"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith.
Cleaner LASIK: Is it Possible?http://www.ophmanagement.com/article.aspx?article=86452
This from a doctor who was fined $1.1 Million from the FDA for damaging 125 patients...
IOL calculations after refractive surgery need extra care
Excerpt: The topic of IOL implantation after refractive surgery and power calculations arose a few years ago. However, Dr. O'Brien noted that now this situation is arising on a daily basis in practices as the number of refractive procedures increases each year and as the population ages. "There has been a question of whether laser refractive surgery is accelerating the development of cataract. This is controversial, but I see it more and more often in my practice," he said. Dr. O'Brien is professor of ophthalmology and director of the Refractive Surgery Service, Bascom Palmer Eye Institute, Miami. The problem, he pointed out, is that the patients who have undergone refractive surgery and then develop cataract are different in mindset from the traditional patient with cataract in that they have extraordinarily high expectations; they want immediate results; and they want no surgical discomfort, sutures, or downtime after the procedure.
"These patients who develop cataract after refractive surgery want a perfect outcome. They are potentially frustrated and angry because their quality of vision has suffered as the result of the refractive surgery, and the results may be unpredictable. Interestingly, incorrect power is the most common reason for IOL explantation. This is the result of our not being able to determine the power as accurately as we would like," he stated and advised exercising extra care with these patients.
"Successful LASIK" is an oxymoron
Found on LasikFlap bulletin board: http://www.lasikflap.com/forum
The flap never heals. It cannot heal. All it can do is form a scar at the margin of the flap which is only 28% as strong as a normal cornea. The flap itself does not bond to the underlying cornea and can be dislodged or lifted years later.
The corneal nerves that play a vital role in tear production never fully regenerate. A scientific peer-reviewed study proved that at 3 years post-op the corneal nerves are still less than 60% of pre-op densities. LASIK induced dry eyes is common and for many patients is a life-long sentence.
The suction ring used during the cutting of the flap damages the delicate structures inside the eye including the retina, vitreous, and optic nerve. Many patients report increased floaters (posterior vitreous detachment) after LASIK, and some experience retinal tears or detachment, lacquer cracks, macular holes, macular hemorrhages, optic neuropathy, and retinal vein occlusion.
LASIK corneas are not as stable as normal corneas and can begin to bulge weeks, months, or even years later, potentially resulting in loss of the cornea. This bulging is a response to the normal intraocular pressure. A LASIK-weakened cornea sometimes can no longer withstand this outward force. The FDA used a best-guess safety limit of 250 microns of cornea under the flap when LASIK was approved. Since then it has been shown in the medical literature that 250 is not a safe limit, even though the vast majority of LASIK surgeons, who are too busy doing LASIK to follow the research, are still using an unsafe limit of 250 microns. And the FDA does not have the backbone to modify the approval, allowing the LASIK industry to continue this unsafe practice that jeopardizes the well-being of millions of patients.
There is permanent damage in 100% of LASIK corneas -- debris in the space between the flap and the underlying cornea, undulations and microfolds in the Bowman's layer -- presumably because the flap doesn't fit to the altered corneal bed, haze, epithelial cells under the flap, acutely and chronically reduced keratocytes, epithelial thickening, collagen fibril disorganization, collagen lamellar disarray, and abnormalities of the Descemet membrane.
Quote from one peer-reviewed study: "However, the presence of pathologic findings up to 7 years after LASIK indicates that the process of corneal stroma wound healing never completely regenerates histopathologically normal corneal stroma."
Loss of night vision quality after LASIK occurs frequently, according to a 2002 report by the American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.
And then we have the problem of the white wall of silence. Doctors are pressured by their peers not to testify for patients who are victims of LASIK malpractice. They are threatened by their own insurance carriers, which could put them out of business. And they are concerned about giving LASIK a black eye by helping a patient seek justice for the harm done to him or her in a public forum like a court of law. They cave in to the pressures, leaving patients without any recourse -- medical, legal or otherwise. So doctors just get away with it and standard of care and informed consent continue to be basically non-existent. And the FDA says it's not their problem (they regulate the devices, not the doctors).
So who's looking out for the patients? Who's going to warn them that 1/3 of their corneas will be nearly sliced off, leaving them with a structurally weakened cornea that can begin to bulge years down the road? Who's going to warn them of the seriousness of LASIK-induced dry eyes, that the nerves never regenerate, and that painful dry eyes can be permanent? Who's going to warn them that LASIK, all LASIK -- conventional and custom, induces higher order aberrations in all virgin corneas, effectively reducing the quality of their vision? Who's going to warn them of the damage the suction ring can do to the structures inside the eye? Who's going to warn them that the flap never heals?
You would think doctors would be protecting patients. Wake up and smell the coffee. Money is what drives them, not a desire to heal the sick. They don't deserve to be called doctors. They are no better than used car salesmen.
American Academy of Ophthalmology. For some patients, particularly those with large pupils, this complication can be debilitating. Since this is a "frequent" problem after LASIK, I wonder how many of the approximately 8 million Americans who have had LASIK are out there on the roads at night endangering their life and the lives of others who share the roads with them? A recent study showed that up to 50% of LASIK patients are impaired when driving at night. Yet this serious threat to the public health is down-played and swept under the rug by the LASIK industry.
