Denver, CO (LASIK Newswire) August 24, 2008 — On August 20, 2008, plaintiffs, Jenna Reed and Rian Reed, filed their complaint in the United States District Court, District of Colorado, seeking damages against Alcon for strict liability, negligence, breach of warranty, misrepresentation, and violation of the Colorado Consumer Protection Act. Case Number 1:08-cv-01759-EWN Reed et al v. Alcon Laboratories, Inc. et al Complaint.

LASIK eye surgery is among the most prevalent forms of elective surgery performed in the United States. It is estimated that it is performed on approximately one million eyes per year. The LASIK industry generally, and defendants in particular, profess that the surgical laser systems used to perform the surgery are safe. However, on February 21, 2007, the United States Food and Drug Administration recalled defendants’ excimer surgical laser system, known as the LADAR6000 Excimer Laser (the ALADAR6000) due to reports that the LADAR6000’s CustomCornea Myopia and CustomCornea Myopia with Astigmatism algorithm procedures were causing Acentral islands in patients.

Unfortunately for the plaintiff Jenna Reed, a 33 year old wife and mother of two, who resides in Longmont, Colorado, the FDA Recall came too late. She was one of approximately 20 patients who were injured by the defective LADAR6000, which was used by her LASIK surgeon at Insight LASIK, in Layfayette, Colorado.

On September 22, 2006, Mrs. Reed’s doctor performed LASIK surgery on her, and programmed the LADAR6000 to perform CustomCornea Myopia with Astigmatism on Jenna Reed.

Predictably, Jenna Reed has developed Acentral islands, which are a laser created defect in her eyes caused by the laser’s uneven application of energy to her corneas. As a consequence of resultant peaks and valleys in her corneas, Jenna Reed is left with a permanent visual disability marked by problems with her vision, which include, without limitation, blurring, ghosting, double vision, photosensitivity, poor night vision, and ocular headaches.

Defendants have offered to send Jenna Reed, and numerous other patients injured by its defective LADAR6000, to Texas for purported corrective surgery. However, Jenna Reed’s eye care professionals at InSight (who are not the subject of this lawsuit) have advised her that there is no certainty that any further surgery can cure or correct her injuries.

The plaintiffs are represented by Carrie Frank of Klein | Frank, P.C., in Boulder, Colorado and Todd J. Krouner, from Chappaqua, New York. Mr. Krouner and Ms. Frank have also filed suit on behalf of another patient, Melanie Wheeler, of InSight who was also injured as a result of the defective LADAR6000. Klein | Frank, P.C. is a nationally recognized firm that handles cases involving defective products, personal injury and defective drugs throughout the United States.

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Contact Information
Carrie Frank
Klein | Frank, P.C.
http://www.lawcolorado.net
303-448-8884
 

Source: FDA Maude Database Report

Companies that manufacture lasers for use in LASIK surgery are required by the FDA to provide Patient Information Booklets to LASIK surgeons.  In turn, LASIK surgeons are required to provide the booklets to prospective patients prior to surgery. Patient Infomation Booklets provide warnings and other information for patients to consider before consenting to undergo LASIK.

Below are two examples of the FDA mandate regarding Patient Information Booklets.  The first example is found in an FDA Approval Order for the VISX laser, and the second is found in the VISX Physician Instruction Booklet.

Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet (as described in your final submission to this PMA supplement). Link

All patients must be given the opportunity to read and understand the Patient Information Booklet and to have all their questions answered to their satisfaction before giving consent for Laser Assisted In Situ Keratomileusis (LASIK). Link 

LASIK surgeons also fail to comply with mandatory reporting of complications and adverse events, as evidenced by researching the FDA’s Maude database.  See related story.

Obviously, the LASIK industry has done a poor job of policing itself.  And the FDA has done an equally poor job policing the use of LASIK devices. As a result, many patients have suffered serious injury and loss of quality of life.   

The psychosocial and health consequences of ocular conditions that lead to visual impairment (VI) are broad and include impaired activities of daily living,  social isolation, cognitive impairment, impaired functional status and functional decline, increased dependency on others, increased risk of motor vehicle crashes, falls and fractures, poor self-rated health, and depression. Increased mortality risks also have been noted in adults with VI and disabling eye disease… Up to two-thirds of people who commit suicide have some type of physician contact in their last month, and physician education is effective in reducing suicide rates. Our results suggest older adults and those with nonocular health conditions, poor self-rated health, and reported VI are at increased suicide risk. Eye care professionals should be aware of the potential increased risk of suicide for patients with VI, especially those in poor health, and provide appropriate referrals for these patients… In summary, we observed that reported VI increased suicide risk, particularly indirectly via reported health status and health conditions.

Earlier this year in response to media reports of depression and suicide following LASIK, LASIK industry insiders denied any connection.

Dr. Richard Lindstrom, “The premise of your Feb. 3 article ‘Some link depression, failed LASIK’ was based upon incomplete, unpublished and anecdotal research and did a disservice to the millions of Americans who elect to undergo vision correction surgery each year. It is irresponsible to draw a conclusion between LASIK and suicide. There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.” Source

Dr. Steven C. Schallhorn, “There’s no cause and effect.”  Source

These statements by LASIK industry leaders are perplexing, given the contradictory evidence published in the body of scientific literature.  It is widely reported that visual impairment has an adverse effect on quality of life, which may lead to depression and thoughts of suicide. 

At the April 25, 2008 FDA hearing on post-LASIK issues, several speakers gave compelling testimony of the link between bad outcomes from LASIK and depression and suicide.  LASIK industry representatives in attendance appeared unmoved. 

——————————————————

Byron L. Lam; Sharon L. Christ; David J. Lee; D. Diane Zheng; Kristopher L. Arheart. Reported Visual Impairment and Risk of Suicide: The 1986-1996 National Health Interview Surveys. Arch Ophthalmol. 2008;126(7):975-980.

 July 15, 2008

Corneal ectasia; thousands of late onset complications of LASIK likely
LASIK surgeons fail to comply with FDA reporting requirement

After recklessly performing millions of LASIK surgeries over the past decade with little to no policing of its poor surgical practices and deceptive advertising, the LASIK industry is feeling the pinch.  LASIK volumes have plummeted after a flurry of bad press and public outcry of widespread problems with LASIK.  But this doesn’t help the patients who have been needlessly harmed by an unnecessary, irreversible surgery. 

When a patient suffers a complication of LASIK, the surgeon is required to file a MedWatch report with the FDA.  In a press release earlier this year, the LASIK industry stated that only 140 reports had been filed with the FDA “relating to LASIK dissatisfaction” between 1998 and 2006. In issuing this statement, the LASIK industry admitted that LASIK surgeons routinely fail to comply with FDA reporting requirements.  In fact, it appears that most LASIK surgeons have never filed a single MedWatch report.  

The LASIK industry received Food and Drug Administration (FDA) approval to perform a destructive surgery on healthy eyes based on sloppy science and insufficient, short followup data.  LASIK causes chronic dry eyes and poor night vision in approximately 20% of patients, according to a review of FDA clinical trials.  These “symptoms” were not disclosed to prospective patients, even though they can be permanent and life-altering.

