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LASIK

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For the article on the drug used for treatment of hypertension, see Lasix.

LASIK
Intervention
LASIK surgery using a excimer laser at US National
Naval Medical Center Bethesda
ICD-9-CM
11.71
MeSH
D020731
MedlinePlus
007018
[edit on Wikidata]
LASIK or Lasik (laser-assisted in situ keratomileusis), commonly referred to as laser eye
surgery or laser vision correction, is a type of refractive surgery for the correction of myopia,
hyperopia, and astigmatism. The LASIK surgery is performed by an ophthalmologist who uses a
laser or microkeratome to reshape the eye's cornea in order to improve visual acuity.[1] For most
patients, LASIK provides a permanent alternative to eyeglasses or contact lenses.[2]
LASIK is most similar to another surgical corrective procedure, photorefractive keratectomy
(PRK), and both represent advances over radial keratotomy in the surgical treatment of refractive
errors of vision. For patients with moderate to high myopia or thin corneas which cannot be
treated with LASIK and PRK, the phakic intraocular lens is an alternative.[3][4] As of 2011, over
11 million LASIK procedures had been performed in the United States[5] and as of 2009 over 28
million have been performed worldwide.[6]

Contents

1 Effectiveness
o 1.1 Satisfaction
o 1.2 Dissatisfaction
o 1.3 Presbyopia

2 Risks
o 2.1 Vision loss due to infection
o 2.2 Higher-order aberrations

o 2.3 Dry eyes


o 2.4 Halos
o 2.5 Other complications

3 Process
o 3.1 Preoperative procedures
o 3.2 Operative procedure
o 3.3 Postoperative care

4 Wavefront-guided

5 Topography-assisted

6 History
o 6.1 Barraquer's early work
o 6.2 Laser refractive surgery
o 6.3 Patent
o 6.4 Implementation in U.S.

7 Further research
o 7.1 Experimental techniques

8 Comparison to photorefractive keratectomy

9 FDA's position
o 9.1 Quality of life study

10 References

11 External links

Effectiveness

In 2006, the British National Health Service's National Institute for Health and Clinical
Excellence (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 efficacious 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."[7] The FDA reports "The safety and effectiveness of refractive
procedures has not been determined in patients with some diseases."[8]

Satisfaction
Surveys of LASIK find rates of patient satisfaction between 92 and 98 percent.[9][10][11] 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
the prior 10 years revealed a 95.4 percent patient satisfaction rate among LASIK patients.[12]

Dissatisfaction
Some people with poor outcomes from LASIK surgical procedures report a significantly reduced
quality of life because of vision problems or physical pain associated with the surgery. A small
percentage of patients may need to have another surgery because their condition is overcorrected or under-corrected. Some patients need to wear contact lenses or glasses even after
treatment.[13]
In 1999, "Surgical Eyes" was founded in New York City as a resource for patients with
complications of LASIK and other refractive surgeries by RK patient Ron Link. "Surgical Eyes"
has since been superseded by the "Vision Surgery Rehab Network" (VSRN).[14][15][16][17][18]
Morris Waxler, a former FDA official who was involved in the approval of LASIK, has
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".[19]

Presbyopia
A type of LASIK, known as presbyLasik, may be used in presbyopia. Results are, however, more
variable and some people have a decrease in visual acuity.[20]

Risks
Vision loss due to infection

On October 10, 2006, WebMD[21] reported on a peer-reviewed study in the Archives of


Ophthalmology[22] in which statistical analysis revealed that vision loss risk as a result of an
infection for contact lens wearers is higher than vision loss risk as a result of an infection from
LASIK. Daily contact lens wearers have a 1-in-2,000 chance of significant vision loss. The
researchers calculated the risk of significant vision loss consequence of LASIK surgery to be
closer to 1-in-10,000 cases.

Higher-order aberrations
The term "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.[23] Some patients describe these symptoms post-operatively and
associate them with the LASIK technique including the formation of the flap and the tissue
ablation.[24] The advancement of the LASIK technology has reduced the risk of clinically
significant visual impairment after surgery.[citation needed] 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. However, at night, the pupil may dilate such
that light passes through the edge of the LASIK flap which gives rise to aberrations. LASIK and
PRK may induce spherical aberration if the laser under corrects as it moves outward from the
centre of the treatment zone, especially when major corrections are made.[citation needed] Others
propose that higher order aberrations are present preoperatively.[25] They can be measured in
micrometers (m) whereas the smallest laser beam size approved by the FDA 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.[26][27] These factors demonstrate the importance of
careful patient selection for LASIK treatment.