Mistakes/ErrorsJOURNAL OF REFRACTIVE SURGERYVol. 22 No. 3 March 2006 Dan Z. Reinstein, MD, MA(Cantab), FRCSC; Cynthia Roberts, PhD
Excerpt: "Some of the evidence pointing to the impact of corneal biomechanical properties on surgical outcomes lies in the measurement of intraocular pressure (IOP), both before and after refractive surgery. It is well known that measured IOP is reduced, on average, following a refractive procedure. It has been assumed that this is the result of reduced curvature and thickness in myopic procedures. However, Chang and Stulting performed a retrospective review of over 8000 myopic LASIK patients, and determined that although measured pressure was reduced on average by approximately 2 mmHg, the range of change was approximately +10 to -15 mmHg. Every patient in this population had reduced thickness and curvature, and yet almost half of them had an increase in measured IOP.
Clearly, the artifact in IOP measurement cannot be explained by thickness alone, and “correction” of measured IOP postoperatively using a linear correction factor based on thickness is problematic. This leads to the conclusion that refractive surgery likely alters the fundamental biomechanical properties of the cornea.
Lasers or Surgeons: What's really the cause of high retreatment rates?
“I had one time where I had to put the flap back with a flashlight because the illumination light went off so I couldn’t figure out where the flap was,” Dr. Rubinfeld said.
Interface fluid after LASIK
J Cataract Refract Surg. 2001 Sep;27(9):1526-8.
We report a case in which raised intraocular pressure (IOP) was associated with interface fluid after uneventful bilateral laser in situ keratomileusis (LASIK). The patient presented with diffuse lamellar keratitis in both eyes 3 weeks postoperatively that was treated aggressively with topical corticosteroids. A steroid-induced rise in IOP resulted in interface fluid accumulation and microcystic edema. Measurements with the Goldmann tonometer revealed an IOP of 3.0 mm Hg in both eyes. However, Schiotz tonometry recorded a pressure of 54.7 mm Hg in both eyes. Reduction in the dosage of topical corticosteroid and medical treatment of the raised IOP resulted in resolution of the microcystic edema and interface fluid accumulation. This case highlights the inaccuracies of IOP measurement after LASIK and the resulting complications.
LASIK: three unexpected complications
J Refract Surg. 2001 Mar-Apr;17(2 Suppl):S177-9. Rosa DA.
PURPOSE: To report unexpected outcomes in three patients after uneventful laser in situ keratomileusis (LASIK) performed using the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical).
METHODS: LASIK was performed with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical) in three patients.
RESULTS: In three patients, unexpected outcomes were observed. One patient treated for -3.00 D of myopia presented with a central island. One patient treated for +2.00 D (+1.00 x 90 degrees) of hyperopia in both eyes ended up emmetropic in one eye and overcorrected in the fellow eye. The third patient with -12.00 D (-2.00 x 180 degrees) of myopia was treated as -8.60 -1.00 x 180 degrees and at last examination was +4.00 D. During these sessions, all other patients treated were within +/-0.50 D of emmetropia.
CONCLUSION: After LASIK with the Nidek EC-5000 excimer laser and the Hansatome microkeratome (Bausch & Lomb Surgical), unexpected outcomes may still occur, despite controlling all the usual variables.
Oculocardiac reflex in a nonsedated LASIK patient
J Cataract Refract Surg. 2002 Sep;28(9):1698-9.
Baykara M, Dogru M, Ozmen AT, Ozcetin H. Uludag University Faculty of Medicine, Department of Ophthalmology, Bursa, Turkey
A healthy 21-year-old man had laser in situ keratomileusis (LASIK) in the right eye for a refractive error of -7.0 diopters. The electrocardiogram findings and heart rate were recorded before LASIK; during eye lid speculum insertion, vacuum application, corneal flap preparation, and excimer laser keratectomy; and after the procedure.
The pre-LASIK heart rate was 90 pulses/min. Severe bradycardia of 40 beats/min developed during vacuum application, and the procedure was terminated. Severe bradycardia caused by an oculocardiac reflex may occur during LASIK, and patients should be closely monitored during the procedure.
LASIK complication: loss of electricity to the microkeratome during the forward pass
Acta Ophthalmol Scand. 2003 Oct;81(5):530-2.
CONTEXT: A 32-year-old woman was scheduled for myopic laser in situ keratomileusis (LASIK) because of myopia and anisometropia caused by retinal detachment surgery.
CASE REPORT: During surgery, a sudden malfunction of the microkeratome during the forward pass was experienced. It was not possible to reverse the blade manually along the suction ring. Moreover, disconnecting the suction from the control unit did not help at first, because the suction ring was firmly attached to the ocular surface. However, detaching the suction line from the control unit aborted the vacuum and allowed the surgeon to turn the whole microkeratome backwards, mimicking the normal blade movement. Finally, an almost normal flap was observed, and the operation was successfully completed. Afterwards, the wire to the electromotor of the microkeratome was found to be broken and subsequently replaced.
CONCLUSION: This type of unforeseen microkeratome malfunction may result in serious flap or other complications.
Refractive surprise after LASIK
Arch Soc Esp Oftalmol. 2005 Sep;80(9):547-9. Related Articles, Links
CASE REPORT: A female patient underwent laser in situ keratomileusis (LASIK) in both eyes. The final degree of astigmatism in her left eye was double the preoperative value due to an error in data management. Complex surgery to both eyes was necessary to resolve the mistake.
