LASIK surgical machines
   HOME

TheInfoList



OR:

LASIK or Lasik (''
laser A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". The fi ...
-assisted
in situ ''In situ'' (; often not italicized in English) is a Latin phrase that translates literally to "on site" or "in position." It can mean "locally", "on site", "on the premises", or "in place" to describe where an event takes place and is used in ...
keratomileusis Keratomileusis, from Greek κέρας (kéras: horn) and σμίλευσις (smíleusis: carving),The word is derived from Greek κέρας - keras (root: kerat-) "horn, cornea" and σμίλευσις - smileusis "carving or corneal reshaping, is ...
''), commonly referred to as laser eye surgery or laser vision correction, is a type of refractive surgery for the correction of myopia,
hyperopia Far-sightedness, also known as long-sightedness, hypermetropia, or hyperopia, is a condition of the eye where distant objects are seen clearly but near objects appear blurred. This blurred effect is due to incoming light being focused behind, i ...
, and an actual cure for
astigmatism Astigmatism is a type of refractive error due to rotational asymmetry in the eye's refractive power. This results in distorted or blurred vision at any distance. Other symptoms can include eyestrain, headaches, and trouble driving at n ...
, since it is in the cornea. LASIK surgery is performed by an ophthalmologist who uses a
laser A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". The fi ...
or
microkeratome A microkeratome is a precision surgical instrument with an oscillating blade designed for creating the corneal flap in LASIK or ALK surgery. The normal human cornea varies from around 500 to 600 micrometres in thickness; and in the LASIK procedur ...
to reshape the eye's
cornea The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber. Along with the anterior chamber and lens, the cornea refracts light, accounting for approximately two-thirds of the eye's total optical ...
in order to improve
visual acuity Visual acuity (VA) commonly refers to the clarity of vision, but technically rates an examinee's ability to recognize small details with precision. Visual acuity is dependent on optical and neural factors, i.e. (1) the sharpness of the retinal ...
. For most people, LASIK provides a long-lasting alternative to
eyeglasses Glasses, also known as eyeglasses or spectacles, are vision eyewear, with lenses (clear or tinted) mounted in a frame that holds them in front of a person's eyes, typically utilizing a bridge over the nose and hinged arms (known as temples or ...
or contact lenses. LASIK is very similar to another surgical corrective procedure,
photorefractive keratectomy Photorefractive keratectomy (PRK) and laser-assisted sub-epithelial keratectomy (or laser epithelial keratomileusis) (LASEK) are laser eye surgery procedures intended to correct a person's vision, reducing dependency on glasses or contact lense ...
(PRK), and LASEK. All represent advances over radial keratotomy in the surgical treatment of
refractive error Refractive error, also known as refraction error, is a problem with focusing light accurately on the retina due to the shape of the eye and or cornea. The most common types of refractive error are near-sightedness, far-sightedness, astigmatism ...
s of vision. For patients with moderate to high myopia or thin corneas which cannot be treated with LASIK and PRK, the
phakic intraocular lens A phakic intraocular lens (PIOL) is a special kind of intraocular lens that is implanted surgically into the eye to correct myopia (nearsightedness). It is called "phakic" (meaning "having a lens") because the eye's natural lens is left untouched. ...
is an alternative. As of 2018, roughly 9.5 million Americans have had LASIK and, globally, between 1991 and 2016, more than 40 million procedures were performed. However, the procedure seemed to be a declining option as of 2015.


Process

The planning and analysis of
corneal The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber. Along with the anterior chamber and lens, the cornea refracts light, accounting for approximately two-thirds of the eye's total optical powe ...
reshaping techniques such as LASIK have been standardized by the American National Standards Institute, an approach based on the Alpins method of astigmatism analysis. The FDA website on LASIK states, : "Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so." The procedure involves creating a thin flap on the eye, folding it to enable remodeling of the tissue beneath with a laser and repositioning the flap.


