Although the marketing of LASIK focuses on quality of life, informed consent does not. Instead, the real risks are hidden in medical jargon that never mentions their true effects, particularly severe depression and suicidal ideation.
Right now, there are many Lasik casualties worldwide struggling to...
- Cope with depression and suicidal ideation, medical disease syndromes not explicitly mentioned on their informed consent.
- Cope with the symptoms of post-traumatic stress (PTSD) and other anxiety disorders.
- Cope with their surgeons telling them that nothing is wrong with their eyes.
- Cope with "second opinions" designed to protect their surgeon from legal problems.
- Find a hard contact lens to fit their irregular corneas, often spending thousands and thousands of dollars hunting for a suboptimal solution.
- Cope with the possibility of losing their jobs, homes, or spouses because of sudden, permanent visual loss.
- Cope with three, four, or five complications at the same time.
- Cope with the need to put drops in their eyes every few minutes, to stop a burning that will NOT go away.
- Cope with the need to drive (provided you still can) while looking at multiple images of traffic and people (or even as a passenger).
- Cope with the need to work, while being barely able to read for long periods, or even read at all.
- Cope with intense feelings of guilt and self-blame because they trusted their doctors.
- Cope with not knowing what the future holds for them or their vision.
- Cope with pressure from their loved ones who don't understand to "shape up".
How would you feel if you received an infectious disease or permanent injury caused by the reuse of an FDA "regulated" medical device AFTER the CDC and the FDA knew about an unsafe risk and did nothing?
Many Microkeratome components used for LASIK are licensed, "regulated" and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.
Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).
The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices. Not everything that a medical Doctor does is considered the practice of medicine. Being a licensed medical Doctor does Not allow a person to break Federal or State laws.
An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine. However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition. Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.
Why isn't any practitioner or user of these FDA "regulated" (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?
The House of representatives has investigated the FDA regarding allowing these harmful practices (as reported in the Washington Post). "If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it," he said. "It's common sense."
"The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade"
Microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems.
The FDA hasn't even responded to a request for humanitarian aid or compassionate use of a medical device. They don't do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting an "off-label" treatment, but when the FDA was asked to simply put in writing that the manufacturer and a Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching an actual pupil size), the FDA would Not put it in writing. Is that humanitarian or compassionate?
"IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them? As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision. My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records). One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision. I was shocked when he said "I know many patients who would be happy with your vision". I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?"
"LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them. Former patients may have been exposed to infectious diseases such as HIV or Hepatitis."
"I must protest - there could never be legitimate reasons for placing patients at incredible risk of HIV, viral hepatitis, or Mad Cow disease - all which can potentially be transmitted via the use of unsterilized sharp instruments. There is absolutely no excuse for this. It goes against every medical standard and as well goes against the laser centers licensing by OSHA (a governmental organization that certifies that surgery centers are following the appropriate blood borne pathogen. And I have to say that your organization will lose complete credibility if this type of action is excused. These surgeons and the laser centers put their patients at severe risk. You can't look back and say no one was injured, so their actions were OK. Mad Cow Disease (Jacob-Creutzfeld) can be transmitted via the cornea (there are documented cases of patients transmitting this disease following corneal transplants) - and this disease may take 20-40 years to show up. As well, HIV is known to be present in tears - and blood is not an uncommon sight with LASIK."
"I thought surely the eye Doctors' Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients' safety. Think again."
"At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization]."
Live virus survives excimer laser ablation
Opthalmology 1999 Aug;106(8):1498-9
Taravella MJ, Weinberg A, May M, Stepp P.
OBJECTIVES: To determine whether live virus can withstand excimer laser ablation and pose a possible health hazard to medical personnel.
DESIGN: Experimental study.
METHODS: Fibroblasts infected with oral polio vaccine virus were ablated with an excimer laser. The plume was collected using a smoke evacuator and bubbled through viral culture media.
MAIN OUTCOME MEASURES: The inlet tube from the smoke evacuator was swabbed and cultured for virus. Liquid from the bubble trap was also cultured.
RESULTS: Live virus was shown in the material trapped from the laser plume.
CONCLUSIONS: Oral polio vaccine virus can survive excimer laser ablation. Whether other more clinically relevant viruses, such as human immunodeficiency virus, can withstand ablation and remain infectious remains to be determined.
