be different.

As for me I already chose to pass on the current form of refractive surgery.

In the present form of LASIK, motivated patients who desire to be able to potentially function without glasses can usually but not always attain this goal with laser surgery. The results of LASIK vary depending on many variables, most important of which is the level of myopia. For patients with 6 diopters of myopia or less, the chance of having difficulties with night time vision is extremely low. This may be because the change is curvature of the cornea is relatively mild. With increasing levels of myopia, other factors become more important, such as pupil size in darkness as well as the preoperative topography and the corneal thickness.
By screening out patients with potential problems, I have been able to provide excellent results with LASIK. LASIK is certainly not the right surgery for everyone, but for those who are excellent candidates, the procedure can be life-changing in a positive way.

Thank you for the information on the MEL-70 laser

Bill Trattler, MD
Miami, FL

Dr. Trattler:
I was a medium myopic before LASIK (-4.00, 0.25 Astigmatism only). Now I have severe problems of any kind (halos, starburst, multiple images) with night vision. You might say I am one of the extremely rare cases. Frankly, after some research, that I should have done earlier, I do now not believe anything stated by a Lasik surgeon without precise statistics. What is extremely rare in numbers? Please advise.
It appears to be proven, that any kind of laser eye surgery increases the number and extent of irregularities at the cornea (abberations), so everybody will have reduced vision acuity at least in low light conditions after LASIK. I is a matter of the magnitude of the irregularities and how sensitive the individual patient reacts. So what means having no problems and what means having problems with night vision?
You are really oversimplifying the problem when you say "extremely rare".

I am very lucky to not have any patients have anything even close to what you are describing, and I am actually surprised that a person with low levels of myopia would have postoperative halos, starburst, multiple images with night vision.
Would you please be so kind as to describe your case more fully so I can better understand how you ended up with your result.
My questions are:
1. What is your current refraction, and what is your best-corrected visual acuity
2. How are your corneal flaps? Do you currently have striae or flap folds.
3. What does your corneal topography look like. Is the contour smooth, or is there irregular astigmatism.
4. What type of laser were you treated with, and what was the diamter of the ablation
5. Do your night time symptoms resolve with glasses or contacts
6. Do your night time symptoms resolve with pharmacologic constriction of your pupil. This is often a useful test.
7. Please make comments on any other aspects of your surgical procedure, postoperative exams, and current conditions that are out of the ordinary.

Thank you for sharing this information, as it is useful to both doctors participating at AskLasikDocs.com as well as patients. This information will hopefully provide insight into why you are having these problems, and thus enable the readers to better understand some of the risks involved with LASIK.

Thank you

Bill Trattler, MD
Miami, FL

Dr. Trattler, here are more data:
Pre-Op I was L. 4.00 0.25 at 007, R. 3.75
1. Current refraction per my surgeon is R.: +1.00, L.: +2.00 -1.25 at 090.
Second opinion doc found less sphere, but additional astig on R. of -0.5 at 010. Strange.
2. Both docs say flaps are perfect.
3. My surgeon: Earlier exam topo showed regular astig. Newer one totally plain, hard to believe.
Second opinion doc gave me in writing that topo shows irregular astig on both eyes, more on the left.
4. Wavelight, treatment area I don´t know yet. Beam dia 1.0 mm as far as I know.
5. Didn´t try contacts, glasses reduce night problems on L. increase problems on R. Multiple red lights. During the day glasses work soso.
6. Did not try.
7. Surgeon was enthusiastic about result immediately after treatment. I realized something went wrong the day after. Blurry vision plus double with L.
After about two weeks (mid April) eyes stabilized to where I am now.
Surgeon is no longer enthusiastic but disappointed. Appears to be very unsure about cause for bad result, however says that my corneas reacted unusual. Says things could improve otherwise enhancement being made after 6 months. Wants to "smooth" L. and reduce hyperoptic. He was very reluctant to tell me refraction until I complained about night driving.
Current status: Seeing halos, starburst w/ and w/o glasses in low light. Most interesting: Looking at red LED, indicating TV is on, I see about 10 - 15 LED´s arranged like a "D" with L. With R. there are only about four LED´s closer together.
In bright light every car has two legible plates with L.
Cannot read without +2.00 readers. Fine print impossible.
R. is fine on distance most of the time, obviously being able to accomodate. L. is never fine, always blurry.
Will make drawings of all the funny things I see and e-mail to you soon.
Will also have third opinion in about two weeks at other laser center that is said to have topo-driven ablation.
I am very concerned the small beam did not ablate in the right position st the right time. Totally unforgiving weapon. If eye tracker failed, how to prove that?
Regards, Gerhard

