COMING INTO FOCUS
A look at one failed surgery and how new LASIK technology might fix such mistakes

SAN FRANCISCO, Calif.--(San Francisco Chronicle Magazine)--Nov.9, 2003--

When Dr. Edward Manche tells the story, he changes the names to protect the privacy of his patient. The only problem is it sometimes starts out sounding as if it might be the setup for a bit of ophthalmological black humor:

Lady goes into a clinic for laser eye surgery. Afterward, the doctor comes over and tells her, "Congratulations, Miss Jones. Everything went fine." She looks at him, puzzled, and not only because she can barely see his face. "That's good," she says, "but I'm Miss Smith."

It's no joke.

"Miss Smith," in this case, turns out to be Gena Steward, a crime lab technician for the Livermore Police Department, who is now being treated by Manche. He hopes he can repair the damage done by another surgeon, who performed someone else's LASIK procedure on Steward's eyes.

She needs her eyes even more than most.

Steward studies fingerprints and analyzes evidence at crime scenes for a living. Although she never wore glasses in high school, by her mid-30s she was finding it difficult to get by without them, unable to make out street signs and license plates unaided. But sometimes the glasses interfered on the job,

such as when she had to put on self-contained breathing gear at suspected arson scenes.

On Oct. 17, 2000, Steward went to Horizon Vision Center in San Leandro to have the popular LASIK procedure - "laser-assisted in-situ karatomileusis" - done on both eyes, convinced it would free her of the hassle of glasses or contact lenses. The surgeon was Dr. David B. Davis II. He was a veteran, licensed to practice medicine since 1959, father of someone Steward had known since high school. Some 20 years before, Davis had performed cataract surgery on Steward's grandmother.

Davis was one of a team of surgeons at the San Leandro center, part of a network of seven "state-of-the-art laser vision correction centers" operated by the Horizon chain in the Bay Area and Sacramento. The chain boasts a combined track record of more than 50,000 successful procedures.

Steward's case is not one they boast about.

"Miss Jones" was to have been another patient at the center. She, too, had an appointment with Davis on Oct. 17. Hers was to be his first case of the day. Steward was to be second.

Both women's eyes had already been examined. Early that morning, a technician fed the data for "Miss Jones," who was severely nearsighted, into the computer that guides the laser. Based on these settings, the laser would sculpt her cornea just so, within a few seconds eliminating a lifetime of vision problems.

But "Miss Jones" never showed up that morning.

"Miss Smith" - Gena Steward - wishes she hadn't, either.

Now 68 years old, Davis has since retired and moved to Washington state.

"This was very traumatic for me," he said during a telephone interview, although he insisted he didn't quit practicing medicine because of the Steward case. "I've never had anything like that happen before."

He was forthright about what happened, even after I had to decline his request to keep his name out of it. He said he considers the matter over as far as he is concerned, and that he hopes Steward is on her way to recovery now that she is in Manche's capable care.

"For reasons which I don't remember," he said, "the first case was held up. So Gena was brought in, and the technician apparently thought she was still the patient from the first case. The calculations for the first case were left in the computer on the laser. I did not check the readings. That was my mistake there. I'd been doing them so long I think I just took it for granted. That's how it happened. So she was treated for a very severe nearsighted amount, when she was not."

Steward had no idea what had happened when she was led into a darkened room after the procedure. Everything was a blur, she said. Nobody told her so at the time, but she already had a strong inkling something was terribly wrong.

"I was sitting in this dark room - blind," she recalled. "I was scared to death. But I didn't know at the time if this was normal or what."

It most certainly was not normal. Steward had just become one of the 1 percent or so of LASIK patients who wind up seriously unhappy with the results of one of medicine's most successfully marketed elective procedures.

Attracted by ubiquitous advertising and growing word-of-mouth from satisfied customers, nearly 1.3 million Americans are expected to have a LASIK procedure this year, up from a little over 1.1 million in 2002. Six million have had it since 1995, when the first laser equipment for vision-correcting eye surgery was approved by the U.S. Food and Drug Administration.