Aerosolization of infectious virus by excimer laser
American Journal of Ophthalmology 1997 March, 123(3):297-302
Moreira LB, Sanchez D, Trousdale MD, Stevenson D, Yarber F, McDonnell PJ. Doheny Eye Institute, Los Angeles, CA 90033, USA.
PURPOSE: To determine the potential for aerosolization of infectious virus present within the tear film during excimer laser photoablation of the cornea.
METHODS: Cell monolayers infected with herpes simplex virus or adenovirus, simulating virus-infected corneas, were ablated with the 193-nm excimer laser. Adjacent dishes containing noninfected cell monolayers were subsequently assayed for viral infection.
RESULTS: Viral spread to sentinel dishes occurred with both herpes simplex and adenovirus. The titer of virus present in the infected cell monolayers influenced the likelihood of spread to adjacent dishes. The presence of a vacuum aspiration system appeared to influence the direction of virus spread, with dishes located in the direction of the vacuum most likely to contain virus.
CONCLUSIONS: The potential for aerosolization of infectious virus exists with photoablation using a large-diameter excimer laser beam. Our experimental design, however, does not prove that spread of infectious virus is likely to occur in the clinical setting. Appropriate measures should be taken to reduce the possibility of the spread of virus from the patient to the surgeon, other medical staff, or other patients.
PMID: 9063238 [PubMed - indexed for MEDLINE]
Epidemic and sporadic cases of nontuberculous mycobacterial keratitis associated with LASIK
a) Epidemiology Program Office (K.L.W., E.B.S., M.A.K., A.W.), Centers for Disease Control and Prevention, Atlanta, Georgia, USA b) California Department of Health Services (S.B.W., A.W., D.J.V), Berkeley, California, USA c) Division of Public Health (E.B.S.), Georgia Department of Human Resources, Atlanta, Georgia, USA d) Scott and White Clinic (G.H.), Temple, Texas, USA - Accepted 30 August 2002. ; Available online 28 January 2003.
Purpose: To report national case-finding results for nontuberculous mycobacterial keratitis and describe its association with laser in situ keratomileusis (LASIK).
Design: Enhanced passive disease reporting.
Methods: In April 2001, we investigated a California cluster of Myco bacterium chelonae keratitis associated with hyperopic LASIK using a contact lens mask. To identify other possibly related cases, the American Academy of Ophthalmology e-mailed its members asking them to report recent cases of nontuberculous mycobacterial keratitis to the Centers for Disease Control and Prevention.
Results: Forty-three additional cases of keratitis were reported (onsets between August 2000 and June 2001). Of these, 31 occurred as part of two unrelated LASIK- associated outbreaks. The 12 other reported cases occurred in sporadic fashion. Of the latter cases, 4 were associated with LASIK surgery. None of the reported cases were related to the M. chelonae cluster in California.
Conclusions: Laser in situ keratomileusis-associated keratitis with nontuberculous mycobacteria may be more common than previously known.
"Dry eye occurs when people don’t have either enough tears, or the correct composition of tears, on the surface of their eyes to lubricate the eyes and keep them comfortable.”. . .“If you have dry eye, your eyes can feel persistently gritty, itchy, burning, and painful.”
Take the dry eye test. Let's mention some, not all, of just the dry eye problems that may effect these hundreds of thousands+ of people. Notice these end in dysfunction or "itis" meaning "Inflammation or disease of" and "Excessive preoccupation with, indulgence in, reliance on, or possession of the qualities of". Blepharitis, Mebomian or Lacrimal Gland Dysfunction (mebomianitis), conjuntivitis, and keratoconjunctivitis sicca. Keratitis (Inflammation of the cornea)- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK).
It is so difficult to grasp the magnitude of the impact that I asked some others who are suffering greatly after LASIK for their comments on how to explain the degree of suffering and constantness of it better. For additional research and a patient story on the permanent impact on Quality of Life.
There are many reasons why LASIK causes dry eye. From reading the literature and talking with patients my estimate is that if a blade is reused for LASIK, then all patients' eyes are drier after LASIK than before, 10 to 50% of eyes are so permanently dry that they use preservative free (if they're properly informed) eye drops for the rest of their life, and that 10 to 20% of patients are so severely effected by dry eye that it dramatically changes their life forever. Even without any eye surgery or LASIK, over 3 million people have dry eyes. Also, most prescription medicaions cause dry eyes which means millions more people have dry eyes even before they have LASIK.