Dr. Trattler Gerhard had surgery done with the experimental Wavelight laser. The problem was most likely caused by poor eye tracking of the very small laser beam I forget the beam size but I beleive it is .5mm. Asclepion-meditec experimented with different beam sizes and chose the larger 1.8mm beam saying that the smaller beams are unforgiving. The weak link in all these newer laser's is, no doubt in my mind the eye tracking. Asclepion-meditec discusses eye tracking on it's web site www.asclepion.com under Mel 70 pro's and cons of the different systems. This is a must read and understand for anybody wishing to learn about new technology. I have developed a lot of confidence in the Mel 70 because of the EXSTENSIVE research Asclepion has done before proceding with the Mel 70. From what I have learned from the web site the Wavelight laser uses the infared camera eye tracking system which can blind it's self,combine that with a small .5 mm beam going off track and you have a recipe for exactly what happened to Gerhard.

Ken,

From the information available right now on eye-tracking technologies, someone like me would have to favor Autonomous LadarVision. Their eye-tracking system has gotten rave reviews ("starwars technology"). However Autonomous uses a smaller diameter beam (1mm) than the MEL-70 (1.8mm). Now you seem to imply that the size of the beam can't be too small (Wavelight) or too broad (VisX) for best results and that the MEL-70 has the optimal width. Geez, if your information comes from that company's website no doubt they will try to give you that impression. But is there an independent source that can substantiate these types of claims?

I explored the Mel-70 web site, and I was very dissappointed. There is absolutely no clinical information on this web site about the Mel-70 laser, its clinical results, etc.
The eye trackers are a nice feature, but they are by no means critical for excellent results.

Bill Trattler,MD
Miami, FL

Gerhard, An aquaintance of mine just arrived back from Antwerp Belgium where he met Dr.Goes.
Dr. Goes is gaining an excellent international reputation for his work with lasik induced eye problems is this the Dr.you will see?
Dr Trattler if you would like information on the Mel 70 you could try e-mailing he is a Mel rep. I got his e-mail address from my eye Dr.
It is possible that you are correct Dr.Trattler in saying that you can get good results using one of the older laser's that don't have an eye tracker. BUT! The problem I have with the older wide beam laser's is that they develop to much heat. I have read published information lately suggesting this is related to loss of night vision ability. All the major laser manufacturers have gone to the small beam flying spot laser's for several reasons one of them is to avoid the heat developed by wide beam laser's. All of the flying spot laser's require an eye tracker which is part of the newer technology. You will have to learn about the new technology whether you like it or not because the laser manufactures will not go backwards back to wide beam laser's.

Ken:
Dr. Goes is not the one that I will meet soon. But thank you for the information, depending on the result of next second opinion I will contact him.