DISCUSSION: Complications in refractive surgery can occur, however errors in data management must be minimized by double-checking. Solutions to resolve the errors made can be difficult and the entire staff must share responsibility to avoid these undesirable outcomes.
Failure to verify treatment parameters can lead to LASIK errors
TOP STORIES 3/24/2006
Quote: In the last case, the patient allowed the surgeon to call him “José” several times, believing the surgeon was making a joke. Only after one eye had been treated incorrectly did he clarify his name was “Carlos,” Dr. Sonal said.
Turn Around These LASIK Letdowns
Review of Optometry
Excerpt: For most carefully chosen patients, LASIK continues to improve their quality of life significantly. However, the popular media that once portrayed LASIK as a somewhat miraculous procedure now tell horror stories of people visually disabled by LASIK gone awry.
Read the entire article at:
What's Next for LASIK?Ophthalmology Management Issue: September 2004
Outcomes are better than ever, but its place as the dominant refractive procedure is now in doubt. By Jerry Helzner
December, 2006 -
"Make sure the first patient you enroll feels like you have been doing this for years..."
EyeWorld October, 2005
Stephen S. Lane, M.D.:
“There has been a lot of interest in ectasia worldwide because it is a lose-lose situation for both patients and surgeons."
However, I believe there are too many holes in available literature reports to allow risk factors to be conclusively defined. Likely, there are other variables that are not measured or that we don’t know how to measure that account for this complication,” said Dr Binder. He added, “Any of the current recommendations for safe patient selection are guesswork and unproven."
Why do you not use the Excimer laser?
Recurrent Regression After Hyperopic LASIKFrom Cataract & Refractive Surgery Today, 2003 http://www.crstodayarchive.com/03_archive/0602/crst0602_101.html
Refractive ChallengeBy Mitchell C. Shultz, MD Excerpt:
"Through my 6 years’ experience performing refractive surgery, I have found that women in the perimenopausal age group have a significantly increased risk of dry eye syndrome after LASIK when compared to other subgroups of patients. LASIK-induced neurotrophic epitheliopathy (LNE) caused by the transection of the sub-basal nerve fiber bundle and photoablation of the superficial stromal nerves sets the stage for postoperative dry eyes. The combination of LNE and hormonal changes affecting meibomian secretions leads to a chronic tear film dysfunction that is more prevalent in peri- and postmenopausal women. For this reason, I am leery of performing LASIK on these patients."
http://www.osnsupersite.com/view.asp?rID=23169Eric D. Donnenfeld, MD:
Quote: A 45-year-old woman came in for routine LASIK. I’m doing my LASIK, I hand off the keratome, and they blow out the keratome. And suddenly there is no flap. Now we’re looking for the flap, but we can’t find it. And all of you know how to find out if spaghetti is done. You throw it against the wall. If it sticks, it’s done. And that’s exactly what happened. The cornea ended up against the wall. We find it, but now it’s been sitting on the wall for about 5 minutes.
http://www.ophthalmologytimes.com/ophthalmologytimes/article/articleDetail.jsp?id=405941 R. Doyle Stulting MD:
"Ectasia is estimated to occur in one of every 2,500 patients undergoing LASIK, Dr. Stulting said, "but this may be an overestimate because of current exclusion criteria. It also may be an underestimate because of limited follow-up." Reported cases of ectasia have been diagnosed up to 4 years after LASIK, he added, also noting a case of ectasia that required corneal transplantation 13 years after PRK. "Pathology in this case suggests cell loss and abnormalities of keratocytes, leading us to wonder whether defective keratocyte metabolism could make ectasia more likely and to wonder whether mitomycin C might increase the long-term risk of ectasia," Dr. Stulting said."
Analysis of ectasia after laser in situ keratomileusis: Risk factors
JCRS Analysis of ectasia after laser in situ keratomileusis: Risk factors Volume 33, Issue 9, Pages 1530-1538 (September 2007) Perry S. Binder
Quote: The mean flap thickness measured at surgery by subtraction pachymetry (n = 350 eyes) was 113.1 ± 29.3 μm (range 29 to 221 μm). Quote: The RST measured directly after the laser ablation, recorded in 250 eyes, ranged from 102 to 384 μm.
If the eyes in that study had achieved flap thicknesses in excess of 200 μm, which is not uncommon with the microkeratomes used at that time, the residual thicknesses would have been less than 250 μm in all cases.
Correlation Between Attempted Correction and Keratometric Refractive Index of the Cornea After Myopic Excimer Laser SurgeryJournal of Refractive Surgery Vol. 23 No. 5 May 2007 Giacomo Savini, MD; Piero Barboni, MD; Maurizio Zanini, MD Quote:
Inaccurate calculation of intraocular lens (IOL) power after refractive surgery has been the subject of considerable attention in the past decade. It is widely recognized that using videokeratography underestimates corneal flattening after myopic excimer laser surgery. As a consequence, standard keratometric values lead to IOL power underestimation (with subsequent hyperopia) in eyes that have previously undergone myopic photorefractive keratectomy (PRK) or LASIK.1,2
Effect of Punctal Plugs in Patients With Low Refractive Errors Considering Refractive Surgery
Journal of Refractive Surgery Vol. 23 No. 5 May 2007 Monica B. Khalil, MD; Robert A. Latkany, MD; Mark G. Speaker, MD, PhD; Guopei Yu, MD, MPH
Quote: Retreatment rates up to 15% have been reported with conventional LASIK.6 However, retreatment increases risk of complications, such as diffuse lamellar keratitis, epithelial ingrowth, striae, infection, prolongation of dry eye, and flap dislocation. These complications are potential causes of decreased best spectacle-corrected visual acuity (BSCVA).