A subconjunctival hemorrhage is a common and minor post-LASIK complication.

Dry eyes
Some people experience dry eyes following surgery.[28] Although it is usually temporary it can
develop into dry eye syndrome.[29]
Underlying conditions with dry eye such as Sjgren's syndrome are considered contraindications
to Lasik.[30]

Treatments include artificial tears, prescription tears and punctal occlusion. Punctal occlusion is
accomplished by placing a collagen or silicone plug in the tear duct, which normally drains fluid
from the eye. Some patients complain of ongoing dry eye symptoms despite such treatments and
dry eye symptoms may be permanent.[31]

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:[32] According to the UK
National Health Service complications occur in fewer than 5% of cases.[28]

Other complications

flap complications The incidence of flap complications is about 0.244%.[33] 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[34] but rarely lead to permanent loss of visual acuity. The incidence of these
microkeratome-related complications decreases with increased physician experience.[35]

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.[citation needed]

Flap interface particles are a finding whose clinical significance is undetermined.[36]


Particles of various sizes and reflectivity are clinically visible in about 38.7% of eyes
examined via slit lamp biomicroscopy and in 100% of eyes examined by confocal
microscopy.[36]

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.[37] 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 0.4%.
[37]

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 has been estimated at 10.5%.[37][38]

Corneal scarring or permanent problems with cornea's shape making it impossible to


wear contact lenses.[13]

epithelial ingrowth estimated at 0.1%.[37]

traumatic flap dislocations Cases of late traumatic flap dislocations have been reported
up to seven years after LASIK.[39]

Retinal detachment: estimated at 0.36 percent.[40]

Choroidal neovascularization: estimated at 0.33 percent.[40]

Uveitis: estimated at 0.18 percent.[41]

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 climbers have experienced a myopic shift at extreme
altitudes.[42][43]

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.[44][45][46][47]

Potential best vision loss a year after the surgery regardless of use of glasses[48]

Process

Play media
Video of a complete LASIK-treatment
The planning and analysis of corneal 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."[49]
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 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 from the tear film. Thus, low-oxygen-permeable contact lenses
reduce the cornea's oxygen absorption, sometimes resulting in corneal neovascularizationthe
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 and over. 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 corneas are examined with a pachymeter to determine their thickness, and

with a topographer, or corneal topography machine,[1] to measure their surface contour. Using
low-power lasers, a topographer creates a topographic map of the cornea. The procedure is
contraindicated if the topographer finds difficulties such as keratoconus[1] The preparatory
process also detects astigmatism 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.[50]

Operative procedure
Flap creation

Flap creation with femtosecond laser


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 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 and
Bowman's layer. This process is achieved with a mechanical microkeratome 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 remodelling
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 micrometres 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 (PRK).[51]
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 (mJ) of pulse energy in 10 to 20
nanoseconds.[52]
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 34
days. Patients should be adequately informed by their surgeons of the importance of proper postoperative care to minimize the risk of complications.[53]

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 sensor. The goal is to
achieve a more optically perfect eye, though the final 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 or incipient
cataract) may play a role that outweighs any benefit from wavefront correction. Therefore,
patients expecting so-called "super vision" from such procedures may be disappointed.[54][55][56][57]
When treating a patient with preexisting astigmatism, most wavefront-guided LASIK lasers are
designed to treat regular astigmatism as determined externally by corneal topography. 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.[58] 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.[57]
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.[57] 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).[58]
Vector planning also proved advantageous in patients with keratoconus.[59]
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;[60][61][62][63] however, it is clear that not all
LASIK procedures are performed with wavefront guidance.[64]
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.[65] Based on their experience, the United States Air
Force has described WFG-Lasik as giving "superior vision results".[66]

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.[67][68]

History
Barraquer's early work

In the 1950s, the microkeratome and keratomileusis technique were developed in Bogot,
Colombia, by the Spanish ophthalmologist Jose Barraquer. In his clinic, he would cut thin (one
hundredth of a mm thick) flaps in the cornea 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.[69] This
work was followed by that of the Russian scientist, Svyatoslav Fyodorov, who developed radial
keratotomy (RK) in the 1970s and designed the first posterior chamber implantable contact
lenses (phakic intraocular lens) in the 1980s.