"You will have to learn about the new technology"

First of all - I routinely meet with company representatives from many of the available laser companies, including autonomous (flying spot technology) and Nidek (slit scanning technology). VISX, which is the laser that I use, was originally a broad beam laser, but it has gone through both hardware and software updgrades over the last few years. The upgrade from over a year ago was the S2 technology. The S2 stands for smooth scan, as the laser beam profile is now broken into small spot sizes that rotate across the cornea providing a smoother ablation than previously.
As far as heat generation, excimer laser technology is general is a cool laser and minimal if any heat is generated by any laser. The risk of night time problems has to do with many factors, but has never been linked to heat generation. Important factors for night time problems include the inducement of irregular astigmatism, and residual refractive errors. As well, high myopes with large pupils at night who undergo LASIK are also at risk for night time problems.
Certain lasers can extend their treatment zone to try to provide wider treatments in patients with high myopia and large pupils at night. The problem is that the wider the diamter of laser treatment, the deeper the ablation to correct the same level of myopia.
For the near future, the Mel-70 is years away from being approved for use in the U.S. You personally may have close ties to this laser, but until it undergoes rigorous study and is approved by the FDA, it will not be available for the avaerage person who is considering LASIK. As well, studies demonstrating the 6 month and 1 year refractive results need to be presented, so that accurate comparisons can be made. Stating one laser is better than another is not helpful unless it is backed by actual data.

Bill Trattler, MD
Miami, FL

Dr. Trattler My close tie to the Mel 70 is because of the fact that I had my left eye damaged with a Nidek laser and fixed with a Mel 70.I'm sure the slit scanning Nidek and also the Visx S2 are on their last harrah! The Autonomous laser according to Dr.Horn has high cornea consumption per diopter and has been plagued with eye tracker problems not to mention the fact that according to FDA data on Dr.Horns site you have a 10% lower chance of acheiving 20/20 vision with the autonomous than for example the chiron 217.SEEK and ye shall FIND the 6 month and 1 year data is available to interested people that are willing to put in the slightest effort. Like it or not the Mel 70 is currently setting the bench mark for other laser manufactures to measure up to and looks to me to be 2-4 years ahead of most if not all laser manufacturers.I will try to find the article I read at eye world on night blindness and give you the URL.I know of only 3 Mel 70's in north america,the main advantage being it's ability to correct otherwise uncorrectable eye's with the T.O.S.C.A. link!

Ken,

It's nice that you had a great result with the Mel-70, but understand that a great result for you does not mean that everyone will have your same success.

Several months ago, we fielded numerous messages from a patient in Colorado who had a number of post-operative problems from the Mel-70.

That laser is not currently approved for use in the U.S. There is a delicate balance between being on the cutting edge and falling off that edge. The point of regulatory agencies in the U.S. is to prevent patients from getting into serious problems. People who want a more aggressive (and riskier) approach can go overseas for surgery, but most, I assume, would prefer to stay on the safer side.

As far as Dr. Trattler falling behind the times, you are significantly off base. There are few cornea and refractive surgery trained ophthalmologists as good as he. You owe him an apology.

Dean Hu, M.D.

P.S. Heat from a broad beam laser?????

I suspect the patient from Colorado might have had laser surgery done with a Mel 60 not Mel 70.It is a common mix up between the Mel 60 and 70,the Mel 60 is an older wide beam laser similar to a Summit Apex. It would be interesting to know more details about the Colorado patient,the 3 clinic's I have come accross from reading the more popular BB's are A-1 and would likely be interested in resolving this persons concerns.

Oh boy, yesterday I went for my annual eye exam at my local OPTOMETRIST here in Los Angeles and the first thing out of his mouth was "have you considered laser vision correction?" It seems like all optometrist in the city are pushing this surgery hard these days.

I have been to 3 different surgeons all of whom have proclaimed me an excellent candidate for the LASIK procedure (refraction OD: -6.25,-1.00x03 OS: -5.75,-1.25x165, 5 micron pupils, 600 micron corneal thickness).

The interesting thing however was that after this guy put me through his corneal topography machine he said that I would NOT make a good candidate for LASIK because my corneas are too flat quoting a curvature of 41 diopters. Now I was really puzzled. Three top opthalmologists in Los Angeles unanimously had told me I was a great LASIK candidate yet this OPTOMETRIST just told me there is a good chance I would not be happy with the procedure. He also went on to say that I should not hold my breadth for any major improvements coming in the next 2 years and there is just nothing that could help me reduce the odds of a bad outcome. Now that was news to me even though I had already decided to wait for the procedure to reach the wavefront stage.