Preoperative procedures


Contact lenses

Patients wearing soft
contact lenses Contact lenses, or simply contacts, are thin lenses placed directly on the surface of the eyes. Contact lenses are ocular prosthetic devices used by over 150 million people worldwide, and they can be worn to correct vision or for cosmeti ...
are instructed to stop wearing them 5 to 21 days before surgery. One industry body recommends that patients wearing hard contact lenses should stop wearing them for a minimum of six weeks plus another six weeks for every three years the hard contacts have been worn. The cornea is avascular because it must be transparent to function normally. Its cells absorb
oxygen Oxygen is the chemical element with the symbol O and atomic number 8. It is a member of the chalcogen group in the periodic table, a highly reactive nonmetal, and an oxidizing agent that readily forms oxides with most elements as ...
from the
tear film Tears are a clear liquid secreted by the lacrimal glands (tear gland) found in the eyes of all land mammals. Tears are made up of water, electrolytes, proteins, lipids, and mucins that form layers on the surface of eyes. The different types of ...
. Thus, low-oxygen-permeable contact lenses reduce the cornea's oxygen absorption, sometimes resulting in
corneal neovascularization Corneal neovascularization (CNV) is the in-growth of new blood vessels from the pericorneal plexus into avascular corneal tissue as a result of oxygen deprivation. Maintaining avascularity of the corneal stroma is an important aspect of corneal ...
—the growth of blood vessels into the cornea. This causes a slight lengthening of inflammation duration and healing time and some pain during surgery, because of greater bleeding. Although some contact lenses (notably modern RGP and soft silicone hydrogel lenses) are made of materials with greater oxygen permeability that help reduce the risk of corneal neovascularization, patients considering LASIK are warned to avoid over-wearing their contact lenses.


Pre-operative examination and education

In the United States, the FDA has approved LASIK for age 18 or 22 and over because the vision has to stabilize. More importantly the patient's eye prescription should be stable for at least one year prior to surgery. The patient may be examined with pupillary dilation and education given prior to the procedure. Before the surgery, the patient's
cornea The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber. Along with the anterior chamber and lens, the cornea refracts light, accounting for approximately two-thirds of the eye's total optical ...
s are examined with a pachymeter to determine their thickness, and with a topographer, or corneal topography machine, to measure their surface contour. Using low-power
laser A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. The word "laser" is an acronym for "light amplification by stimulated emission of radiation". The fi ...
s, a topographer creates a
topographic map In modern mapping, a topographic map or topographic sheet is a type of map characterized by large- scale detail and quantitative representation of relief features, usually using contour lines (connecting points of equal elevation), but histori ...
of the cornea. The procedure is contraindicated if the topographer finds difficulties such as keratoconus The preparatory process also detects
astigmatism Astigmatism is a type of refractive error due to rotational asymmetry in the eye's refractive power. This results in distorted or blurred vision at any distance. Other symptoms can include eyestrain, headaches, and trouble driving at n ...
and other irregularities in the shape of the cornea. Using this information, the surgeon calculates the amount and the location of corneal tissue to be removed. The patient is prescribed and self-administers an antibiotic beforehand to minimize the risk of infection after the procedure and is sometimes offered a short acting oral sedative medication as a pre-medication. Prior to the procedure, anaesthetic eye drops are instilled. Factors that may rule out LASIK for some patients include large pupils, thin corneas and extremely dry eyes.


Operative procedure


Flap creation

A soft corneal suction ring is applied to the eye, holding the eye in place. This step in the procedure can sometimes cause small blood vessels to burst, resulting in bleeding or
subconjunctival hemorrhage Subconjunctival bleeding, also known as subconjunctival hemorrhage or subconjunctival haemorrhage, is bleeding from a small blood vessel over the whites of the eye. It results in a red spot in the white of the eye. There is generally little to no ...
into the white ( sclera) of the eye, a harmless side effect that resolves within several weeks. Increased suction causes a transient dimming of vision in the treated eye. Once the eye is immobilized, a flap is created by cutting through the
corneal epithelium The corneal epithelium (epithelium corneæ anterior layer) is made up of epithelial tissue and covers the front of the cornea. It acts as a barrier to protect the cornea, resisting the free flow of fluids from the tears, and prevents bacteria fro ...
and Bowman's layer. This process is achieved with a mechanical
microkeratome A microkeratome is a precision surgical instrument with an oscillating blade designed for creating the corneal flap in LASIK or ALK surgery. The normal human cornea varies from around 500 to 600 micrometres in thickness; and in the LASIK procedur ...
using a metal blade, or a femtosecond laser that creates a series of tiny closely arranged bubbles within the cornea. A hinge is left at one end of this flap. The flap is folded back, revealing the stroma, the middle section of the cornea. The process of lifting and folding back the flap can sometimes be uncomfortable.