But one complication of LASIK has the industry concerned because public awareness of the sight-threatening complication, corneal ectasia, could further tarnish the image of LASIK.  Ectasia is a progressive forward bulging of the cornea, which requires corneal transplantation in most cases.  Ectasia strikes when the cornea is too weak after LASIK to withstand the stress of the intraocular pressure of the eye.  Medical studies show significant, permanent weakening of the cornea after LASIK in all eyes, which may lead to ectasia years after surgery. 

The incidence of ectasia is estimated to be approximately 1 in 2,500 but this number could be an underestimate due to underreporting and lack of long-term followup after LASIK.  Approximately 8 million people have undergone LASIK in the United States, likely resulting in thousands of unreported cases of post-LASIK ectasia. 

Failure of the FDA to order long-term followup of LASIK patients (post-market surveillance) and enforce MedWatch reporting of LASIK complications is to blame for lack of public awareness of the potentially blinding complication of post-LASIK ectasia.  But patient groups are watching, and they want the FDA to know that they will hold the Agency accountable.     

FDA HEARING PRESENTATION OF LAURANELL H. BURCH

I appreciate the opportunity to speak at this FDA hearing on post-market LASIK issues. My name is Lauranell Burch. I have a Ph.D. in Molecular Biology and Genetics and have been a medical researcher for over 20 years. I am trained to design, conduct, and review medical research studies.

We are all aware of recent media attempts by the LASIK industry to reframe the discussion of these hearings around post-LASIK satisfaction and quality of life issues. The public should be made aware that the proposed task force to examine post-LASIK quality of life issues is dominated by individuals who have conflicts of interest. One of these individuals, Dr. Kerry Solomon, was quoted this week by ABC news regarding this meeting saying: “This is not about safety and effectiveness of LASIK surgery at all,”… If there were no serious concerns about the safety and effectiveness of LASIK - we wouldn’t be here today. What is most important for us all to consider now is the growing body of evidence accumulating in peer-reviewed Ophthalmology journals that indicate that LASIK is a harmful procedure.

Despite claims made by surgeons and the industry about ‘patient satisfaction’, today’s happy 20/20 LASIK patients are often today’s dangerous drivers on our highways at night due to LASIK-induced loss of contrast sensitivity, and may ultimately experience debilitating late-onset complications of LASIK.

Patients who report that they are currently happy with the LASIK procedure likely have no idea of the nature and extent of damage they incurred during the LASIK procedure and the consequences of this damage for their future ocular health and vision. I believe that no patient would want this surgery if they fully understood its consequences.

Here is a short list of permanent adverse effects of LASIK eye surgery:

1. The flap never heals – it just seals a bit around the edges like a Tupperware lid leaving patients who have had LASIK susceptible to traumatic flap injury for life.
2. LASIK separates the stronger anterior cornea, leaving only the weaker posterior cornea to support the intraocular pressure of the eye. This can lead to corneal ectasia and corneal failure months or years after surgery.
3. LASIK causes permanent pathological changes in all corneas. According to an Emory University study that examined post-mortem LASIK corneas, “A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas.” Some examples include deranged and disorded collagen fibers, granules under the flap, and epithelial ingrowth under the flap.
4. There is no evidence that corneal nerves ever fully regenerate to their normal patterns and density after LASIK.
5. LASIK complicates future cataract surgery.
6. LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.
7. Perhaps the gravest of all adverse effects of LASIK was reported recently by Mayo clinic researchers in a study which indicates that patients undergoing laser corneal refractive surgeries lose keratocyte (or corneal stromal cell) density at higher rates even years after surgery. Apparently, excimer laser ablation of corneal stroma results in progressive cell loss in the cornea.

In the peer discussion following this study, LASIK surgeon Dr. Roger F. Steinert commented, and I quote him: “One can speculate that this loss might lead to corneal ectasia.”

Clearly, patient satisfaction surveys are no substitute for objective quantitative testing, particularly when the technology for performing objective tests is widely available.

I ask that the FDA abandon the proposed quality of life study in favor of a study which objectively and quantitatively measures aspects of post-LASIK dry eye disease and post-LASIK visual quality. These studies can be performed on existing patient populations with unoperated eyes as controls. Withdrawal of FDA approval for the LASIK procedure should take place immediately pending the outcome of these studies. Only then will the FDA be able to achieve evidence-based policy about corneal refractive surgery devices, and only then will the public receive the benefits of evidence-based medicine.

Dockets Management Branch
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD 20852

Citizen Petition
The undersigned submits this petition to:
1) ban the use of all refractive surgery lasers for LASIK surgery due to substantial deception in the labeling and an unreasonable and substantial risk of injury, and
2) acknowledge and enforce remedy for the misbranding of lasers used for LASIK (false and misleading labeling) due to failure to properly report adverse events and complications. 

The authority for the first action is under U.S. Code Title 21, Section 516 [21 USC 360f] of the Federal Food, Drug, and Cosmetic Act, Banned Devices.  Authority for the second action is under U.S. Code Title 21, Section 502 [21 USC 352a] of the Federal Food, Drug, and Cosmetic Act, Misbranded drugs and devices - False or misleading label. 

Factual Grounds
In the FDA clinical trials of lasers for LASIK, the devices failed to meet the Agency’s safety requirements.  The guidance document dated 9/5/1997 titled Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers” Draft Document (exhibit A)  states that less than one percent of eyes may experience adverse events.  A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved from 1998 through 2004 (exhibit B) found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes.  These complications were deceptively reported as “symptoms”; however, they should have been reported as adverse events.  The risk of injury from the medical devices used to perform LASIK is unreasonable and substantial.  The purported benefits of LASIK (reduced dependence on glasses or contact lenses) do not outweigh the risks.  LASIK surgery does not meet any medical need that cannot be met with safer alternatives, such as glasses or contact lenses.

LASIK devices appear to meet the efficacy standards for approval; and most patients report satisfaction with the visual outcome even in the presence of complications such as dry eyes and night vision impairment. It should be noted, however, that of the 14 FDA approvals for LASIK, no study of safety and effectiveness of LASIK reported adverse events in less than one percent of eyes as required by FDA safety requirements for approval.

Environmental Impact
This petition qualifies for categorical exclusion under 25.30 - 34 of this chapter from the requirement of an environmental impact assessment. 

Certification
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which are unfavorable to the petition.
______________________________    
Name of petitioner:  Lauranell H. Burch

Exhibit A: Checklist of information usually submitted in an Investigational Device Exemption (IDE) application for refractive surgery lasers.

Exhibit B: Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events.  In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.  

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that “Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.” Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?”

Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR…does not provide timely and usable data to staff or other system users…[and]…has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?  

Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA’s intention to call a Special Hearing for LASIK post-market issues.  In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.

Not only did the FDA approve unsafe devices for LASIK, the Agency also failed to enforce reporting of adverse events.  When a patient experiences a bad outcome from LASIK, the physician should notify the FDA by filing a MedWatch report.  The medical literature contains hundreds of case reports of serious complications after LASIK, and thousands of medical studies of LASIK showing frequently occuring complications, yet the FDA recently announced that only 140 reports of adverse events after LASIK have been reported through MedWatch in the past decade.  Apparently, most LASIK surgeons have never filed a single MedWatch report, even though all LASIK surgeons have patients with complications.  And patients are not informed that they may voluntarily file their own MedWatch report.  Clearly, adverse events from LASIK have been grossly underreported, and LASIK surgeons are not held accountable.  In response to complaints from patient advocates, the FDA added a link to file a MedWatch report on its LASIK website in late May, 2008.

Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850

Dear Dr. Schultz:

I was initially encouraged to see the FDA take action by convening an advisory panel on April 25, 2008 to conduct a hearing on LASIK post-market issues including the impact on a patients’ quality of life (QOL). However, I attended the hearing and found the lack of panel discussion regarding post-LASIK quality of life (QOL) issues to be disappointing. It was stated publicly before the hearing that QOL would be on the panel members’ agenda and there were several accounts from open public hearing speakers who had interacted with hundreds of patients with severe depression and suicidal ideation post-LASIK. Yet there was no discussion amongst the panel members regarding post-LASIK QOL issues.

The open public hearing speakers who discussed the potentially severe emotional toll related to post-LASIK visual disturbances and severe dry eyes included a clinical psychologist, a medical doctor, an optometrist, a father whose son took his own life and left a note detailing his emotional struggles due to his sight having been ruined by LASIK, a wife whose husband took his life last month in Tennessee and left a note stating that his post-LASIK visual disturbances and severe dry eyes were the cause, a wife of a patient who discussed two additional LASIK related suicides, and two patient advocates who have formed support groups for post-LASIK complication patients. Most of the emotional toll from LASIK adverse events was caused by night vision disturbances, loss of best correctable vision and severe chronic dry eyes.

While the FDA has announced plans to study QOL issues related to LASIK, I am concerned that the proposed study will be biased. The FDA and National Eye Institute (NEI) have announced an unprecedented partnership with industry. The American Society of Cataract and Refractive Surgeons (ASCRS) and the American Academy of Ophthalmology (AAO) plan to conduct a post-LASIK QOL study to commence by 2009. ASCRS has announced the names of three LASIK surgeons who will design and conduct the study.  These doctors have obvious financial conflicts of interest.  Also, Drs. Lindstrom and Schallhorn have publicly stated that there is no correlation between depression and post-LASIK adverse events such as visual disturbances and severe dry eyes, and therefore cannot be expected to conduct unbiased research on this issue.

I recommend the following actions be taken to protect and inform the public that the FDA is entrusted to protect.

1. Halos, glare, night-driving problems and chronic dry eyes should be reported as adverse events and not symptoms by the FDA. Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health stated the following in a National Public Radio (NPR) interview aired on May 1st, 2008; “If it’s a decrease in vision, if it’s a halo, if it’s a starburst, if it’s a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision”. In addition, at the FDA hearing on April 25th, 2008, Malvina Eydelman, MD, head of the FDA’s division of ophthalmic devices, also stated that it was her understanding that halos, glare, and night-driving problems were listed as adverse events. The statements made by the FDA are consistent and logical when describing these complications as adverse events since they can be permanent and life altering. Therefore, I anticipate that the FDA will officially accept that LASIK induced halos, glare, night-driving problems and chronic dry eyes are indeed adverse events.

2. The FDA has partnered with ASCRS LASIK surgeons who have financial conflicts of interest in the procedure. I request that any ASCRS member with financial interests in LASIK device makers be rejected by the FDA. It is imperative that proper FDA monitoring and oversight controls be put in place to avoid LASIK surgeon-biased outcomes.  I also feel that Drs. Lindstrom and Schallhorn particularly should be excluded from such studies, as they have publicly expressed their belief that there is no correlation between depression and post-LASIK adverse events such as visual disturbances and severe dry eyes. These statements have been made despite the fact that two post-LASIK suicides have occurred within the last year where patients have left suicide notes stating that they could no longer live with their post-LASIK vision disturbances and severe dry eyes.

3. The FDA should advise prospective LASIK patients that clinical depression can result secondary to LASIK complications including post-LASIK visual disturbances and severe dry eyes. In order to meet this recommendation, clinical depression should be listed as a potential side effect of LASIK in the labeling and on the FDA website.

In the interest of informing the public of the risks of LASIK, I look forward to seeing the FDA adopt the changes recommended at its upcoming meeting. 

Sincerely,

Matt Kotsovolos

SynergEyes
2232 Rutherford Road
Carlsbad, CA 92008
Ph: 877-733-2012
Fax: 877-329-2012

Contact:
Kellie Kaseburg
Vice President of Global Marketing
kkaseburg@synergeyes.com
877.SEE.2012

SynergEyes Hybrid Contact Lenses Provide a Vision Solution for Post-LASIK Patients

San Diego, CA (April 25, 2008) – SynergEyes, Inc., of Carlsbad, CA, recently launched a revolutionary hybrid contact lens designed for people who need further vision correction after undergoing refractive vision surgery.   SynergEyes® PS (post-surgical) is also designed for patients who have experienced some type of corneal trauma or suffer from certain degenerative vision conditions.
  
Every year, millions of people undergo LASIK or other types of vision correction surgery to restore vision and eliminate the need for glasses or contact lenses.  But according to the U.S. Food and Drug Administration (FDA), approximately 5 percent of LASIK patients are dissatisfied with their outcome and experience post-operative conditions like eye pain, blurred or double vision and difficulty driving at night.

Because LASIK permanently alters the shape of the eye, traditional contact lenses and glasses often cannot provide the additional vision correction needed.  This is why SynergEyes has developed a revolutionary contact lens designed specifically to address the technical challenges of restoring vision to these patients offering them consistent, predictable vision, even at night.

Approved for marketing by the FDA, SynergEyes® PS hybrid contact lenses combine two materials — a rigid gas permeable center with a soft lens outer skirt. The “hybrid” design bonds a “hard” and “soft” contact lens together resulting in a one-of-a-kind vision correction option that provides crisp, clear vision for surgically altered corneas in a comfortable, healthy contact lens.

“The SynergEyes® PS lens has proven to be a safe, effective and comfortable lens for the restoration of post-surgical vision loss,” says Dr. Edward Boshnick of Miami, Fl. “It has become my first choice lens for the treatment of patients who have lost quality vision and comfort due to refractive and corneal transplant surgery.”

Until being fit with SynergEyes® PS, Gabriel Meneses, a patient of Dr. Boshnick, had been struggling daily with post-LASIK side effects like blurry vision, ghosting and migraines after having the surgery six years ago.  His vision could not be adequately corrected with eyeglasses or other contact lenses. “Dr Boshnick gave me the opportunity to be one of the first to try the new SynergEyes® PS  lens…all I can say is what a difference!  As for vision quality, this lens has definitely offered me the best I’ve experienced so far.”

Incorporating patented HyperBond™ technology and HydrolEyes™ surface science, the SynergEyes contact lenses with FDA market clearance include SynergEyes® A for naturally occurring ametropia, targeting patients with astigmatism, current gas permeable lens wearers, and patients demanding optimized vision; the SynergEyes® KC for keratoconus, the SynergEyes® Multifocal lens for presbyopia and the SynergEyes® PS for post-surgery and post trauma refractive errors. 

# # # # #

In the past decade, several lasers have received FDA approval for use in LASIK surgery.  A report of data from FDA clinical trials for LASIK, including current technology, reveals that approximately 20% of patients report complications.¹  The report shows that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare, 19.3 percent had night-driving problems and 21 percent complained of dry eyes.  It appears that if FDA had properly classified these “symptoms” as adverse events or complications, the devices would have failed to meet safety requirements for approval.  