In the early days, about 10 percent of patients wound up with some sort of complaint, such as seeing halos around lights and other night-vision problems. By all accounts it was an unacceptably high problem rate for an elective procedure, and doctors have been successfully trying to improve outcomes in recent years.

"In the last five years, that's dropped to about 3 percent. But even at 3 percent, if you are talking about 6 million people, it's a big number," said Dr. Daniel Durrie, an eye surgeon in Kansas City and a national spokesman for the American Academy of Ophthalmology.

He and other doctors warn that anybody considering a LASIK procedure needs to keep the risks in mind. Most of the worst cases of post-LASIK complications involve problems with the surgical flap - a circular outer layer of the cornea that is cut and peeled back before the laser is applied, then flopped back over the corrected eye, healing back into place.

The little LASIK flap that is raised up can wrinkle, or tear if it's too thin, or get a hole in it.

That sort of complication used to happen about once in every 100 cases. Now the flap problems have been

reduced to about one in every 1,000 cases. Some very recent statistics, according to Durrie, suggest the real risk nowadays, in the hands of a capable surgeon using the latest equipment, might be as low as one in 10,000.

But as Steward's case shows, a badly done LASIK flap is hardly the only thing that can go wrong.

Dr. Richard Abbott, a clinical professor of ophthalmology at UCSF Medical Center, has done laser eye surgery on hundreds of patients, including his own wife, with excellent results. But he has declined to have it done on his own eyes, even though he is legally blind without glasses, 20-200, with nearsightedness and astigmatism.

"The key thing patients need to know, which is obvious to those of us in this profession but is not obvious to a lot of people, is that this is surgery,

and in surgery things can wrong. There can be complications, and sometimes they can be very difficult to fix," he said.

"All kinds of things can go wrong," he continued. "There may be problems in the mechanics of doing the procedure. There can be physician problems, equipment problems, data problems, transfer of data problems. The data entry into the laser may be off, and that might be missed."

There can be patient problems, too.

"Most people have a very high expectation for this procedure," Abbott said. "They end up with less than perfect results, and that makes those people very unhappy. Most people do extraordinarily well, but it's not for everybody."

After about an hour in the dark after her surgery, someone told Steward she could go home for the day, but to come back the next day for the standard post- operative followup check of her eyes. Davis tried to reassure her, Steward recalled, suggesting the extreme blurriness she was experiencing should clear up by the next morning.

She was given no explanation of what had happened, no hint of any glitches, even though Davis said he realized what had happened soon after the procedure was over. He just decided to keep it to himself for a while.

"I was absolutely in shock when I found out," he said. "I was going to tell her immediately, and then I consulted with another physician, who said the result 'may not be as bad as you think, so wait a little while, let it settle down. Fit her with contact lenses and make sure she's seeing well, and then talk about it.' "

"That was my big mistake," Davis said. "I should have told her right away."

Steward, unaware, didn't know enough to ask why she wasn't given a name tag to wear. Because she couldn't see the road, much less make out street signs, a friend drove her home, where she spent most of the day in bed, feeling her way around when she had to get up.

Her father took her back for the follow-up exam the next morning. She was more than a little upset. Even though she had been warned to expect some cloudy vision to persist for a while after the surgery, something just didn't seem right.

"My dad had to lead me by the arm into the doctor's office," Steward said. "He examined me, and said I had had an adverse reaction to the procedure. It was just something in the way my body reacted. He wouldn't explain it to me beyond that. He wanted to have me fitted for contacts. He just said the optometrist would fit me for contacts to try to get me to see better."

Davis knew exactly what had gone wrong. But he said he was hoping that Steward's eyesight would improve over time, or that another operation might be able to fix any residual defects.

Sometimes, a situation that looks like disaster may look much different as the eyes heal and the cornea gradually changes contour. Sometimes, even big overcorrections with a laser have a tendency to ease back toward normal on their own. And sometimes, even the stopgap measures don't work: Steward's eyes were in such bad condition it proved impossible even to make contact lenses work properly anymore.

"Deep in your heart, you think, 'This is not really happening,' " Davis said.

In Manche's Stanford office, the big buzz lately is the arrival of yet another new technology. He is one of about 1,500 surgeons across the country certified to use the new $65,000 system called "CustomVue" by manufacturer VISX of Santa Clara, based on a technology known generically as "wavefront."