Role of the endothelial pump in flap adhesion after laser in situ keratomileusis
J Cataract Refract Surg. 2004 Sep;30(9):1989-92. Bissen-Miyajima H, Nakamura K, Kaido M, Shimmura S, Tsubota K.
Quote: The mechanism of flap adhesion immediately after surgery is strongly affected by the pump function. In the long term, flap adhesion is more dependent on the epithelium. Pathologic studies of rabbit eyes reveal epithelial hyperplasia at the flap edge.5, 6 Clinically, there have been reports of flap dislocation; however, these cases had evidence of injuries.7, 8 During LASIK enhancement procedures, the edge of the flap is observed to be tightly adhered to the epithelium. Once this tight junction is compromised, the flap can be easily peeled, which underscores the importance of the endothelial pump even in the long term following LASIK.
High Road Ethics for a High-Tech Era
Feature By Miriam Karmel, Contributing Writer
Any physician in practice today can be confronted with a challenging ethical question. But the new technologies of cataract and refractive surgey may present especially complicated—and potentially rewarding—situation.
The dissatisfied patient is nothing new. But last April, following a recent uptick in complaints from angry and disappointed patients, the Academy’s Ethics Committee issued an alert urging doctors to be more mindful of their ethical obligations.
The alert, which is posted here, addressed complaints from patients claiming they hadn’t been adequately informed of the potential visual side effects associated with multifocal or accommodating intraocular lenses. “There’s a perception that experienced cataract surgeons are not increasing their attention to assessment of patient need, and to the learning curve,” said Charles M. Zacks, MD. “That’s resulting in more unhappy refractive patients than ever.” Dr. Zacks, who chairs the Ethics Committee and practices cornea medicine in Portland, Maine, called this “a very big problem. Particularly if patients feel they weren’t adequately informed.”
The prospect for ethical challenges may be especially relevant for the new, high-tech IOLs, but the principles they invoke—informed consent, primacy of the patient’s interest and respect for the learning curve—apply whenever a physician tries incorporating new procedures or technology into clinical practice.
“There’s a lot of new technology in most of the subspecialty fields in ophthalmology,” said Richard L. Abbott, MD, professor of ophthalmology at the University of California, San Francisco. “The challenge, ethically, is which technology to embrace? Where do you draw the line between offering the newest technology over a long-standing proven device or procedure? The bottom line should always be what is in the best interest of your patient.”
More Options Mean More Chair Time
When monofocal IOLs were the only choice, the nature of pseudophakic vision was relatively easy to explain. Now patients have multiple options, which require more discussion and tougher decisions. It’s the surgeon’s responsibility, said Dr. Zacks, to give the patient a realistic impression of what these lenses will and won’t do. Will distance or near vision be important to the patient? How will the patient feel about wearing reading glasses? “Everything’s a trade-off in optics. These lenses can compromise contrast sensitivity and other optical qualities in exchange for multifocality. The patient needs to know the advantages and disadvantages of the lens they’re going to get, in unvarnished terms. Fitting the available technology to the patient is really the goal.
”“If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”
Preop hopes meet postop reality. Patients whose expectations aren’t met can be extremely unhappy, said William W. Culbertson, MD, professor of ophthalmology at Bascom Palmer Eye Institute and a member of the Ethics Committee. Take the case of the myopic engineer, a woman in her 50s, who’d been accustomed to taking off her glasses to read the fine print on drawings. Following surgery, her reading varied under different lighting conditions, she could no longer read closely without glasses, and halos put an end to her night driving, said Dr. Culbertson, who saw her by referral. The woman claimed she didn’t know she had multifocal lenses until an optometrist examined her eyes. Perhaps her ophthalmologist had told her, but postoperatively she didn’t recall being told anything about multifocal lenses or their potential optical side effects, Dr. Culbertson said. The point is, she hadn’t been adequately informed of the drawbacks.
“I’m not putting down these lenses,” added Dr. Culbertson, who uses them. “They’re very helpful. But the patient needs to clearly know what’s going on, which takes more chair time,” he said. “You can partially off-load it to brochures and videos and patient counselors. In the end, it comes down to the doctor helping the patient make the best choice and answering all the patient’s questions. If doctors aren’t willing to put time in both before surgery, in terms of education and evaluation, and after, in terms of management to optimize the final result, they shouldn’t be using these lenses.”
New Isn’t Always “Best”
And yet some doctors do regard every patient as a candidate for the new lenses, said Marian S. Macsai, MD, professor and vice chairwoman of ophthalmology, Northwestern University, and chief of ophthalmology, Evanston Northwestern Health Care. She senses “an urgency in the air” to put multifocal lenses into as many patients as possible, as well as an attitude that the cataract surgeon who isn’t using these lenses is behind the times.