Laser remodeling

The second step of the procedure uses an excimer laser (193 nm) to remodel the corneal stroma. The laser vaporizes the tissue in a finely controlled manner without damaging the adjacent stroma. No burning with heat or actual cutting is required to ablate the tissue. The layers of tissue removed are tens of
micrometers The micrometre ( international spelling as used by the International Bureau of Weights and Measures; SI symbol: μm) or micrometer (American spelling), also commonly known as a micron, is a unit of length in the International System of Unit ...
thick. Performing the laser ablation in the deeper corneal stroma provides for more rapid visual recovery and less pain than the earlier technique,
photorefractive keratectomy Photorefractive keratectomy (PRK) and laser-assisted sub-epithelial keratectomy (or laser epithelial keratomileusis) (LASEK) are laser eye surgery procedures intended to correct a person's vision, reducing dependency on glasses or contact lense ...
(PRK). During the second step, the patient's vision becomes blurry, once the flap is lifted. They will be able to see only white light surrounding the orange light of the laser, which can lead to mild disorientation. The excimer laser uses an eye tracking system that follows the patient's eye position up to 4,000 times per second, redirecting laser pulses for precise placement within the treatment zone. Typical pulses are around 1
millijoule The joule ( , ; symbol: J) is the unit of energy in the International System of Units (SI). It is equal to the amount of work done when a force of 1 newton displaces a mass through a distance of 1 metre in the direction of the force applied. ...
(mJ) of pulse energy in 10 to 20 nanoseconds.


Repositioning of the flap

After the laser has reshaped the stromal layer, the LASIK flap is carefully repositioned over the treatment area by the surgeon and checked for the presence of air bubbles, debris, and proper fit on the eye. The flap remains in position by natural adhesion until healing is completed.


Postoperative care

Patients are usually given a course of antibiotic and anti-inflammatory eye drops. These are continued in the weeks following surgery. Patients are told to rest and are given dark eyeglasses to protect their eyes from bright lights and occasionally protective goggles to prevent rubbing of the eyes when asleep and to reduce dry eyes. They also are required to moisturize the eyes with preservative-free tears and follow directions for prescription drops. Occasionally after the procedure a bandage contact lens is placed to aid the healing, and typically removed after 3–4 days. Patients should be adequately informed by their surgeons of the importance of proper post-operative care to minimize the risk of complications.


Wavefront-guided

Wavefront-guided LASIK is a variation of LASIK surgery in which, rather than applying a simple correction of only long/short-sightedness and astigmatism (only lower order aberrations as in traditional LASIK), an ophthalmologist applies a spatially varying correction, guiding the computer-controlled excimer laser with measurements from a
wavefront In physics, the wavefront of a time-varying '' wave field'' is the set ( locus) of all points having the same '' phase''. The term is generally meaningful only for fields that, at each point, vary sinusoidally in time with a single temporal fr ...
sensor. The goal is to achieve a more optically perfect eye, though the result still depends on the physician's success at predicting changes that occur during healing and other factors that may have to do with the regularity/irregularity of the cornea and the axis of any residual astigmatism. Another important factor is whether the excimer laser can correctly register eye position in 3 dimensions, and to track the eye in all the possible directions of eye movement. If a wavefront guided treatment is performed with less than perfect registration and tracking, pre-existing aberrations can be worsened. In older patients, scattering from microscopic particles (
cataract A cataract is a cloudy area in the lens of the eye that leads to a decrease in vision. Cataracts often develop slowly and can affect one or both eyes. Symptoms may include faded colors, blurry or double vision, halos around light, trouble ...
or incipient cataract) may play a role that outweighs any benefit from wavefront correction.Walsh MJ. Is the future of refractive surgery based on corneal topography or wavefront? "Ocular Surgery News". August 1, 2000, page 26.Walsh MJ. Wavefront is showing signs of success, but can it do it alone? ''Ocular Surgery News''. September 1, 2000, page 41.EW Dialogue: the future of wavefront refraction as a diagnostic tool. "EyeWorld". May 2000, pages 64 and 65. When treating a patient with preexisting astigmatism, most wavefront-guided LASIK lasers are designed to treat regular astigmatism as determined externally by
corneal topography Corneal topography, also known as photokeratoscopy or videokeratography, is a non-invasive medical imaging technique for mapping the anterior curvature of the cornea, the outer structure of the eye. Since the cornea is normally responsible for s ...
. In patients who have an element of internally induced astigmatism, therefore, the wavefront-guided astigmatism correction may leave regular astigmatism behind (a cross-cylinder effect). If the patient has preexisting irregular astigmatism, wavefront-guided approaches may leave both regular and irregular astigmatism behind. This can result in less-than-optimal visual acuity compared with a wavefront-guided approach combined with vector planning, as shown in a 2008 study. Thus, vector-planning offers a better alignment between corneal astigmatism and laser treatment, and leaves less regular astigmatism behind on the cornea, which is advantageous whether irregular astigmatism coexists or not. The "leftover" astigmatism after a purely surface-guided laser correction can be calculated beforehand, and is called ocular residual astigmatism (ORA). ORA is a calculation of astigmatism due to the noncorneal surface (internal) optics. The purely refraction-based approach represented by wavefront analysis actually conflicts with corneal surgical experience developed over many years. The pathway to "super vision" thus may require a more customized approach to corneal astigmatism than is usually attempted, and any remaining astigmatism ought to be regular (as opposed to irregular), which are both fundamental principles of vector planning overlooked by a purely wavefront-guided treatment plan. This was confirmed by the 2008 study mentioned above, which found a greater reduction in corneal astigmatism and better visual outcomes under mesopic conditions using wavefront technology combined with vector analysis than using wavefront technology alone, and also found equivalent higher-order aberrations (see below). Vector planning also proved advantageous in patients with keratoconus. No good data can be found that compare the percentage of LASIK procedures that employ wavefront guidance versus the percentage that do not, nor the percentage of refractive surgeons who have a preference one way or the other. Wavefront technology continues to be positioned as an "advance" in LASIK with putative advantages;American Academy of Ophthalmology
"''Refractive Laser Surgery: An In-Depth Look at LASIK and Brief Overview of PRK, Epi-LASIK, and LASEK: A Science Writer's Guide''"
. Accessed January 29, 2012.
Abbott Medical Optics website
"WaveScan WaveFront System"
Accessed August 15, 2012.
Emory Healthcare website