It uses multiple "lenslets" and a laser beam that can be fired into the eye,

then measured precisely in a couple hundred different locations as the beam bounces back off the retina. Any aberrations, any photon-slowing thicknesses in the cornea that shouldn't be there, will be picked up by the software. Then,

once that data is captured, the same information can be used to guide the laser that zaps away - "ablates" is the preferred word - the offending corneal areas.

"It's very good for treating irregularities in the shape of the cornea that we could not treat up until now, whether the irregularities were induced by a LASIK procedure or were something a person was just born with," said Dr. Roy Rubinfeld, a LASIK specialist who practices in the Washington, D.C., area. "It's one of the most important things to come along in LASIK for a long time."

This turns out to be the very same technology that has revolutionized astronomy, where it's called "adaptive optics." Telescopes so equipped can measure light-distorting aberrations in the atmosphere, then make appropriate mirror adjustments for a clear view of distant objects.

In the eye doctor's office, it might be just the ticket for fixing Steward's badly fried corneal tissue. To illustrate how it works, Manche and an assistant turned off the roomlights and sat me down in front of the testing device, a chunky beige box with a chinrest and a place to lean your forehead so your eyes are trained straight ahead.

A blinking light came on. I focused on the light. Manche was looking at a screen off to one side. First one eye, then the other. The lights came back on.

We did it all again in front of a different machine in another examining room,

which produces something called "Orbscans."

I was handed several color printouts, pairs of images, one per eye. "Something for your refrigerator," Manche said.

One image was an "acuity map," which looked like a green kidney bean floating in yellow soup, slivers of orange carrots at the edges. The other image showed "wavefront high order aberrations" - wiggly amoebas of some sort, splotches of different shades of green and blue.

There was a table showing all my "Zernike coefficients."

I had one pupil diameter of 4.32 millimeters. The other was 5.08 milimeters.

There was a "posterior float" and an "anterior float,"

depicted as circles with indecipherable but alarmingly asymmetrical splotches of color. There were words like "astigmatism" and "effective blur," and numbers like "-0.82 DS" and "+0.61 DC x 45 degrees@ 12.5 mm (4.0 RX calc).

To me, squinting, it looked dreadful.

I have never had to wear glasses until recently, as my eyes have been getting noticeably weaker with the onset of middle-aged presbyopia - a problem that cannot be treated with lasers. Except when I am trying to read, I can skip the glasses even now. And now here I was being told that my pupils weren't even the same size.

In fact, Manche said, I had little to be concerned about, other than some myopia and a bit of astigmatism in one eye, which the last eye doctor

I visited told me about anyway.

Steward's pictures all look about the same, but to a practiced eye tell a much different story. Her pre-operative readings of minus 1.25 diopters - a neutral zero is the ideal - in each eye with no astigmatism meant just minor nearsightedness, something seemingly tailormade for a LASIK operation to correct.

But after Davis was through, she was way overcorrected, plus 3.50 diopters, with an irregular astigmatism now in both eyes. She had 20-45 vision before; after the surgery, she was 20-200.

Guys at the Livermore P.D., who were "extraordinarily supportive" throughout her ideal, Steward said, now couldn't resist a little gentle

humor of their own, congratulating Steward on having just become "the world's first blind fingerprint examiner."

Wavefront" is Steward's hope out of the mess. It amounts to a new way of testing for defects in the eye that provides much more detailed readings than before, allowing comparably more exact corrections. Instead of a single lens in the device used to find the problem based on a lot of averaging over the entire surface of the cornea, the wavefront device breaks the cornea into separate areas, each of which is corrected based on its own peculiarities.

In a field already full of hype, expect even more: Wavefront has been likened to an evolutionary leap in laser eye correction, like high-definition television compared to standard TV.

"Results have been absolutely remarkable," Rubinfeld said.

Wavefront gives doctors the ability to fix "defects in vision we weren't even picking up with the existing testing devices," he added. "We can treat people who might not find their night vision is as good as they would like, or have some other type of symptom and would like to see better."