Recently, Dr. Macsai heard a doctor say that his goal is “100 percent conversion.” In other words, he would like every one of his patients who comes in with a cataract to walk out with a premium lens upgrade. But these lenses are not for everybody, Dr. Macsai said. There’s no reason, for example, for a doctor to urge multifocal IOLs in a person who doesn’t mind wearing glasses, or for a person whose livelihood depends on driving at night. Similarly, she said, the lenses aren’t suitable for patients who are impaired by other disease, such as age-related macular degneration or diabetic retinopathy, since they lack the visual potential to benefit from multifocals.
When there’s not even a cataract. Then there’s the matter of clear lens exchange. “I’m not sure we should be whipping out lenses of normal people because the technology exists and we want to make money. That’s just not a good enough reason,” Dr. Macsai said. Having said that, she acknowledged a place for them in the armamentarium. “For some patients they’re fabulous. It’s just, ‘Slow down everybody! Make sure we’re doing what’s best for our patients and not our pocketbooks.’”
Physician comfort with the technology. The new technology or device should also be what’s best for the physician in terms of philosophy and comfort level with adopting new procedures. Some physicians adopt new practices more readily than others. “There’s a tension between trying new things, pushing the envelope and what’s safe for the patient,” said Ruth D. Williams, MD, a glaucoma specialist in private practice in Wheaton, Ill. Dr. Williams added that glaucoma specialists, for example, are always trying to think of new ways to do filtering surgery. “When you have a patient in front of you, the question is, ‘We have a gold standard in trabeculectomy, and a gold standard in putting in valves. What are the parameters that make it reasonable to try something else that’s not as proven?’”
In part, the answer rests with personality as well as with responsibility. “Some [physicians] always want to try new things, others want the tried, true and proven. People are different. We need both. Our community needs both,” said Dr. Williams.
Dr. Abbott agrees that some ophthalmologists are greater risk takers than others. “Does that mean they’re doing a better job for their patients? I don’t know. Everybody needs to look within and determine what is his or her own personal comfort level,” he said. “In all cases, however, the bottom line is patient-centered.”
ETHICAL PROBLEM, OR LEGAL?
Results of Lasik not always clear - Many angry patients suffer silently with visual defects
By Robert Mitchum | Tribune staff reporter August 21, 2007
Millions of people are estimated to undergo the Lasik procedure each year in the United States at academic clinics, private practices and corporate centers. While the vast majority experience no long-term complications of the surgery, a small percentage find themselves with permanent visual defects that are difficult to treat and hard to live with.
Some of these patients respond in anger; a browse of the Internet will turn up several venomous sites calling for litigation against Lasik surgeons, a horror story from comedian Kathy Griffin and even calls for a ban of the procedure itself. Other patients suffering from post-surgical complications languish in silence, unaware of their options for treatment.
Barbara Berney of Rockford was one of these patients, suffering from a long list of complications after her Lasik surgery in 2001: dry eye, night blindness, dimmed vision and a suite of aberrations, including ghosting, halos and starbursts.
"If you made a list of complications, I'd probably have 70 percent of them," Berney said. "How I can stay sane, I don't know."
After a second surgery did not significantly improve her vision, and after an unsuccessful legal action against her surgeon, Berney decided to start an organization for people in her situation: the Vision Surgery Rehabilitation Network.
Group offers support
The VSRN connects people struggling with Lasik complications with ophthalmologists and optometrists experienced in treating such cases. It also offers a measure of emotional support for people struggling with visual defects.
"I've had a couple people commit suicide, who could not imagine living the rest of their lives seeing the way they see," Berney said.
"You cannot underestimate what loss of vision can do to you, and it's very difficult to get family members and co-workers to understand just how difficult it is. It's like trying to explain the color of milk to someone who's blind."
Lasik surgery involves opening a flap in the surface of the eye and shaving down the cornea with a laser, which can correct both nearsightedness and farsightedness as well as conditions such as astigmatism. While new technologies have improved some of the more troublesome steps in this procedure, some complications remain.
The most serious, according to Dr. Michael Rosenberg, ophthalmologist at Northwestern Memorial Hospital, are infections and ectasia, a bulging caused by destabilization of the cornea. In extreme cases, these complications may be treated with a corneal transplant; however, their occurrence is very rare.
READ THE FULL STORY
Eye surgery leaves many with problems
Of millions of patients, more than a few have serious, lasting complications
Sabine Vollmer, Staff Writer
Millions of Americans have undergone laser eye surgery to correct bad vision, and along with the procedure's popularity something else is coming into focus: its hazards.
Advertising stresses the surgery's safety, and most procedures are successful. Tiger Woods, who relies on keen eyesight as the world's best golfer, pitches it as a quick and painless way to restore sharp vision. Even the U.S. Air Force, long skeptical of the surgery, changed its policy in May to let people who had LASIK apply for pilot training.
But every year thousands of Americans who undergo LASIK are left with chronic pain, dryness of the eyes, distorted night vision and even blindness, according to Food and Drug Administration statistics.
LASIK -- which stands for laser-assisted in-situ keratomileusis -- uses lasers to cut and reshape the cornea. It can improve eyesight without complications, but equipment flaws, a surgeon's error or a failure to screen out patients whose eyes are ill-suited for the treatment can cause the operation to go awry.