Accessed August 15, 2012.
Croes K. AllAboutVision website

Accessed August 15, 2012.
however, it is clear that not all LASIK procedures are performed with wavefront guidance. Still, surgeons claim patients are generally more satisfied with this technique than with previous methods, particularly regarding lowered incidence of "halos," the visual artifact caused by spherical aberration induced in the eye by earlier methods. A meta-analysis of eight trials showed a lower incidence of these higher order aberrations in patients who had wavefront-guided LASIK compared to non-wavefront-guided LASIK. Based on their experience, the United States Air Force has described WFG-Lasik as giving "superior vision results".


Topography-assisted

Topography-assisted LASIK is intended to be an advancement in precision and reduce night-vision side effects. The first topography-assisted device received FDA approval September 13, 2013.


History


Barraquer's early work

In the 1950s, the
microkeratome A microkeratome is a precision surgical instrument with an oscillating blade designed for creating the corneal flap in LASIK or ALK surgery. The normal human cornea varies from around 500 to 600 micrometres in thickness; and in the LASIK procedur ...
and keratomileusis technique were developed in Bogotá, Colombia, by the
Spanish Spanish might refer to: * Items from or related to Spain: **Spaniards are a nation and ethnic group indigenous to Spain **Spanish language, spoken in Spain and many Latin American countries **Spanish cuisine Other places * Spanish, Ontario, Can ...
ophthalmologist
Jose Barraquer José Ignacio Barraquer Moner (24 January 1916 – 13 February 1998) was a Spanish ophthalmologist and inventor born in Barcelona who did most of his life's work in Bogotá, Colombia. His original pioneering investigations on corneal transp ...
. In his clinic, he would cut thin (one hundredth of a mm thick) flaps in the
cornea The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber. Along with the anterior chamber and lens, the cornea refracts light, accounting for approximately two-thirds of the eye's total optical ...
to alter its shape. Barraquer also investigated how much of the cornea had to be left unaltered in order to provide stable long-term results. This work was followed by that of the Russian scientist,
Svyatoslav Fyodorov Svyatoslav Nikolayevich Fyodorov (; August 8, 1927 – June 2, 2000) was a Russian ophthalmologist, politician, professor, full member of the Russian Academy of Sciences and Russian Academy of Medical Sciences. He is considered to be a pioneer o ...
, who developed radial keratotomy (RK) in the 1970s and designed the first posterior chamber implantable contact lenses (
phakic intraocular lens A phakic intraocular lens (PIOL) is a special kind of intraocular lens that is implanted surgically into the eye to correct myopia (nearsightedness). It is called "phakic" (meaning "having a lens") because the eye's natural lens is left untouched. ...
) in the 1980s.