The FDA’s MedWatch program allows healthcare professionals and consumers to report adverse events associated with medical devices, such as those used to perform LASIK.  However, patients are not informed about the MedWatch program and there is no enforcement of reporting by physicians.  The inconsistency between the reported complication rates from LASIK clinical trials and the number of adverse events reported to the FDA through the MedWatch program clearly shows that complications from LASIK are grossly underreported.  

Reports of widespread, serious problems with LASIK prompted FDA to hold a post-market meeting on April 25, 2008 to hear patient complaints and to accept recommendations from a panel of experts.  The panel was chaired by LASIK surgeon, Dr. Jane Weiss.  In her closing remarks, Dr. Weiss blamed the problems on “some surgeons who should be doing a better job”, rather the surgery itself.  Patients felt the hearing was a sham.  

Two weeks before the FDA hearing, the American Society of Cataract and Refractive Surgery (ASCRS), a 10,000 member strong organization of ophthalmic surgeons, issued a press release stating the organization had formed a joint task force with FDA, National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO) to conduct a prospective post-LASIK quality of life study.  The timing of the press release seems to indicate that the LASIK industry had inside information that the FDA had no plans to act swiftly on recommendations from the public at the hearing.  The unprecedented partnership between the LASIK industry and the FDA has raised eyebrows in the patient community.  

These events followed on the heels of media reports of patients who experienced depression, and a report of suicide, due to complications from LASIK.  ASCRS fired back at the North Carolina newspaper that broke the story in February.  A flurry of bad press for the LASIK industry followed.  By early March, the LASIK industry had launched its damage control campaign by releasing preliminary findings from a meta-analysis of LASIK studies, which showed a 95% satisfaction rate.   Patients consider this meta-analysis a smokescreen to conceal the high rate of complications, such as dry eyes and night vision impairment.  Four suicides and numerous cases of depression related to LASIK were reported at the FDA hearing.  

LASIK industry leadership subsequently announced the names of doctors who were hand-picked to design and conduct the post-LASIK quality of life study with the task force.  One of the doctors selected for the study is a well-known defense expert witness who testifies against LASIK patients who file medical malpractice lawsuits, has financial ties to the LASIK industry, and has made public statements that LASIK complications do not lead to depression.  Patients believe that all of the doctors chosen for the study are biased and lack objectivity, and that the study as proposed amounts to “the fox guarding the hen house”.

In a National Public Radio interview this week, Mary Weick-Brady, an FDA spokesperson, encouraged patients to report LASIK complications to the Agency using the MedWatch program.  Weick-Brady stated that halos, starbursts, and problems with night vision are considered adverse events.  

The question that many damaged LASIK patients now want the FDA to answer is, how did a medical device with a 20% rate of adverse events receive FDA approval in the first place?

Reference:

1.  Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

Pathologic findings in postmortem corneas after successful laser in situ keratomileusis.

Kramer TR, Chuckpaiwong V, Dawson DG, L’Hernault N, Grossniklaus HE, Edelhauser HF.

Emory Eye Center, Emory University, Atlanta, GA 30322, USA.
Theresa_Kramer@emoryhealthcare.org

PURPOSE: To examine the histologic and ultrastructural features of human corneas after successful laser in situ keratomileusis (LASIK).

METHODS: Corneas from 48 eyes of 25 postmortem patients were processed for histology and transmission electron microscopy (TEM). The 25 patients had LASIK between 3 months and 7 years prior to death. Evaluation of all 5 layers of the cornea and the LASIK flap interface region was done using routine histology, periodic acid-Schiff (PAS)-stained specimens, toluidine blue-stained thick sections, and TEM.

RESULTS: In patients for whom visual acuity was known, the first postoperative day uncorrected visual acuity was 20/15 to 20/30. In patients for whom clinical records were available, the postoperative corneal topography was normal and clinical examination showed a semicircular ring of haze at the wound margin of the LASIK flap. Histologically, the LASIK flap measured, on average, 142.7 microm (range, 100-200). A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas. Findings at the flap surface included elongated basal epithelial cells, epithelial hyperplasia, thickening and undulations of the epithelial basement membrane (EBM), and undulations of Bowman’s layer. Findings in or adjacent to the wound included collagen lamellar disarray; activated keratocytes; quiescent keratocytes with small vacuoles; epithelial ingrowth; eosinophilic deposits; PAS-positive, electron-dense granular material interspersed with randomly ordered collagen fibrils; increased spacing between collagen fibrils; and widely spaced banded collagen. There was no observable correlation between postoperative intervals and the severity or type of pathologic change except for the accumulation the electron-dense granular material.

CONCLUSIONS: Permanent pathologic changes were present in all post-LASIK corneas. These changes were most prevalent in the lamellar interface wound. These changes along with other pathologic alterations in post-LASIK corneas may change the functionality of the cornea after LASIK.

 The FDA says it’s not certain how many LASIK patients have problems with their vision weeks or months after their surgeries. But the agency is planning a new study, scheduled to begin next year, to get a better handle on the prevalence. Individual consumers can also report their LASIK complications directly to the FDA. (To report complications, click here or call 1-800-FDA-1088.) “We encourage as much information as possible here, because FDA does look at every voluntary report that comes in,” says Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health. The agency uses patient reports to help determine if some new action is needed. “If it’s a decrease in vision, if it’s a halo, if it’s a starburst, if it’s a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision,” says Weick-Brady.

Full article at http://www.npr.org/templates/story/story.php?storyId=90070220

To report an adverse outcome from LASIK to the FDA, click here https://www.accessdata.fda.gov/scripts/medwatch/

Outcomes of LASIK for myopia with FDA-approved lasers.

Bailey MD, Zadnik K.

The Ohio State University College of Optometry, Columbus, OH 43210 , USA. mbailey@optometry.osu.edu

PURPOSE: To report expected outcomes of laser in situ keratomileusis (LASIK) for myopia and myopic astigmatism from existing US Food and Drug Administration (FDA) data.

METHODS: Data from Summaries of Safety and Effectiveness for each of the 12 lasers approved by the FDA for LASIK for myopia or myopic astigmatism between 1998 and 2004 were recorded from the FDA Web site. The Cochran-Armitage test for trend was used to determine whether improvements in outcomes occurred with laser technology changes.

RESULTS: For all patients, there was a statistically significant trend toward improvement with improved laser technology in the proportion of patients with uncorrected visual acuity (UCVA) of 20/20 or better, UCVA of 20/40 or better, results within +/-0.50 D of intended correction, results within +/-1.00 D of the intended correction, and night vision symptoms (all P < 0.0002). Because there were preoperative differences across laser types, subgroup analyses were also completed. The results for subgroup analyses (high myopia, low to moderate myopia, spherical myopia, and myopic astigmatism) for visual acuity and refractive error outcomes were similar to results for analyses for all groups combined. Conversely, there was no difference across laser types in the proportion of patients who experienced dry eye symptoms or for the proportion of patients with low to moderate myopia who experienced night vision symptoms that were worse or significantly worse than before LASIK.

CONCLUSIONS: LASIK provides excellent visual acuity and refractive error outcomes. Night vision and dryness symptoms still occur in a significant proportion of patients. Future studies should seek to determine whether additional changes in technology, patient selection criteria, or postoperative treatment could reduce or eliminate these symptoms.

