Refractive surgery is surgery performed on the eye to create
a better focus and lesser dependence on glasses and contact
lenses. In recent years the field has expanded to include operations
for all types of refractive errors: myopia, hyperopia, astigmatism
and presbyopia. The recent increase in popularity of refractive
surgery is directly related to its success in producing effective
and predictable visual improvement without significant side
effects.
Strictly speaking, refractive surgery might also include procedures
which have a refractive impact, e.g., cataract extraction and
corneal transplantation, both of which signficantly affect
the refractive error of the involved eye. However, this effect
is mostly secondary to the actual purpose of the surgery, which
is usually to eliminate an opacification in the normally clear
line of vision. Therefore, this discussion will be limited
to those procedures which possess the primary intent
of lessening the refractive error of the eye.
The history of refractive surgery has its early roots in claims
in the mid 1800s to eliminate glasses by flattening the cornea
with a spring-mounted mallet through the closed eyelid. However,
it was a hundred years later before serious surgical investigation
was begun.
INCISIONAL
SURGERY / RK
- The basic principles of keratotomy were specified by L.J.
Lans, of The Netherlands in 1898; these concepts were extended
to the clinical arena in 1940s and 1950s by T. Sato and K.
Akiyam of Japan, who placed both transverse and radial incision
in the posterior surface of the cornea.Their surgery caused
the central part of the cornea to flatten, thereby correcting
myopia. They correctly observed that the amount of correction
in vision was directly related to the number, length and
depth of the incisions.
- In the 1960s in the USSR, S. Fyodorov significantly increased
the safety of what was now called Radial Keratotomy (RK)
by placing the multiple incisions on the anterior surface
of the eye and leaving a clear central optical zone. He observed
that predictable results could be obtained by using steel
surgical blades and a standardized formula of correction.
Interest in Radial Keratotomy spread to the United States
in the late 1970s prompting the nationwide PERK study sanctioned
by the National Eye Institute. Results of this study demonstrated
the effectiveness of RK but also noted a disturbing percentage
of patients with progressive surgical effect and fluctuating
daily vision.
- Improvements in RK surgical technology by the use of ultrathin
diamond micrometer cutting blades, microscopic guidance systems
and computer databases for results tracking and predictive
nomograms helped the procedure to become increasing popular
in the early 1990s after a dropoff in popularity owing to
the results of the PERK study.
LASER
SURGERY / PRK
- During this time research into the use of the excimer laser
was begun by Charles Brau and James Ewing in 1973. The first
excimer laser action was produced by Stuart Searles in 1975;
the first commercial system was created by Tachisto in 1979.
Research into ophthalmology usage was noted by Taboada, Mikesell
and Reed in 1981 who performed procedures on the anterior
corneal surface. In 1983 Stephen Trokel presented a paper
describing the potential of the excimer laser for performing
photorefractive keratectomy (PRK) on humans. The first experiments
were soon after performed by Trokel and R. Srinivasan. Shortly
afterwards in 1985 and 1986 were formed two companies, VISX
and Summit Technology, Inc., which introduced the excimer
laser to the ophthalmology community of the United States.
- In 1987 L'Esperance performed the first PRKin the United
States on a blind eye; a year later, Marguerite McDonald
performed the first PRK in the United States on a normally
sighted person with myopia. The first procedure of phototherapeutic
keratectomy (PTK) was performed by Theo Seiler of Germany
in 1985.
- After a series of clinical studies, the United States FDA
finally approved the use of the Summit laser for PRK correction
of myopia in 1995; approval for the VISX laser was granted
later in 1996. A year later, the FDA approved the use of
the VISX laser for the correction of myopic astigmatism.The
Food and Drug Administration of the United States approved
the excimer laser for Photorefractive Keratectomy (PRK) in
October, 1995, for the purpose of correcting nearsightedness.
The procedure of PRK reshapes the human cornea by application
of laser energy to its front surface, producing a flattening
effect. Approval was based on clinical trials of more than
1600 eyes followed for three years. Additional consideration
was given to studies from Canada and Europe, where the procedure
has been performed since 1987
The report responsible for FDA approval of PRK in the
United States utilized a 6.0 mm central treatment zone.
The multicenter studies involved 398 eyes in 300 patients.
The mean attempted correction was -4.23 D with range
of -1.50 D to -7.80 D. Twelve months after the procedure,
98.8% of eyes treated had 20/40 or better uncorrected
visual acuity; 80.5% of eyes saw 20/20 or better. Vision
was stable (as opposed to RK.) The only adverse effects
were minimal symptoms of halos and glare in 2.4% of eyes
and a loss of best corrected visual acuity of two lines
in 1.2% of eyes. (Note: it is likely that these minimal
adverse effects will disappear when the 18 month point
is reached.)
The approval was recognized by the American
Society of Cataract and Refractive Surgery and
the International Society for Refractive Surgery which
offers its members instruction and information regarding
this and other evolving refractive surgical corrective
techniques. The American Academy of Ophthalmology has now certified
PRK as being safe and effective in correcting low and
moderate levels of myopia.
LASER
SURGERY / LASIK
- The concept of LASIK refractive surgery involves the placement
of an incision into the cornea to create a hinged flap which
can then be lifted up to expose the underlying corneal stroma
which can be partially ablated with the excimer laser. The
origins of this procedure begin with Jose Barraquer who founded
the operation of Keratomileusis in the 1970s by which a thin
corneal wafer was removed, reshaped with a cryolathe, and
then reinserted into the cornea. Automated Lamellar Keratectomy
as created by Luis A. Ruiz in the 1982 took this concept
further by using an automated device called a microkeratome,
or corneal shaper, to excise an internal disc of corneal
tissue allowing treatment of myopic refractive errors up
to -20 diopters.
- LASIK was originally described in 1989 by Pillikaris of
Greece who used the excimer laser to treat the underlying
stromal bed beneath a corneal flap which he had created with
a microkeratome; a year later, Buratto of Italy used the
same technique to successfully treat the undersurface of
the corneal flap. The operation of LASIK became increasingly
popular worldwide as its predictabiliy became enhanced and
the lack of pain and rapid improvement in vision fueled consumer
demand. In 1997, the FDA of the United States deemed the
procedure to be 'off label' and thereby permissible to be
performed by any licensed physician. After prolonged investigation
into its safety and effectiveness, the FDA approved LASIK
as a medical procedure in 1999. It is estimated that LASIK
accounts more than 98% of all refractive surgical procedures
worldwide.
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