Laser refractive surgery

In 1980, Rangaswamy Srinivasan, Samuel E. Blum and James J. Wynne at the
IBM Research IBM Research is the research and development division for IBM, an American multinational information technology company headquartered in Armonk, New York, with operations in over 170 countries. IBM Research is the largest industrial research or ...
laboratory, discovered that an ultraviolet excimer laser could etch living tissue, with precision and with no thermal damage to the surrounding area. The phenomenon was termed "ablative photo-decomposition" (APD). Five years later, in 1985, Steven Trokel at the Edward S. Harkness Eye Institute,
Columbia University Columbia University (also known as Columbia, and officially as Columbia University in the City of New York) is a private research university in New York City. Established in 1754 as King's College on the grounds of Trinity Church in Manhatt ...
in New York City, published his work using the excimer laser in radial keratotomy. He wrote, :"The central corneal flattening obtained by radial diamond knife incisions has been duplicated by radial laser incisions in 18 enucleated human eyes. The incisions, made by 193 nm far-ultraviolet light radiation emitted by the excimer laser, produced corneal flattening ranging from 0.12 to 5.35 diopters. Both the depth of the corneal incisions and the degree of central corneal flattening correlated with the laser energy applied. Histopathology revealed the remarkably smooth edges of the laser incisions." Together with his colleagues, Charles Munnerlyn and Terry Clapham, Trokel founded VISX USA inc. Marguerite B. MacDonald MD performed the first human VISX refractive laser eye surgery in 1989.


Patent

A number of patents have been issued for several techniques related to LASIK. Rangaswamy Srinivasan and James Wynne filed a patent application on the
ultraviolet Ultraviolet (UV) is a form of electromagnetic radiation with wavelength from 10 nm (with a corresponding frequency around 30  PHz) to 400 nm (750  THz), shorter than that of visible light, but longer than X-rays. UV radiation ...
excimer laser, in 1986, issued in 1988. In 1989, Gholam A. Peyman was granted a US patent for using an excimer laser to modify corneal curvature. It was, :"A method and apparatus for modifying the curvature of a live cornea via use of an excimer laser. The live cornea has a thin layer removed therefrom, leaving an exposed internal surface thereon. Then, either the surface or thin layer is exposed to the laser beam along a predetermined pattern to ablate desired portions. The thin layer is then replaced onto the surface. Ablating a central area of the surface or thin layer makes the cornea less curved, while ablating an annular area spaced from the center of the surface or layer makes the cornea more curved. The desired predetermined pattern is formed by use of a variable diaphragm, a rotating orifice of variable size, a movable mirror or a movable fiber optic cable through which the laser beam is directed towards the exposed internal surface or removed thin layer." The patents related to so-called broad-beam LASIK and PRK technologies were granted to US companies including Visx and Summit during 1990–1995 based on the fundamental US patent issued to IBM (1988) which claimed the use of UV laser for the ablation of organic tissues.


Implementation in the U.S.

The LASIK technique was implemented in the U.S. after its successful application elsewhere. The
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA) commenced a trial of the excimer laser in 1989. The first enterprise to receive FDA approval to use an excimer laser for photo-refractive keratectomy was Summit Technology (founder and CEO, Dr. David Muller). In 1992, under the direction of the FDA, Greek ophthalmologist Ioannis Pallikaris introduced LASIK to ten VISX centers. In 1998, the "Kremer Excimer Laser", serial number KEA 940202, received FDA approval for its singular use for performing LASIK. Subsequently, Summit Technology was the first company to receive FDA approval to mass manufacture and distribute excimer lasers. VISX and other companies followed. Pallikaris suggested a flap of cornea could be raised by microkeratome prior to the performing of PRK with the excimer laser. The addition of a flap to PRK became known as LASIK.


Recent years

The procedure seems to be a declining option for many in the United States, dropping more than 50 percent, from about 1.5 million surgeries in 2007 to 604,000 in 2015, according to the eye-care data source Market Scope. A study in the journal ''Cornea'' determined the frequency with which LASIK was searched on Google from 2007 to 2011. Within this time frame, LASIK searches declined by 40% in the United States. Countries such as the U.K. and India also showed a decline, 22% and 24% respectively. Canada, however, showed an increase in LASIK searches by 8%. This decrease in interest can be attributed to several factors: the emergence of refractive cataract surgery, the economic recession in 2008, and unfavorable media coverage from the FDA's 2008 press release on LASIK.


Effectiveness

In 2006, the British
National Health Service The National Health Service (NHS) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Since 1948, they have been funded out of general taxation. There are three systems which are referred to using the " ...
's
National Institute for Health and Clinical Excellence The National Institute for Health and Care Excellence (NICE) is an executive non-departmental public body of the Department of Health and Social Care in England that publishes guidelines in four areas: * the use of health technologies withi ...
(NICE) considered evidence of the effectiveness and the potential risks of the laser surgery stating "current evidence suggests that photorefractive (laser) surgery for the correction of refractive errors is safe and effective for use in appropriately selected patients. Clinicians undertaking photorefractive (laser) surgery for the correction of refractive errors should ensure that patients understand the benefits and potential risks of the procedure. Risks include failure to achieve the expected improvement in unaided vision, development of new visual disturbances, corneal infection and flap complications. These risks should be weighed against those of wearing spectacles or contact lenses." The FDA reports "The safety and effectiveness of refractive procedures has not been determined in patients with some diseases."