The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, estimates that only 2 percent to 3 percent of the more than 1 million LASIK surgeries each year are unsuccessful. But Food and Drug Administration records of clinical studies show that six months after the surgery, up to 28 percent of patients complained of eye dryness, up to 16 percent had blurry vision and up to 18 percent had difficulty driving at night.
The Triangle, home to two medical schools, is a hot spot for LASIK; 11 eye centers will perform LASIK on about 8,000 patients this year, according to market research.
One of the leaders is Duke Eye Center, whose LASIK surgeons are among the best-trained and best-equipped in the field. But even surgery at Duke's level has damaged a few patients' eyes beyond repair.
One of those patients is Matthew Kotsovolos, 38, of Raleigh. He was the Duke Eye Center's head of finances and received the surgery for free June 8, 2006. It gave him 20-20 vision but left him with intensely dry eyes and excruciating facial pain. He wakes up with sore eyes every morning, wears special goggles to preserve eye moisture and wonders when the pain in his face will kick in.
"I traded in my glasses for permanent head pain, eye pain and these things," Kotsovolos said, pointing to the goggles.
Nine months after his surgery, Kotsovolos quit his job at the Duke Eye Center, took a 25 percent pay cut and started work as business manager in the Duke University Medical Center's gastroenterology division. He is organizing a support group for LASIK patients with complications.
"It may help inform people that this is a surgery with real risks that are understated by LASIK surgeons," Kotsovolos said.
Alan Carlson, head of the Duke Eye Center, said his experience with LASIK is that complications are rare. Carlson, who did not operate on Kotsovolos, said only a handful of the roughly 6,000 LASIK patients he has treated at Duke since 1996 ended up with problems. The eye center does very well in patient satisfaction surveys, he said.
But Carlson acknowledged that the procedure can cause serious complications.
"It's imperfect surgery in an imperfect world," he said.
How many LASIK patients develop post-surgery complications is obscured by a lack of regulation and reporting. Because health insurers don't pay for LASIK, they generally don't track complications. The FDA doesn't require reports from doctors, and regulatory enforcement has been largely limited to recalling malfunctioning lasers.
Evidence of problems is accumulating. Some of the strongest is the growing market for contact lenses designed for people who have undergone LASIK and still have vision problems, some seeing worse than before the surgery. One of the leading post-LASIK lens makers is MedLens Innovations, a Front Royal, Va., company founded in 2000.
Robert Breece, an optometrist and MedLens' president, said his company provides hard contacts to more than 2,500 post-LASIK patients annually and business is increasing about 10 percent every year. Breece said his company serves more than 200 people per year who have been seriously disabled by the surgery.
"I don't get to talk to happy LASIK patients," he said.
By the end of the year, SynergEyes of Carlsbad, Calif., plans to bring to market the first line of contact lenses designed specially for laser eye surgery patients with complications who cannot tolerate hard lenses.
A trial version of the SynergEyes contact lenses have given Paula Cofer, 49, of Tampa, Fla., some relief from dry, itchy eyes and night vision so distorted that she sees up to eight moons.
The specially fitted contacts cost $300 every six months, Cofer said. Contact lenses solution, sterile saline solution, artificial tears and lenses rewetting drops run another $150 to $160 per month.
"Life was very simple then," she said about the 30 years she wore glasses. "Now, it's very complicated."
Limitations of LASIK
Patients with complications are starting to fight back on the Internet and through support groups. Medical research in the past three years has come up with insights about LASIK worrisome enough that some eye surgeons have begun to ease away from the procedure.
"We've learned the limitations of LASIK," said Dr. Stephen Pflugfelder, professor of ophthalmology at Baylor College of Medicine in Houston.
An expert in laser eye surgery for more than 15 years, Pflugfelder is increasingly falling back on an older, less invasive procedure known as photorefractive keratectomy, or PRK, which involves only the surface of the eye.
In the past three years, the number of LASIK procedures at Baylor has dropped from about 70 percent to about 50 percent of all laser eye surgeries.
At Duke, LASIK makes up about 80 percent of all laser eye surgeries. Carlson, head of the Duke Eye Center, is comfortable with that.
"Dry eye hasn't been a big problem," he said.
The university buys the most sophisticated lasers on the market, he said. Patients are screened for risk factors and informed of what they can and cannot expect from LASIK. A surgeon might even do the surgery on one eye at a time.
Those precautions did not prevent Lauranell Burch, a former Duke medical researcher, from suffering a serious complications after undergoing LASIK at the Duke Eye Center.
Burch 47, said that since the surgery March 31, 2004, her eyes sting and burn all the time, her eye tissue is wrinkled like a Ruffles potato chip and her night vision is distorted.
"[The damage] is noticeable and on the front of your mind all your waking hours," Burch said. "There's no escape."
In the winter, she takes an anti-anxiety pill about 15 minutes before she drives home in the dark from her job in Research Triangle Park. She compares the distortions she sees at night, also known as star bursts, to explosions of light without a bang.
Burch cut short her follow-up treatment at Duke, became an avid patients' advocate and started to take on LASIK surgeons on the Internet.
Risks of high volume
All LASIK surgeons make an effort to screen patients, and many turn away patients with obvious risk factors.
But LASIK is essentially a buyer-beware procedure.