Can Dr. Trattler or any of the doctors here comment on this corneal flatness issue and why a good outcome is not likely in this case? The way I see it is removing 6 diopters from a 41 diopter cornea still leaves you with 35. Is 35 a bad number and if vision quality suffers what would be the nature of the final outcome? Blurry vision, hallos, what? Also would you expect a wavefront designed ablation to improve the quality of the final outcome?

Thank you very much for any responses.

John

i agree with the other doctors who posted responses here.... there is no absolute level of flatness where a person wille experience poor vision. and while the optom was being conservative, he didn't have a full grasp of the complexity of the situation..as the other doctors have said, there is not a strict one to one ratio between what we get on the correction and what appears on the topographic map. so it is unlikely that you will in fact be too flat.

waitinf for wavefront technology is a personal choice, and the technology is fascinating, but it will be several years before we know what is the best method of using this technology. should we do the measurements with eyes dilated or not? in the dark or in the light? is the picture we get at one moment in time going to give you good (excellent ) vision at all conditions? we'll all have to wait and see before we can fully stand behind this new technology.

debra tennen, md

I hate to break this to you - but your optometrist is wrong to say that your cornea is too flat. There is not a one to one relationship between the Preop and post op K's for a given level of myopia.
I will try to get some examples early next week of real patients - where I will put down their preop K's, their preop myopia, and then their postop K's and postop refraction. It turns out that there is closer to a 50% correlation in general, but there are many factors that can contribute.
I hope this is helpful (and interesting)

Best of luck

Bill Trattler, MD
Miami, FL

Your corneas are not too flat. There are some reports that best-corrected vision after LASIK in corneas flatter than 35 may suffer.
You actually would be closer to 36 after LASIK because each diopter at the spectacle plane equates to less at the corneal plane.

Either way, be careful of any one who pushes anything too hard. A lot these folks may have significant financial interests.

Good Luck ,
Dean Hu

Dear Doctors,

Thank you very much for your replies. Your opinions are in agreement with the 3 opthalmologists I have consulted that don't think my corneas are too flat for surgery. After talking with my optometrist again about this he said that I am a "borderline" case. This is based on his experience with other cases with corneas as flat as mine that he had provided LASIK post-op care.

Apparently his business model allows him to collect two fees first for recommending good LASIK candidates to local area LASIK surgeons and second for providing post-op care to those who elect to have it done. I didn't know that optometrists can provide post-op care for LASIK and I don't really care. What has me baffled is his experience with people with flat corneas not turning out happy with their outcomes.

As we know from current studies, in generall 1% of all LASIK recipients are not happy with the results of the procedure and would not do it again if they had the choice. My optometrist thinks that this percentage is mush higher amongst those patients with flat corneas (like mine) and my level of nearsightness and this is why he advised me against it. Although I agree with all of your statements that the final outcome is likely to be due to a combination of variables (and not just corneal flatness) I am still not clear as to what the danger for me really is. In other words what I can expect to go wrong with the surgery and be prepared for it before hand.

I understand your concern, as there certainly are risks with LASIK. The risk for a person with 6 diopters of myopia and K's of 41 are not much higher than for people with k's greater than 41. Although your optometrist may have taken care of a few lasik patients, your best source of info will be the LASIK surgeons who have experience with patients that have similar characteristics. In fact, you may want to ask your surgeons for the names of patients who had LASIK with k's in the 41 range and 5-9 diopters of myopia.
There are many variables when considering the risks of LASIK and the success of LASIK - and it is good that your are investigating things thoroughly prior to having LASIK

Best of luck

Bill Trattler, MD
Miami, FL