Satisfaction

Surveys of LASIK surgery find rates of patient satisfaction between 92 and 98 percent. In March 2008, the American Society of Cataract and Refractive Surgery published a patient satisfaction meta-analysis of over 3,000 peer-reviewed articles from international clinical journals. Data from a systematic literature review conducted from 1988 to 2008, consisting of 309 peer-reviewed articles about "properly conducted, well-designed, randomized clinical trials" found a 95.4 percent patient satisfaction rate among LASIK patients. A 2017 JAMA study claims that overall, preoperative symptoms decreased significantly, and visual acuity excelled. A meta-analysis discovered that 97% of patients achieved uncorrected visual acuity (UCVA) of 20/40, while 62% achieved 20/20. The increase in visual acuity allows individuals to enter occupations that were previously not an option due to their vision.


Dissatisfaction

Some people with poor outcomes from LASIK surgical procedures report a significantly reduced
quality of life Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards ...
because of vision problems or pain associated with the surgery. A small percentage of patients may need further surgery because their condition is over- or under-corrected. Some patients need to wear contact lenses or glasses even after treatment. The most common reason for dissatisfaction in LASIK patients is chronic severe
dry eye Dry or dryness most often refers to: * Lack of rainfall, which may refer to **Arid regions **Drought * Dry or dry area, relating to legal prohibition of selling, serving, or imbibing alcoholic beverages * Dry humor, deadpan * Dryness (medical) * ...
. Independent research indicates 95% of patients experience dry eye in the initial post-operative period. This number has been reported to up to 60% after one month. Symptoms begin to improve in the vast majority of patients in the 6 to 12 months following the surgery. However, 30% of post-LASIK referrals to tertiary ophthalmology care centers have been shown to be due to chronic dry eye. Morris Waxler, a former FDA official who was involved in the approval of LASIK, subsequently criticized its widespread use. In 2010, Waxler made media appearances and claimed that the procedure had a failure rate greater than 50%. The FDA responded that Waxler's information was "filled with false statements, incorrect citations" and "mischaracterization of results". A 2016 JAMA study indicates that the prevalence of complications from LASIK are higher than indicated, with the study indicating many patients experience glare, halos or other visual symptoms. Forty-three percent of participants in a JAMA study (published in 2017) reported new visual symptoms they had not experienced before.


Presbyopia

A type of LASIK, known as presbyLasik, may be used in
presbyopia Presbyopia is physiological insufficiency of accommodation associated with the aging of the eye that results in progressively worsening ability to focus clearly on close objects. Also known as age-related farsightedness (or age-related long si ...
. Results are, however, more variable and some people have a decrease in
visual acuity Visual acuity (VA) commonly refers to the clarity of vision, but technically rates an examinee's ability to recognize small details with precision. Visual acuity is dependent on optical and neural factors, i.e. (1) the sharpness of the retinal ...
.


Risks


Higher-order aberrations

Higher-order aberrations are visual problems that require special testing for diagnosis and are not corrected with normal spectacles (eyeglasses). These aberrations include 'starbursts', 'ghosting', 'halos' and others. Some patients describe these symptoms post-operatively and associate them with the LASIK technique including the formation of the flap and the tissue ablation. There is a correlation between pupil size and aberrations. This correlation may be the result of irregularity in the corneal tissue between the untouched part of the cornea and the reshaped part. Daytime post-LASIK vision is optimal, since the pupil size is smaller than the LASIK flap. Others propose that higher-order aberrations are present preoperatively. They can be measured in micrometers (µm) whereas the smallest laser-beam size approved by the
FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
is about 1000 times larger, at 0.65 mm. In situ keratomileusis effected at a later age increases the incidence of corneal higher-order wavefront aberrations. These factors demonstrate the importance of careful patient selection for LASIK treatment.


Dry eyes

95% of patients report dry-eye symptoms after LASIK. Although it is usually temporary, it can develop into chronic and severe
dry eye syndrome Dry eye syndrome (DES), also known as keratoconjunctivitis sicca (KCS), is the condition of having dry eyes. Other associated symptoms include irritation, redness, discharge, and easily fatigued eyes. Blurred vision may also occur. Symptoms range ...
. Quality of life can be severely affected by dry-eye syndrome. Underlying conditions with dry eye such as Sjögren's syndrome are considered contraindications to Lasik. Treatments include artificial tears, prescription tears, and punctal occlusion. Punctal occlusion is accomplished by placing a collagen or silicone plug in the
tear duct The nasolacrimal duct (also called the tear duct) carries tears from the lacrimal sac of the eye into the nasal cavity. The duct begins in the eye socket between the maxillary and lacrimal bones, from where it passes downwards and backwards. The ...
, which normally drains fluid from the eye. Some patients complain of ongoing dry-eye symptoms despite such treatments and the symptoms may be permanent.