The real change, doctors say, is not so much in the laser operation but in the detection of the underlying problems. Wavefront technology could lead to better contact lenses and eyeglasses, they said, where laser surgery is not the chosen option.

"We're in a new era of testing eyes," Durrie said.

The new technology is geared to finding "higher-order aberrations" that were never apparent before, except to the people trying to see through them. In many cases of post-LASIK complaints, surgeons could find no explanation for the problem, relying on standard testing methods.

Problems may arise because some people are abnormal in the degree of slope across the pupil. Someone who measures slightly myopic at the center of the eye could be much worse out at the edge.

"You could correct the center, but when they look at lights at night they see halos because we didn't correct the edges enough," Durrie said. "Now we can diagnose it and correct it with these new lasers."

But some cautionary notes are already sounding.

For starters, the FDA approval for the "wavefront" devices only applies to procedures done on "virgin eyes" - eyes that have not had a previous laser procedure. Clinical trials have not been done yet covering retreatment cases, although doctors are free to use the new lasers on such patients as medical judgment determines.

There's not enough follow-up data, at least not from patients in the United States, to predict how people will fare in the long term, despite the very encouraging early U.S. results and longer experience in Europe.

Dr. Stephen McLeod, vice chairman of ophthalmology and co-director of the refractive surgery service at UCSF, is adamant that people understand the limits of the new technology.

It does not appear to be well-suited for fixing "a very abrupt irregularity in the cornea, one that happens to have a very focal location, for example, a little lump or fold near the entrance area of the pupil," McLeod said. Such aberrations, which may arise naturally or from a botched LASIK procedure, can result in "smudges" or blurry spots in the field of vision.

A tiny "pinpoint elevation or a very well-defined fold" in the wrong spot can seriously distort vision but "the laser doesn't do a very good job of pinpointing the region that needs to be brought down," he said.

A certain percentage of people who have had a laser correction and are unhappy with the aftermath have "a very sharp transition from normal cornea to abnormal cornea," McLeod said, "and that can be very hard to treat."

Registration, or lining up the laser with the eye, is also "a very tricky problem," he added.

For Steward, it will take a little more time to tell. She sued Davis, settled out of court for a tidy sum, which she has tried to keep private but turned out to be enough to allow her to move into a larger new home near work.

Manche tried to help her eyesight starting back in December 2000, long before the wavefront system was ready for widespread use. He recommended waiting a few more months after the initial surgery, to allow the cornea to achieve a stable shape, and then do another laser correction on Steward's right eye, hoping to get at least one eye close to normal.

After the follow-up corrective surgery in May 2001, Manche was able to improve her vision in the re-treated eye to 20-50, but she still had the astigmatism. The best a contact lens could achieve was 20-45. One optometrist said her cornea had been "warped" from the procedure in Davis' office, making it impossible to fit a lens properly.

A month later, in June 2001, Manche zapped Steward's left eye again, and this time got much better results: 20-15, sharper vision than normal. At work, Steward trained herself to use this left eye for all the tough detail work.

No longer "blind" in both eyes, she decided she could afford to wait for the wavefront system before submitting for what she decided would be her last attempt to regain normal vision in her damaged right eye.

"I just don't want to go through it again," she said.

The final surgery was done in early September. A photographer and I were invited in to watch. It was all over in surprisingly short order. Other than peeling back the little flap on the surface of Steward's eye, it seemed little more daunting than the testing routines Manche had put me through a couple weeks earlier.

After a few weeks, Steward found she could make out the letters on the 20- 20 line on the eye chart with both eyes. Manche said he was pleased with the progress and anticipated further improvement as the latest eye to be treated heals.

Steward was also pleased. Not overjoyed, exactly, but certainly happier than she was before.

"The surface of my eye was all warped before, and now it's all very smooth, " she said.

Her image of the 20-20 line isn't nearly as "crisp and focused" as she would like.

"I can see the letters but they're still a little blurry," Steward said. "But my left eye is really good. My right eye is pretty good. No glasses. No contacts. So I'm pretty happy with that. I can do my work now, no problem."

She can even make out road signs again.

Carl T. Hall is a science writer for The Chronicle.