From the full text:  “In [FDA] studies, ~15% of patients experienced night vision symptoms that were worse or significantly worse than preoperative night vision symptoms. Approximately 20% of patients experienced dryness symptoms that were worse or significantly worse than preoperative dryness.”  View complication table

Read article at http://www.newsobserver.com/business/story/1050641.html

Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations.

Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF.

Emory Eye Center, Emory University School of Medicine, Atlanta, GA 30322, USA.

PURPOSE: To measure the cohesive tensile strength of human LASIK corneal wounds.

METHODS: Twenty-five human eye bank corneas from 13 donors that had LASIK were cut into 4-mm corneoscleral strips and dissected to expose the interface wound. Using a motorized pulling device, the force required to separate the wound was recorded. Intact and separated specimens were processed for light and electron microscopy. Five normal human eye bank corneas from 5 donors served as controls. A retrospective clinical study was done on 144 eyes that had LASIK flap-lift retreatments, providing clinical correlation.

RESULTS: The mean tensile strength of the central and paracentral LASIK wounds showed minimal change in strength over time after surgery, averaging 2.4% (0.72 +/- 0.33 g/mm) of controls (30.06 +/- 2.93 g/mm). In contrast, the mean peak tensile strength of the flap wound margin gradually increased over time after surgery, reaching maximum values by 3.5 years when the average was 28.1% (8.46 +/- 4.56 g/mm) of controls. Histologic and ultrastructural correlative studies found that the plane of separation always occurred in the lamellar wound, which consisted of a hypocellular primitive stromal scar centrally and paracentrally and a hypercellular fibrotic stromal scar at the flap wound margin. The pathologic correlations demonstrated that the strongest wound margin scars had no epithelial cell ingrowth-the strongest typically being wider or more peripherally located. In contrast, the weakest wound margin scars had epithelial cell ingrowth. The clinical series demonstrated the ability to lift LASIK flaps without complications during retreatments up to 8.4 years after initial surgery, correlating well with the laboratory results.

CONCLUSIONS: The human comeal stroma typically heals after LASIK in a limited and incomplete fashion; this results in a weak, central and paracentral hypocellular primitive stromal scar that averages 2.4% as strong as normal comeal stroma. Conversely, the LASIK flap wound margin heals by producing a 10-fold stronger, peripheral hypercellular fibrotic stromal scar that averages 28.1% as strong as normal comeal stromal, but displays marked variability.

Solomon R, Donnenfeld ED, Perry HD, Rubinfeld RS, Ehrenhaus M, Wittpenn JR Jr, Solomon KD, Manche EE, Moshirfar M, Matzkin DC, Mozayeni RM, Maloney RK.

Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA.

PURPOSE: To elucidate risk factors, clinical course, visual outcomes, and treatment of culture-proven methicillin-resistant Staphylococcus aureus (MRSA) infectious keratitis following refractive surgery.

DESIGN: Interventional case series.

METHODS: Multicenter chart review of 13 cases of MRSA keratitis following refractive surgery and literature review.

RESULTS: Thirteen eyes of 12 patients, nine of whom were either healthcare workers or exposed to a hospital surgical setting, developed MRSA keratitis following refractive surgery. All patients presented with a decrease in visual acuity and complaints of pain or irritation in the affected eye. Common signs on slit-lamp biomicroscopy were corneal epithelial defects, focal infiltrates with surrounding edema, conjunctival injection, purulent discharge, and hypopyon. All patients were diagnosed with infectious keratitis on presentation and treated with two antibiotics. All eyes were culture-positive for MRSA.

CONCLUSIONS: According to a computerized MEDLINE literature search, this is the first case series of MRSA infectious keratitis following refractive surgery, the first reports of MRSA keratitis after refractive surgery in patients with no known exposure to a healthcare facility, the first report of MRSA keratitis after a laser in situ keratomileusis (LASIK) enhancement, and the first reports of MRSA keratitis after prophylaxis with fourth-generation fluoroquinolones. MRSA keratitis is a serious and increasing complication following refractive surgery. Patients with exposure to a healthcare environment should be considered at additional risk for developing MRSA keratitis. However, in addition, surgeons should now be vigilant for community-acquired MRSA. Prompt identification with culturing and appropriate treatment of MRSA keratitis after refractive surgery is important to improve visual rehabilitation.

Dry eye is the most common complication of LASIK. Corneal nerves that are responsible for tear production are severed when the flap is cut. Medical studies have shown that these severed nerves never return to normal densities and patterns. Symptoms of dry eye include pain, burning, foreign body sensation, and eyelid sticking to the eyeball. The FDA website warns that LASIK-induced dry eye may be permanent. Approximately 20% of patients in FDA clinical trials experienced “worse” or “significantly worse” dry eyes at six months after LASIK.1

2. LASIK results in loss of visual quality

LASIK patients have more difficulty seeing detail in dim light (loss of contrast sensitivity) and experience an increase in visual distortion at night (multiple images, halos, and starbursts). A published review of data for all FDA-approved lasers showed that six months after LASIK, 17.5 percent of patients reported halos, 19.7 percent reported glare (starbursts), 19.3 percent had night-driving problems and 21 percent complained of eye dryness.1  The FDA website warns that patients with large pupils may suffer from debilitating visual symptoms at night.

3. The cornea is incapable of complete wound healing after LASIK

Researchers found that the flap heals to only 2.4% of normal tensile strength.2  LASIK flaps can be surgically lifted or accidentally dislodged for the remainder of a patient’s life. The FDA website warns that patients who participate in contact sports are not good candidates for LASIK.

Collagen bands of the cornea provide its form and strength. LASIK severs these collagen bands and thins the cornea, resulting in permanent weakening. The thinner, weaker post-LASIK cornea is more susceptible to forward bulging due to normal intraocular pressure, which may progress to a condition known as keratectasia and corneal failure, requiring corneal transplant. 

4. The true rate of LASIK complications is unknown

There is no clearinghouse for reporting of LASIK complications. Moreover, there is no consensus among LASIK surgeons on the definition of a complication. The FDA allowed laser manufacturers to hide complications reported by LASIK patients in clinical trials by classifying dry eyes and night vision impairment as “symptoms” instead of complications.1

5. LASIK results in loss of near vision

Nearsighted patients who do not have LASIK retain the ability to see up close naturally after the age of 40 simply by removing their glasses. LASIK patients over the age of 40 may discover they have traded one pair of glasses for another.

6. There are long-term negative consequences of LASIK

LASIK affects the accuracy of intraocular pressure measurements, exposing patients to risk of vision loss from undiagnosed glaucoma.

Like the general population, LASIK patients will develop cataracts. Calculation of intraocular lens power for cataract surgery is inaccurate after LASIK. This may result in poor vision following cataract surgery and exposes patients to increased risk of repeat surgeries. Ironically, steroid drops routinely prescribed after LASIK may hasten the onset of cataracts.

Research demonstrates persistent decrease in corneal keratocyte density after LASIK. These cells are vital to the function of the cornea.  Ophthalmologists have speculated that this loss might lead to delayed post-LASIK ectasia.

7. Bilateral simultaneous LASIK is not in patients’ best interest

In a 2003 survey of American Society of Cataract and Refractive Surgery (ASCRS) members, 91% of surgeons who responded did not offer patients the choice of having one eye done at a time. Performing LASIK on both eyes in the same day places patients at risk of vision loss in both eyes, and denies patients informed consent for the second eye. The FDA website warns that having LASIK on both eyes at the same time is riskier than having two separate surgeries.