Halos

Some post-LASIK patients see halos and starbursts around bright lights at night. At night, the pupil may dilate to be larger than the flap leading to the edge of the flap or stromal changes causing visual distortion of light that does not occur during the day when the pupil is smaller. The eyes can be examined for large pupils pre-operatively and the risk of this symptom assessed. Complications due to LASIK have been classified as those that occur due to preoperative, intraoperative, early postoperative, or late postoperative sources:Majmudar, PA
"LASIK Complications."
''Focal Points: Clinical Modules for Ophthalmologists.'' American Academy of Ophthalmology. September, 2004.
According to the UK
National Health Service The National Health Service (NHS) is the umbrella term for the publicly funded healthcare systems of the United Kingdom (UK). Since 1948, they have been funded out of general taxation. There are three systems which are referred to using the " ...
, complications occur in fewer than 5% of cases.


Other complications

* Flap complications – The incidence of flap complications is about 0.244%. Flap complications (such as displaced flaps or folds in the flaps that necessitate repositioning, diffuse lamellar keratitis, and epithelial ingrowth) are common in lamellar corneal surgeries but rarely lead to permanent loss of visual acuity. The incidence of these microkeratome-related complications decreases with increased physician experience. * Slipped flap – is a corneal flap that detaches from the rest of the cornea. The chances of this are greatest immediately after surgery, so patients typically are advised to go home and sleep to let the flap adhere and heal. Patients are usually given sleep goggles or eye shields to wear for several nights to prevent them from dislodging the flap in their sleep. A short operation time may decrease the chance of this complication, as there is less time for the flap to dry. * Flap interface particles – are a finding whose clinical significance is undetermined. Particles of various sizes and reflectivity are clinically visible in about 38.7% of eyes examined via
slit lamp A slit lamp is an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye. It is used in conjunction with a biomicroscope. The lamp facilitates an examination of the anterior segme ...
biomicroscopy and in 100% of eyes examined by
confocal microscopy Confocal microscopy, most frequently confocal laser scanning microscopy (CLSM) or laser confocal scanning microscopy (LCSM), is an optical imaging technique for increasing optical resolution and contrast of a micrograph by means of using a s ...
. * Diffuse lamellar keratitis  – an inflammatory process that involves an accumulation of white blood cells at the interface between the LASIK corneal flap and the underlying stroma. It is known colloquially as "sands of Sahara syndrome" because on slit lamp exam, the inflammatory infiltrate appears similar to waves of sand. The USAeyes organisation reports an incidence of 2.3% after LASIK. It is most commonly treated with steroid eye drops. Sometimes it is necessary for the eye surgeon to lift the flap and manually remove the accumulated cells. DLK has not been reported with photorefractive keratectomy due to the absence of flap creation. * Infection – the incidence of infection responsive to treatment has been estimated at 0.04%. * Post-LASIK corneal ectasia – a condition where the cornea starts to bulge forwards at a variable time after LASIK, causing irregular astigmatism. the condition is similar to keratoconus. * Subconjunctival hemorrhage – A report shows the incidence of
subconjunctival hemorrhage Subconjunctival bleeding, also known as subconjunctival hemorrhage or subconjunctival haemorrhage, is bleeding from a small blood vessel over the whites of the eye. It results in a red spot in the white of the eye. There is generally little to no ...
has been estimated at 10.5%. * Corneal scarring – or permanent problems with cornea's shape making it impossible to wear contact lenses. * Epithelial ingrowth – estimated at 0.01%. * Traumatic flap dislocations – Cases of late traumatic flap dislocations have been reported up to thirteen years after LASIK. * Retinal detachment: estimated at 0.36 percent. *
Choroidal neovascularization Choroidal neovascularization (CNV) is the creation of new blood vessels in the choroid layer of the eye. Choroidal neovascularization is a common cause of neovascular degenerative maculopathy (i.e. 'wet' macular degeneration) commonly exacerbated ...
: estimated at 0.33 percent. *
Uveitis Uveitis () is inflammation of the uvea, the pigmented layer of the eye between the inner retina and the outer fibrous layer composed of the sclera and cornea. The uvea consists of the middle layer of pigmented vascular structures of the eye and in ...
: estimated at 0.18 percent. * For climbers – Although the cornea usually is thinner after LASIK, because of the removal of part of the stroma, refractive surgeons strive to maintain the maximum thickness to avoid structurally weakening the cornea. Decreased atmospheric pressure at higher altitudes has not been demonstrated as extremely dangerous to the eyes of LASIK patients. However, some
mountain climber Mountaineering or alpinism, is a set of outdoor activities that involves ascending tall mountains. Mountaineering-related activities include traditional outdoor climbing, skiing, and traversing via ferratas. Indoor climbing, sport climbing, an ...
s have experienced a myopic shift at extreme altitudes. * Late postoperative complications – A large body of evidence on the chances of long-term complications is not yet established and may be changing due to advances in operator experience, instruments and techniques. * Potential best vision loss may occur a year after the surgery regardless of the use of eyewear. * Ocular neuropathic pain (corneal neuralgia); rare