A Call for the Discontinuation of a Harmful Procedure
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. 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.
In 1998, 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 stated 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 receiving full informed consent 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 the 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 since its approval in 1998. Many patients now suffer from visual impairment at night. Some of these 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 full 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 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 IOLs 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 vision following refractive surgery.10 The following is an excerpt from an editorial published in the March, 1994 edition of the 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 nearly two decades.
“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
“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
“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
“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
“…after PRK, the diameter of the entrance pupil greatly affects the amount and character of the aberrations…”15
“Changes in functional vision worsen as the target contrast diminishes and the pupil size increases.”16
“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
“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. The 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 flaps at increased risk.
Keratectasia may develop months or years following LASIK.23 Since most cases are never reported, the true rate of this devastating complication may never be known. The safest solution for patients would be 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 recent 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 The article 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
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.
Inaccurate IOP Measurement after LASIK
The changes in corneal thickness and curvature following LASIK affect intraocular pressure measurements, resulting in falsely low readings. LASIK patients face lifetime risk of undiagnosed high intraocular pressure (glaucoma), a leading cause of blindness.
Cataract Surgery after LASIK
Like the general population, LASIK patients will develop cataracts later in life. The altered corneal surface following LASIK prevents accurate measurement of intraocular lens power for cataract surgery. This may result in a “refractive surprise” for LASIK patients following cataract surgery and exposes them 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.
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 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 symptoms such as visual disturbances in dim light and dry eye.
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.27
In one report, researchers suggest that factors such as the Hawthorne effect and cognitive dissonance may play a role in patient satisfaction following LASIK.28 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.
VIII. NEWER TECHNOLOGIES
Wavefront-guided and wavefront-optimized LASIK
Newer laser technologies were designed to reduce induction of new aberrations and prevent 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.29,30 A recently published review of literature on wavefront-guided LASIK concludes that evidence does not support claims that wavefront outperforms conventional LASIK.31 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,32 a new 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.33 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.34-40 The FDA medical device adverse events database (http://www.fda.gov/cdrh/maude.html) contains numerous reports involving femtosecond laser keratomes.
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 results of medical research, 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. 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. Medical doctors are ethically bound to put the best interests of patients first. LASIK is an unnecessary surgical procedure that permanently damages the eyes of every patient; therefore it is a violation of a primary principle of medicine, "First, Do No Harm". As such, the practice of LASIK should be discontinued.
1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for myopia and astigmatism: Safety and efficacy. A report by the American Academy of Ophthlamology. Ophthalmology. 2002 Jan;109(1):175-87.
2. Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg. 2001 Apr;27(4):577-84.
3. Calvillo MP, McLaren JW, Hodge DO, Bourne WM. Corneal reinnervation after LASIK: prospective 3-year longitudinal study. Invest Ophthalmol Vis Sci. 2004 Nov;45(11):3991-6.
4. De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, Wilhelmus KR, Pflugfelder SC. The incidence and risk factors for developing dry eye after myopic LASIK. Am J Ophthalmol. 2006 Mar; 141(3):438-45.
5. Schwiegerling J, Snyder RW. Corneal ablation patterns to correct for spherical aberration in photorefractive keratectomy. J Cataract Refract Surg. 2000 Feb;26(2):214-21.
6. Hersh PS, Fry K, Blaker JW. Spherical aberration after laser in situ keratomileusis and photorefractive keratectomy. Clinical results and theoretical models of etiology. J Cataract Refract Surg. 2003 Nov;29(11):2096-104.
7. Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront optimized ablation profiles. Theoretical background. J Cataract Refract Surg. 2004 Apr;30(4):775-85.
8. Netto MV, Ambrosio R Jr, Wilson SE. Pupil size in refractive surgery candidates. J of Refract Surg. 2004 Jul-Aug;20(4):337-42.
9. Hjortdal JO, Olsen H, Ehlers N. Prospective randomised study of corneal aberrations 1 year after radial keratotomy or photorefractive keratectomy. J Refract Surg. 2002 Jan-Feb;18(1):23-9.
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