In choosing a surgeon, patients are usually advised to go with doctors who perform the procedure most frequently. But with LASIK, That advice can be risky.
Dr. Christopher Fleming, a Cary ophthalmologist and former president of the N.C. Society of Eye Physicians and Surgeons, said patients should beware of LASIK surgeons who perform a high volume of operations.
Surgeons who do 10 or 15 LASIK operations a week tend to contract with optometrists who refer patients, Fleming said. In return, the optometrists, who are not medical doctors, screen the patients and do the follow-up care. Some also receive referral fees.
The emphasis on volume, Fleming said, can draw patients into surgery whose eyes are not suited to LASIK. Patients also end up getting follow-up care from optometrists instead of their surgeons.
Fleming performs no more than one or two dozen LASIK surgeries a year and personally screens patients and does the follow-up care. As a result, his patients rarely have complications, he said.
"When you're high-volume and relinquish part of the care to non-physicians," Fleming said, "you don't have time to be thorough. That can lead to problems."
What deters lawsuits
How many North Carolinians have problems after LASIK is not a public record. Patient complaints filed with the N.C. Medical Board are confidential, and the data are not organized by medical procedure.
Only a few complaints become lawsuits, said Bill Faison, a well-known medical malpractice lawyer in Durham who has represented one LASIK patient in court in the past three years.
What foils most attempts to sue for damages, Faison said, are the costs to mount a legal challenge. Also, carefully worded patient consent forms spell out the risks of the surgery and often require patients to first try to work out their differences with the LASIK center.
"Short of the [LASIK surgeon] being stupid, if it's just a bad outcome, there's nothing to recover," Faison said.
The procedure is safe and effective for many, said Dr. Brad Randleman, a laser eye surgeon at Emory University in Atlanta who has done LASIK on about 1,000 patients over the past five years.
Post-surgical complications such as dry eyes and vision distortions often subside after a few weeks.
"I had nothing but a great experience," said Jim Branch, 55, a Raleigh real estate developer who had LASIK at Duke about five years ago.
Medical research has found that cutting the cornea permanently weakens it. The severed nerves need years to recover and might misfire pain signals. But those findings have not been conclusively linked to lingering complications from LASIK, said Dr. William Bourne, an ophthalmology professor and LASIK surgeon at the Mayo Clinic in Rochester, Minn.
"I don't think we've proven what it is," Bourne said.
A better understanding of what causes the complications is essential to screen patients more effectively and eliminate those at risk, he said.
Kotsovolos said he was considered a good candidate for LASIK. His Duke LASIK surgeon blamed part of his problems on an eye inflammation unrelated to the procedure. Another eye specialist has since diagnosed Kotsovolos with a severe dysfunction of the glands lining the eyelids. The condition is considered a red flag when it is found during screening for LASIK.
Charles Hybarger, a building contractor who lives near Chattanooga, Tenn., changed his mind about LASIK after his wife, Kim, a 44-year-old trained nurse, had an unsuccessful procedure Dec. 21 and the complications triggered a deep depression.
Hybarger wonders whether his wife's rheumatoid arthritis should have eliminated her from having LASIK. Laser eye surgery should not be done on patients with auto-immune diseases.
"I wouldn't let any doctor cut on me unless it's life or death," Hybarger said. "I just wear my glasses and be happy with it."
News researcher Denise Jones contributed to this report.
Industry's Influence on Medicine
Cataract & Refractive Surgery Today
Michael P. Graham, MD
Quote: ...the leaders in our field have become so corrupted by accepting large consulting fees from industry that they are no longer unbiased sources of information.
Quote: It is a sad step backward for ophthalmology when, due to the corrupting influence of corporate consulting money, I feel anecdotal evidence is more reliable than clinical studies.
Quote: I would implore our leaders to do something about this sad situation. Please stop relying more and more on consulting fees for your income. You may not realize it or want to admit it, but it is having a huge effect on how you conduct your studies and what you say at meetings. It is also having a detrimental effect on our profession, because we now have nowhere to go to get unbiased medical information except to rely on our anecdotal experience. Please stop being drug representatives and return to being doctors. After all, that is why we all went to medical school in the first place.
Most "leaders" in the LASIK industry are paid consultants to one of the laser manufacturers. Here's just a small sample of surgeons who are paid consultants:
The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interesthttp://www.journals.uchicago.edu/JLS/journal/issues/v34n1/340105/340105.web.pdf
Daylian M. Cain, George Loewenstein, and Don A. Moore
ABSTRACT: Conflicts of interest can lead experts to give biased and corrupt advice. Although disclosure is often proposed as a potential solution to these problems, we show that it can have perverse effects. First, people generally do not discount advice from biased advisors as much as they should, even when advisors’ conflicts of interest are disclosed. Second, disclosure can increase the bias in advice because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further. As a result, disclosure may fail to solve the problems created by conflicts of interest and may sometimes even make matters worse.
Quote: Yet physicians are still influenced by gifts or incentives of minimal value.2 So the take-home message is clear. Disclosure may embolden speakers to introduce even more bias than they would otherwise, and listeners may not be able to discount biased information as much as they’d like.