8. Serious complications may emerge later

The medical literature is filled with reports of late onset LASIK complications such as loss of the cornea due to biomechanical instability, vision-threatening infection, inflammation resulting in corneal haze, flap dislocation, and retinal detachment. Complications may emerge weeks, months, or years after seemingly successful LASIK.

9. Rehabilitation options after LASIK are limited

LASIK is irreversible, and treatment options for complications are extremely limited. Hard contact lenses may provide visual improvement if the patient can obtain a good fit and tolerate lenses. The post-LASIK contact lens fitting process can be time consuming, costly and ultimately unsuccessful. Many patients eventually give up on hard contacts and struggle to function with impaired vision. In extreme cases, a corneal transplant is the last resort and does not always result in improved vision.

10. Safer alternatives to LASIK exist

Some leading surgeons have already abandoned LASIK for surface treatments, such as PRK, which do not involve cutting a corneal flap. It is important to remember that LASIK is elective surgery. There is no sound medical reason to risk vision loss from unnecessary surgery. Glasses and contact lenses are the safest alternatives.

References:

1. Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.

2. Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with histologic, ultrastructural, and clinical correlations. J Refract Surg. 2005 Sep-Oct;21(5):433-45.

THE LASIK REPORT
A Call for the Discontinuation of a Harmful Procedure
Revised April, 2008

LASIK is one of the most commonly performed elective surgeries in the United States today.  The public perception of LASIK is based largely on advertising, which is intended to entice patients to have surgery without disclosing risks, side effects and contraindications.

The perceived benefits of LASIK surgery are obvious, whereas risks and adverse effects are not widely known by the general public.  It is unwise to assume that a surgeon who has a financial interest in a patient’s decision to have LASIK will provide adequate informed consent.

LASIK is irreversible and may result in long-term, debilitating complications.  There are permanent adverse effects of LASIK in 100% of cases, even in the absence of clinically significant complications.  This is unacceptable in the context of an elective surgery when safer alternatives such as glasses or contact lenses exist.

I.    BACKGROUND

When the first laser received FDA approval for LASIK, little was known about complications and long-term safety of the procedure.  Early clinical trials did not thoroughly examine adverse effects of LASIK.

Since that time, numerous medical studies have examined the risks of LASIK.  It is now widely reported in ophthalmic medical journals that complications such as dry eye and visual disturbances in low light are common, and that creation of the corneal flap permanently compromises tensile strength and biomechanical integrity of the cornea.

In 1999 during the initial boom in popularity of LASIK, Marguerite B. McDonald, noted refractive surgeon and then-Chief Medical Editor of EyeWorld magazine, stated in an editorial:

“We are only starting to ride the enormous growth curve of LASIK in this country.  There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result. Who was it who said, ‘When the tide comes in, all the boats in the harbor go up?’”

Today some prominent refractive surgeons are finding superior outcomes and better safety profiles with surface ablations such as PRK and LASEK, which avoid creation of a corneal flap.  Yet LASIK continues to be the most common refractive surgical procedure performed.

II.    DRY EYE

A report by the American Academy of Ophthalmology published in 2002 states that dry eye is the most common complication of LASIK surgery.1 Refractive surgeons are aware that LASIK induces dry eye, yet patients are not fully informed as to the etiology, chronic nature and severity of this condition. 

“My LASIK dry eye is not a minor problem, as downplayed by some ophthalmologists.  It’s a disability.  I estimate that I am blind approximately 10 percent of the time due to my eyes being closed because of the pain.  At the time of my surgery, I was told only a small number of patients experience a complication from this procedure.  There is substantial evidence that shows this crippling side effect to be relatively common.”

LASIK patient David Shell, testifying before the FDA Ophthalmic Devices Panel in August, 2002.

Persistent Dry Eye and Quality of Life after LASIK

Patients elect to undergo LASIK surgery with the expectation of improved quality of life. Instead, many are living with chronic pain from LASIK-induced dry eye.  The FDA website states that dry eyes after LASIK may be permanent (http://www.fda.gov/cdrh/LASIK/risks.htm). 

Patients should be informed that LASIK surgery severs corneal nerves that play a crucial role in tear production, and that these nerves do not return to normal.  Inability to sense and respond to dryness may lead to ocular surface damage.

Medical Research on Duration and Severity of Dry Eye

Dry eye disease is a painful, chronic condition for some patients after LASIK surgery.  In 2001, Hovanesian, Shah, and Maloney found that 48% of LASIK patients reported symptoms of dryness at least 6 months after surgery, including soreness, sharp pain and eyelid sticking to the eyeball.2

A Mayo Clinic study published in 2004 demonstrates that 3 years after LASIK, corneal nerves are less than 60% of preoperative densities.3

In 2006, researchers at Baylor College of Medicine reported the incidence of dry eyes six months after LASIK at 36% overall and 41% in eyes with superior-hinges.4  These findings were based on objective medical tests rather than patient questionnaires, which is significant as patients with nerve damage may not be capable of sensing dryness.

The scientific literature is replete with case reports and studies of LASIK-induced dry eye.  This complication is widely recognized in the industry as the most common complaint of LASIK patients, yet the problem is downplayed in the informed consent process.  Most dry eye therapies provide only marginally effective symptomatic relief.  There is no cure for LASIK-induced dry eye.  Internet bulletin boards with forums devoted to post-LASIK dry eye are a testament to this widespread, debilitating condition.

III.    NIGHT VISION IMPAIRMENT

Millions of LASIK surgeries have been performed in the United States in the past decade.  Many patients now suffer from visual impairment at night.  Some patients, especially those with large pupils, are unsafe to drive at night and can no longer live normal, independent lives.

“When I drive to work every day, fighting the DC traffic I hear lots of great advertisements including the advertisements from the center that did my surgery talking about 95, 98 percent, whatever the percentage is of their patients who achieve 20/20 or 20/40 or better vision, and they consider that a success.  I am considered a success by that criteria as well.  However, in anything but extremely bright daylight I am visually impaired by starbursts, halos, multiple ghost images because of LASIK done on my 8-millimeter pupils… FDA  approval of devices should  include  not only approval within a certain  range of  myopia or astigmatism or hyperopia but within a range of pupil  sizes such that any use of that device outside  of that  pupil size should be considered against the FDA approval of that device….”

LASIK patient, Mitch Ferro, testifying before the FDA Ophthalmic Devices Panel in July, 1999.

Unfortunately the FDA turned a deaf ear on this recommendation and did not place a pupil size limit on the approval, nor did it include large pupils in the list of LASIK contraindications.  Instead, the FDA approved lasers for LASIK with watered-down cautionary language in the labeling regarding large pupils.  Dissemination of this labeling to patients was mandated by the FDA but not enforced, which violated the right to fully informed consent for many patients with large pupils.