Laser refractive surgery


In 1980, Rangaswamy Srinivasan, at the IBM Research laboratory, discovered that an ultraviolet
excimer laser could etch living tissue, with precision and with no thermal damage to the
surrounding area. He named the phenomenon "ablative photo-decomposition" (APD).[70] Five
years later, in 1985, Steven Trokel at the Edward S. Harkness Eye Institute, Columbia University
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."[71]
Together with his colleagues, Charles Munnerlyn and Terry Clapham, Trokel founded VISX
USA inc.[72] Marguerite B. MacDonald MD performed the first human VISX refractive laser eye
surgery in 1989.[73]

Patent
A number of patents have been issued for several techniques related to LASIK. Stuart I. Brown
and Josef F. Bille filed a patent on surgical lasers in 1988.[74] Samuel E. Blum, Rangaswamy
Srinivasan and James Wynne filed a patent application on the ultraviolet excimer laser, in 1982,
issued in 1988.[75] In 1989, Gholam A. Peyman was granted a US patent for using an excimer
laser to modify corneal curvature.[76] 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."[75]

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 (1983) which claimed the use of UV laser for the ablation of organic tissues.[75] In
1991, J.T. Lin was granted a US patent (US5520679) for a new technology using a flying-spot
for customized LASIK that has been used worldwide. The first US patent (in 1993) using an eyetracking device to prevent decentration in LASIK procedures was granted to S. Lai.

Implementation in U.S.
The LASIK technique was implemented in the U.S. after its successful application elsewhere.
The Food and Drug Administration (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).[77] In 1992, under the direction of
the FDA, Greek ophthalmologist Ioannis Pallikaris introduced LASIK to ten VISX centres. In
1998, the "Kremer Excimer Laser", serial number KEA 940202, received FDA approval for its
singular use for performing LASIK.[78] Subsequently, Summit Technology was the first company
to receive FDA approval to mass manufacture and distribute excimer lasers. VISX and other
companies followed.[78]

The excimer laser that was used for the first LASIK surgeries by I.Pallikaris
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.

Further research
Since 1991, there have been further developments such as faster lasers; larger spot areas;
bladeless flap incisions; intraoperative corneal pachymetry; and "wavefront-optimized" and
"wavefront-guided" techniques. The goal of refractive surgery is to avoid permanently
weakening the cornea with incisions and to deliver less energy to the surrounding tissues.

Experimental techniques

"plain" LASIK: LASEK, Epi-LASIK,

Sub-Bowmans keratomileusis (thin flap LASIK),

Wavefront-guided PRK,

advanced intraocular lenses.

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 for refractive
correction.[79] and is in European clinical trials for the correction of myopia and
keratoconus.[80]

Technolas FEMTEC laser: for incisionless IntraCOR ablation for presbyopia,[81] with
trials ongoing for myopia and other conditions.[82]

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.[83]

Comparison to photorefractive keratectomy


A systematic review that compared PRK and LASIK concluded that LASIK has shorter recovery
time and less pain.[84] The two techniques after a period of one year have similar results.[84]

FDA's position
On December 6, 2011, the FDA posted a video on the FDA's YouTube channel and the FDA's
LASIK web site to help explain the risks of LASIK and other important information to potential
patients. The video includes images of what certain visual symptoms may look like to patients
experiencing them.[85]

Quality of life study


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[86] in response to
widespread reports of problems experienced by patients after LASIK laser eye surgery.[85] 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).[87] The last
two phases were completed in 2014.
The results of the LASIK Quality of Life Study were published in October, 2014.[86]
Based on our initial analyses of our studies:

Up to 45 percent of participants, who had no visual symptoms before surgery,


reported at least one visual symptom at three months after surgery.

Participants who developed new visual symptoms after surgery, most often
developed halos. Up to 35 percent of participants with no halos before LASIK had
halos three months following surgery.

Up to 30 percent of participants with no symptoms of dry eyes before LASIK,


reported dry eye symptoms at three months after their surgery.

Less than 1 percent of study participants experienced "a lot of" difficulty with or
inability to do usual activities without corrective lenses because of their visual
symptoms (halos, glare, et al.) after LASIK surgery.

Participants who were not satisfied with the LASIK surgery reported all types of
visual symptoms the questionnaire measured (double vision/ghosting, starbursts,
glare, and halos).

At the American Academy of Ophthalmology (AAO) convention in Chicago on October 17,


2014 the FDA's director of the Division of Ophthalmic Devices, ophthalmologist Malvina B.
Eydelman, in conclusion to her presentation about the LASIK study results said: "Given the large
number of patients undergoing LASIK annually, dissatisfaction and disabling symptoms may
occur in a significant number of patients".[88] 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.[89]

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