FDA's position

In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK in response to widespread reports of problems experienced by patients after LASIK laser eye surgery. This project examined patient-reported outcomes with LASIK (PROWL). The project consisted of three phases: pilot phase, phase I, phase II (PROWL-1) and phase III (PROWL-2). The last two phases were completed in 2014. The results of the LASIK Quality of Life Study were published in October 2014. The FDA's director of the Division of Ophthalmic Devices, said about the LASIK study "Given the large number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may occur in a significant number of patients". Also in 2014, FDA published an article highlighting the risks and a list of factors and conditions individuals should consider when choosing a doctor for their refractive surgery.


Contraindications

Not everyone is eligible to receive LASIK. Severe keratoconus or thin corneas may disqualify patients from LASIK, though other procedures may be viable options. Those with Fuchs' corneal endothelial dystrophy, corneal epithelial basement membrane dystrophy, retinal tears, autoimmune diseases, severe dry eyes, and significant blepharitis should be treated before consideration for LASIK. Women who are pregnant or nursing are generally not eligible to undergo LASIK. People with large pupils (e.g. due to taking medications or in the younger age group) may be particularly prone to symptoms such as glare, halos, starbursts, and ghost images (double vision) in dim light after surgery. Because the laser can only work on the inner section of the cornea, the outer rim is left unaffected. In dim lighting, a patient's pupils dilate and may be predisposed to optic aberrations due to refractive asynchrony of the two regions with regards to the incoming light.


Further research

Since 1991, there have been further developments such as faster lasers; larger spot areas; bladeless flap incisions; intraoperative
corneal pachymetry Corneal pachymetry is the process of measuring the thickness of the cornea. A pachymeter is a medical device used to measure the thickness of the eye's cornea. It is used to perform corneal pachymetry prior to refractive surgery, for Keratoconus ...
; and "wavefront-optimized" and "wavefront-guided" techniques which were introduced by the University of Michigan's Center for Ultrafast Optical Science. The goal of replacing standard LASIK in refractive surgery is to avoid permanently weakening the cornea with incisions and to deliver less energy to the surrounding tissues. More recently, techniques like Epi-Bowman Keratectomy have been developed that avoid touching the epithelial basement membrane or Bowman's layer.


Experimental techniques

* "plain" LASIK: LASEK, Epi-LASIK, * Wavefront-guided PRK, * advanced
intraocular lens Intraocular lens (IOL) is a lens (optics), lens implanted in the human eye, eye as part of a treatment for cataracts or myopia. If the natural lens is left in the eye, the IOL is known as Phakic intraocular lens, phakic, otherwise it is a pseudop ...
es. * Femtosecond laser intrastromal vision correction: using all-femtosecond correction, for example, Femtosecond Lenticule EXtraction, FLIVC, or IntraCOR), * Keraflex: a thermobiochemical solution which has received the
CE Mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ...
for refractive correction. and is in European clinical trials for the correction of myopia and keratoconus. * Technolas FEMTEC laser: for incisionless IntraCOR ablation for presbyopia, with trials ongoing for myopia and other conditions. * LASIK with the IntraLase femtosecond laser: early trials comparing to the LASIK with microkeratomes for the correction of myopia suggest no significant differences in safety or efficacy. However, the femtosecond laser has a potential advantage in predictability, although this finding was not significant».


Comparison to photorefractive keratectomy

A systematic review that compared PRK and LASIK concluded that LASIK has shorter recovery time and less pain. The two techniques after a period of one year have similar results. A 2017 systematic review found uncertainty in visual acuity, but found that in one study, those receiving PRK were less likely to achieve a refractive error, and were less likely to have an over-correction than compared to LASIK.


References


External links


What is LASIK?
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

Laser Eye Surgery
United States National Library of Medicine The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library. Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. Its ...
{{Authority control 1989 introductions