Reduced visual quality in dim light is frequently reported by LASIK patients.1   Patients with pupils that dilate larger than the effective optical zone of the LASIK treatment are at increased risk for debilitating visual aberrations and loss of contrast sensitivity.5  Even patients with normal pupil sizes are at risk, as the laser loses efficiency on the slope of the cornea resulting in an effective optical zone that is smaller than intended.6  Newer laser technologies attempt to compensate by applying more laser energy in the periphery of the ablation, but this technique removes more corneal tissue, increasing the risk of surgically-induced keratectasia.7

In a study published in 2004, dark-adapted pupil sizes of candidates for refractive surgery were found to range from 4.3 to 8.9 mm with a mean diameter of 6.5 mm.8  This finding explains why many patients had severe nighttime visual aberrations in the early days of photorefractive keratectomy when optical zones as small as 4 mm were used.  In an attempt to overcome pupil size/optical zone mismatch, the standard treatment zone was increased incrementally over several years.  However, even the 6.5 mm optical zone commonly used today does not prevent aberrations in many patients with large pupils, or high corrections and associated small effective optical zones.

Image degradation and visual aberrations in low light after LASIK were predictable.  These problems had been widely recognized and reported with previous refractive surgeries such as radial keratotomy (RK) and photorefractive keratectomy (PRK), and were related to pupil size.9  If corneal refractive power is not consistent across the entire diameter of the pupil, visual aberrations and loss of contrast sensitivity result.  After cataract surgery or refractive lens exchange, patients also report poor vision at night when the pupil dilates.  As phakic intraocular lenses begin to replace LASIK for high myopia due to safety concerns, the pattern of patients with large pupils experiencing night vision disturbances is consistent.

Public Health Concerns Following LASIK Surgery

Dr. Leo Maguire forewarned of the threat to public health posed by impaired night vision following refractive surgery.10 The following is an excerpt from an editorial published in the March, 1994 edition of American Journal of Ophthalmology:

“I hope the reader will now understand how a patient may have clinically acceptable 20/20 visual acuity in the daytime and still suffer from clinically dangerous visual aberration at night if that patient’s visual system must cope with an altered refractive error, increased glare, poorer contrast discrimination, and preferentially degraded peripheral vision.  People die at night in motor vehicle accidents four times as frequently as they do during the day, and these figures are adjusted for miles driven.  Night driving presents a hazardous visual experience to adults without aberrations.  When we discuss aberration at night we are considering a possible morbid effect of refractive surgery.”

A Brief Chronology of Scientific Literature on Night Vision Impairment after Corneal Refractive Surgery

Factors responsible for visual impairment in low light following refractive surgery have been discussed in articles and reported in peer-reviewed studies for two decades:   

1987 “For a patient to have a zone of glare-free vision centered on the point of fixation, the optical zone of the cornea must be larger than the entrance pupil.  The larger the optical zone, the larger the field of glare-free vision.”11
 
1993 “Optical zone diameters must be at least as large as the entrance pupil diameter to preclude glare at the fovea, and larger than the entrance pupil to preclude parafoveal glare.”12
 
1996 “At nighttime, when the pupil dilates, rays from treated and untreated areas of the cornea reach the retina at different foci and produce haloes.”13
 
1997 “Corneal modulation transfer function calculations suggest that a significant loss of visual performance should be anticipated following photorefractive keratectomy, the effect being the greatest for large pupil diameters.”14
 
1998 “…after PRK, the diameter of the entrance pupil greatly affects the amount and character of the aberrations…”15
 
1999 “Changes in functional vision worsen as the target contrast diminishes and the pupil size increases.”16
 
2000 “The increase in ocular aberrations was significantly related with the virtual pupil size.”17 

“Thus, an optical system may have no refractive error in the center of the pupil and an increasing error in the annular zones surrounding the pupil center.  The resultant image may be sharp for small pupil diameters but degrade as the pupil expands.”18
 
2002 “The relation between pupil size and the optical clear zone are most important in minimizing these disturbances in RK.  In PRK and LASIK, pupil size and the ablation diameter size and location are the major factors involved.” 19

The LASIK industry failed to take corrective action in response to scientific evidence regarding the importance of matching the effective optical zone to a patient’s pupil size.  As a result, many LASIK patients are now permanently visually impaired in dim light.

IV.    IATROGENIC KERATECTASIA

The cornea is under constant stress from normal intraocular pressure pushing outward.  Collagen bands of the cornea provide its form and biomechanical strength.  LASIK thins the cornea and severs collagen bands, permanently weakening the cornea.  This results in forward bulging of the cornea, which may progress to a condition known as keratectasia, characterized by loss of best corrected vision and possible corneal failure requiring corneal transplant.

The FDA, laser manufacturers, and refractive surgeons are aware of limits on flap thickness, ablation depth, and diameter of the optical zone imposed by corneal biomechanics.  When the FDA initially approved lasers for LASIK, it established a minimum of 250 microns of corneal tissue under the flap after LASIK surgery to prevent corneal instability and progressive forward bulging.  Subsequent reports in medical literature indicate that 250 microns is not sufficient to ensure corneal biomechanical stability.20,21  In response, some surgeons stopped performing LASIK or raised the residual stromal thickness limit in their practices.  However, the majority of surgeons continue to observe the 250 micron rule initially established by the FDA, even though this limit has been shown to be insufficient.

The 250 micron rule is often violated inadvertently during surgery, as microkeratomes that cut the LASIK flap are unpredictable and produce flaps of varying thickness.22   For this reason, flap thickness should be measured intraoperatively.  Most surgeons have not incorporated this important measurement into the surgical procedure prior to ablation, which places patients with thicker-than-expected flaps at greater risk.

Keratectasia may develop months or years following seemingly successful LASIK.23  Since most cases are never reported, the true rate of this devastating complication may never be known.  The only way to prevent surgically induced keratectasia is to abandon LASIK altogether.  It is important to remember that LASIK is elective surgery.  There is no sound medical reason to place patients at risk of vision loss from unnecessary surgery.

V.    LIMITED HEALING OF THE CORNEA FOLLOWING LASIK

The human cornea is incapable of complete wound healing after LASIK surgery.  In 2005, researchers at Emory University found permanent pathologic changes in all post-LASIK corneas examined, including undulation of Bowman’s layer, spatial separation of the LASIK flap from the stromal bed, epithelial thickening over the wound margin, interface debris, and severed and severely disordered collagen fibrils.24  The study reveals that the healing response never completely regenerates normal corneal stroma.

Another study demonstrates that the LASIK flap produces a scar at the margin that is only 28.1% of the tensile strength of normal corneal stroma, and the flap itself heals to only 2.4% of normal tensile strength.25  This publication reports that one author has lifted LASIK flaps out to 11 years after initial surgery, further attesting to long-term weakness of the LASIK interface wound.  Reports of late flap dislocations suggest that LASIK patients are vulnerable to traumatic flap injury for life. 26

VI.    OTHER COMPLICATIONS AND CONCERNS

Potential Complications of LASIK

Other vision-threatening complications are seen following LASIK surgery, such as infection, retinal breaks and detachment, macular holes and hemorrhage, optic nerve damage, diffuse lamellar keratitis, irregular flaps, flap folds and striae, slipped flaps, epithelial defects, and epithelial ingrowth.  These and other complications may have severe, lasting adverse effects.

Bilateral Simultaneous LASIK

Performing LASIK on both eyes in the same day is convenient and financially beneficial for surgeons, but is not in patients’ best interest.  In a 2003 survey of American Society of Cataract and Refractive Surgery (ASCRS) members, 91% of surgeons who responded did not offer patients the choice of having one eye done at a time.27  Bilateral simultaneous LASIK places patients at risk of vision loss in both eyes, and denies patients informed consent for the second eye.