Jean-Luc Seegmuller: "I don’t think ophthalmologists should admit their mistakes. It’s too dangerous, and I have seen several too-honest colleagues who were in a very bad situation afterwards, and we have tried our best to take them outside but it was very, very difficult.Admit the mistakes? No. Describe the facts and say ‘I have done that,’ but not say it was good or bad, but rather I have done that and this is the consequence and so it was like that, or the complication is like that. It’s too dangerous to say that I have done this and now you are in a bad situation."
5 Questions with Lucio Buratto, MD
Cataract and Refractive Surgery Today
"What is the biggest obstacle facing refractive surgery and refractive surgeons today?
In the past, we made similar mistakes around the world. We excited our patients about the possibility of extremely good results, and we treated too many patients (some nonexcellent indications); I would say we treated all (or at least the overall majority) of the patients who entered our respective practices. Not all of the patients we treated were really good candidates for surgery, and not all of them received the treatment with the best machines and technology available. Unfortunately, because we had some bad worldwide results, we received bad publicity in the media.
Therefore, patients may now be skeptical about refractive surgery. I know for sure that when I have the right patient, I can give them excellent results. Patients do not always trust the surgery or the surgeon anymore, because we promised too much in the past.
What advice do you have for new surgeons, with regard to managing their patients' expectations and outcomes?
I would tell them to do less business and to take care of the patients they currently have. Unfortunately for many refractive surgeons, when they see a patient, they see dollars in their eyes and not a professional opportunity to improve quality of vision and life for their patient. It is not the same way for a cataract surgeon or a retina specialist, but it is a typical approach of a refractive surgeon. They should focus more on their patients and less on their incomes.
Admit Mistakes, keep good records to protect against malpractice suits
OSN SuperSite Top Story 8/16/2006
BOSTON — Keeping detailed patient charts, documenting informed consent and accepting responsibility for errors when they occur can help refractive surgeons avoid costly malpractice suits, according to two attorneys speaking here.
"Patients lose trust with their doctor if their doctor minimizes or ignores their problems. Physicians should be aware of this, because if patients lose trust, they will look for other doctors or find their way to a plaintiff lawyer," said Greg K. Zeuthen, a plaintiff attorney.
Mr. Zeuthen and Kevin E. Oliver, a defense attorney, discussed the current medicolegal climate in refractive surgery in two keynote lectures at American Society of Cataract and Refractive Surgery Summer Refractive Congress. They outlined LASIK cases they have handled in court and possible approaches surgeons could employ to avoid litigation.
Mr. Oliver said he tells doctors to imagine a hypothetical situation in which all their charts have court exhibit stickers on them. He then asks them to carefully consider whether those charts are well-documented and adequately clear to be used in a defense or a prosecution.
"You need to chart everything," Mr. Oliver said.
Mr. Zeuthen noted that draconian documentation is the key to minimizing the risk of legal action. Should a case go to trial, it is also important for mounting a defense.
"Paranoia is not bad at all," Mr. Zeuthen said. "It's just a higher state of awareness. If you practice medicine with a higher state of awareness, you're going to avoid more lawsuits."
Both lawyers noted that surgeons should be honest when dealing with refractive surgery mistakes or errors. Most refractive surgery patients are highly educated individuals who understand the legal system and will sue if not treated appropriately, they said.
"It's how a bad outcome is dealt with in your office that determines whether a patient will go to another doctor of to a plaintiff's lawyer," Mr. Zeuthen said.
Quote: When it comes to dealing with the unhappy patient, the temptation may be for the practitioner to deny that a result is less than optimal or to avoid the patient altogether.
Quote: Maloney spends a half-day a week just dealing with patients with LASIK complications who have been sent to him on referral. "It's difficult, because generally they don't get to me until there has been some fracture in the relationship with the surgeon," he said. If he can, Maloney reassures the patient that the surgeon didn't make any mistakes.
Quote: But what about the patient who is the victim of a medical error?
Most risk management experts, including those at OMIC (Ophthalmic Mutual Insurance Company), recommend immediate and full disclosure of the error, as soon as the patient is able to understand.1 What is not as widely practiced is a heartfelt personal apology to the patient by the physician. An editorial by the chancellor of the University of Massachusetts Medical School, Aaron Lazare, MD, is well worth reading.2 Considerable literature has now accumulated showing that, where it is practiced, disclosure of errors and an apology to the patient has actually reduced the number and cost of malpractice claims. According to Dr. Lazare, there are four parts to an effective apology: acknowledgement of the offense (who, what, where); an explanation of the circumstances bearing on the offense (why); an expression of remorse, shame, humility and a commitment not to repeat the offense; and finally reparation (which could include early scheduling for next appointment, cancellation of the bill, etc.). Not all four parts need be present in every case for an apology to be effective, but an ineffective apology can usually be traced to omission of at least one part.
How do apologies heal? To understand this, it is helpful to examine how a patient feels when he or she learns of a medical error. They often express humiliation, “I was treated like I was on an assembly line,” powerlessness, lack of validation of emotions, the feeling that they were somehow at fault, and, not surprisingly, concern that the same thing could happen to someone else. The longer those feelings fester, the more difficult they are to mitigate through apology. But a prompt and proper apology can make the patient feel cared about by the physician, whose self-humbling has leveled the emotional field between them. Showing a patient how their experience will lead to changes in procedure to avoid recurrence restores their sense of power. Validation of the reasonableness of the patient’s feelings about the error is also helpful in reducing their amplitude.