Inaccurate IOP Measurement after LASIK

Changes in corneal thickness and biomechanical properties following LASIK affect intraocular pressure (IOP) measurements, resulting in falsely low readings.  LASIK patients face lifetime risk of undiagnosed ocular hypertension, which may progress to glaucoma.  Glaucoma is a leading cause of blindness.

Complicated Cataract Surgery after LASIK

Like the general population, LASIK patients will eventually develop cataracts.  The altered corneal surface following LASIK prevents accurate measurement of intraocular lens power for cataract surgery.  This may result in a “refractive surprise” following cataract surgery and exposes LASIK patients to increased risk of repeat surgeries.

LASIK Results in Loss of Near Vision

Patients are routinely misinformed that they will require reading glasses after the age of 40 whether they have LASIK or not.  Nearsighted patients who do not have refractive surgery actually retain the ability to see up close naturally after the age of 40 simply by removing their glasses.  LASIK increases the need for reading glasses by changing the eye’s focus from near to distance.  The loss of near vision after myopic-LASIK affects many daily activities, not just reading.  LASIK patients over the age of 40 may discover they have simply traded one pair of glasses for another.

Progressive Loss of Corneal Keratocytes after LASIK

A Mayo Clinic study demonstrates persistent decrease in corneal keratocyte density after LASIK.28  Keratocytes are cells vital to the function of the cornea.  This progressive loss of corneal keratocytes may have long-term implications in terms of corneal stability, refractive stability and cellular integrity of the cornea after LASIK.  Ophthalmologists have speculated that progressive keratocyte loss may ultimately lead to post-LASIK ectasia. 28,29

Limited Rehabilitation Options after LASIK

LASIK is irreversible, and treatment options for visual rehabilitation after a poor LASIK outcome are extremely limited.  Rigid gas permeable contact lenses may improve vision if the patient can tolerate lenses and obtain a good fit.  The post-LASIK contact lens fitting process can be time consuming, expensive, and complicated by LASIK-induced dry eyes.  Many patients eventually give up on hard contacts and struggle to function with impaired vision.  In extreme cases, a corneal transplant may be required.

VII.    PATIENT SATISFACTION

LASIK success is measured by the LASIK industry as uncorrected visual acuity under bright illumination.  Patients seeking vision correction are most concerned with elimination of glasses or contact lenses, and are unaware of what it means to lose visual quality.  Patient surveys typically show a high level of satisfaction with LASIK.  However, an alarming number of satisfied patients also report complications such as visual disturbances in dim light and dry eye.

In the March, 1994 American Journal of Ophthalmology editorial mentioned previously in this article, Dr. Leo Maguire cautioned about misleading implications of quoting patient satisfaction rates:10

“A keratorefractive patient may simultaneously be happy with the result of surgery and have degraded vision – how can refractive surgery be a potential public health problem if patients are happy with the results? Inherent in this question is the assumption that a patient without complaint is a patient without optical degradation. That argument does not hold up to closer scrutiny. The keratorefractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents and yet they are happy with the results.” 

In May, 2001, results from a questionnaire completed by PRK and LASIK patients revealed that 19.5% reported a worsening in functioning, 27.1% a worsening in symptoms, 34.9% a worsening in optical problems, 33.7% a worsening in glare, and 41.5% a worsening in driving.30

In one report, researchers suggest that factors such as the Hawthorne effect and cognitive dissonance may play a role in patient satisfaction following LASIK.31  The Hawthorne effect favorably influences patients’ survey responses merely because patients are aware that they are enrolled in a study.  Cognitive dissonance is a change in one’s attitude or beliefs to eliminate internal conflict with negative consequences of an irreversible action.

LASIK industry representatives have argued that no evidence links a poor LASIK outcome with depression or suicide.  However, if it is credible that there may be a positive impact on quality of life after seemingly successful LASIK, then we must also accept that there can be a negative impact on quality of life after a poor LASIK outcome.

VIII.    NEWER TECHNOLOGIES

Wavefront-guided and wavefront-optimized LASIK

Newer laser technologies were designed to reduce induction of aberrations and night vision disturbances. As complications from current technologies generate bad publicity, pressures to develop and market alternative technologies emerge.  “Real” complication rates are openly discussed, not when a procedure is popular, but rather when providers push newer, “improved” technology.  The LASIK industry and LASIK surgeons aggressively promote new technologies as “safer and more effective,” blaming older technologies for past complications.  Although the introduction of wavefront-LASIK was surrounded by hype, studies have shown that wavefront-guided and wavefront-optimized LASIK actually increase, not decrease, higher order aberrations, reducing visual quality in previously untreated eyes.32,33  A review of literature on wavefront-guided LASIK concludes that evidence does not support claims that wavefront outperforms conventional LASIK.34  Wavefront, like previous forms of refractive surgery, fails to deliver on its promises.

Femtosecond laser flap creation (Intralase-LASIK)

Mechanical blade microkeratomes have been linked to flap complications and damage to the epithelium.  The femtosecond laser keratome is currently promoted as a safer alternative.  Studies have shown that the femtosecond laser produces flaps with smaller deviations from planned thickness than mechanical microkeratomes.  However, it does not reduce most complications associated with the LASIK procedure and has been linked to extreme light sensitivity,35 a complication of this technology.  Femtosecond laser flaps are more difficult to lift than flaps created with a blade, which may result in a higher incidence of torn flaps.

The femtosecond laser keratome currently requires longer suction on the eye than blade microkeratomes to create the LASIK flap.  The incidence of posterior vitreous detachment with blade microkeratomes is high at 13% overall, and 24% for patients with high myopia in one study.36  Increased suction ring exposure associated with use of femtosecond lasers likely induces posterior vitreous detachment at even higher rates, as well as other serious complications such as retinal detachment, macular hemorrhage, retinal vein occlusion, and optic nerve damage following LASIK.

A search of peer-reviewed literature reveals problems associated with the femtosecond laser such as slipped flaps, interface inflammation, flap folds, infectious keratitis, corneal stromal inflammation, delayed wound healing, macular hemorrhage, and gas bubbles in the anterior chamber after surgery.37-43  The FDA medical device adverse events database (http://www.fda. gov/cdrh/maude.html) contains numerous reports involving femtosecond laser keratomes.

IX.    CONCLUSION

Vision has always been considered the most important of the five senses. Vision loss, particularly as a result of an elective surgery, may bring about acute distress greater than that resulting from other sensorial impairment. LASIK surgery is performed on healthy eyes with good correctable vision; therefore, LASIK should be held to higher standards than other elective medical procedures. 

Criteria used by the industry to measure LASIK outcomes fail to include induced visual disturbances, dry eyes, pathologic changes to the cornea and the psychological impact of a poor result.

Patients are denied the whole truth about the negative effects of LASIK; therefore, they are unable to give informed consent. The LASIK industry has been unresponsive to medical research findings, which should have resulted in a higher standard of care.  Instead, LASIK surgeons have resisted raising the standard of care in order to maintain the potential pool of candidates and to protect themselves from liability.

The American Medical Association endorses certain principles of medical ethics.  One principle states that: “A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.” (http://www.ama-assn.org/ama/ pub/category/2512.html).  The white wall of silence called for by Dr. Marguerite McDonald in 1999 violates this principle.

There has been and continues to be a pattern within the refractive surgery industry placing patients’ interests secondary to financial interests.  Physicians are ethically bound to put the best interests of patients first.  LASIK is an unnecessary