|
| |
Excimer
Laser Procedures
Photorefractive
keratectomy (PRK), laser assisted in-situ keratomileusis (LASIK) and laser
epithelial keratomileusis (LASEK) currently use
an ultraviolet Argon Fluoride (193nm) gas discharge laser to remove minute
layers of superficial corneal tissue under computer control. The computer
controlling the laser is programmed to generate a specific algorithm
relating to the diameter and depth required for a given refractive change,
based on the average amount of tissue removed per pulse (Munnerlyn et al.,
1988). To treat myopia, more tissue must be removed from the centre of the
cornea than the periphery to produce a flatter refracting surface. The
amount of tissue removed for low myopia is in the region of approximately 50m
m - less than 10% of the overall corneal thickness. The treatment of
astigmatism involves greater ablation of one principle meridian than the
other. Hypermetropic treatments attempt to steepen the optically significant
central cornea by producing a smoothly transitioned annular ablation in the
stroma at the periphery of the optic zone. The central cornea remains either
untouched or just lightly ablated. The ring-shaped ablation zone used for
hyperopic correction has a relatively narrow width and the wound healing
mechanisms post-surgery tend to partially fill in this region causing
regression of the refractive correction.
-
Photorefractive
Keratectomy (PRK)
The first
PRK procedure was performed on a human cornea in November 1989 by Mr.
David Gartry at St Thomas’ hospital. Anaesthetic eye drops are instilled
into the eye and the front layer of the cornea (epithelium) is scraped
away over an area approximately 1mm larger in diameter than the intended
treatment zone (Campos et al., 1992a) to expose Bowman’s membrane
(figure 9).

Figure
9: Remodelled corneal surface following PRK treatment. The zone over which
the corneal epithelium has been removed, can also be visualised. (Courtesy
of Mr David Gartry)
The
excimer laser is then employed to remodel the anterior corneal surface by
the ablation of stromal tissue for a period between 5 and 90 seconds
(figure 11B) (Trokel et al., 1983). The post-operative pain used to
be severe for the first 24 hours but is now well controlled by medication
such as topical non-steroidals and oral analgesia, and the use of bandage
contact lenses. Some pain persists and the vision remains poor until the
epithelium has healed over the treated area after approximately 3-6 days
(McDonald et al., 1991). Eighty-three percent of low myopes (<
-6D) and 61.4% of high myopes (>-6D) achieve the driving standard
unaided (6/12 vision) by the end of the first week post-PRK (Reich et
al., 1996). Unlike radial keratotomy, PRK involves treating the centre
of the cornea therefore changes in corneal clarity are of concern. A
sub-epithelial opacification referred to as haze develops over the first
2-4 weeks (figure 10), peaking in intensity around 2-3 months and
gradually subsiding by approximately 12 months (Gartry et al.,
1992; Gartry et al., 1993; Lohmann et al., 1991; Seiler
et al., 1990; McDonald et al., 1989; McDonald et al.,
1990a; McDonald et al., 1990b; McDonald et al., 1990c).
Surgical
outcomes
As with radial
keratotomy, PRK is more successful for lower degrees of myopia. For low
and medium degrees of myopia (<-6.00D), 88-99% achieve 6/12 or better
(uncorrected vision), and 58-78% achieve 6/6 or better by 12 months post-PRK
(Tuunanen and Tervo, 1998; McDonald et al., 1999; Pallikaris et
al., 1999; Nagy et al., 2002). For higher degrees of myopia
(>-6.00D), 68-74% achieve 6/12 or better (uncorrected vision), with
only around 26% obtaining 6/6 at 12 months. The refractive error tends to
be slightly hyperopic initially, drifting towards emmetropia, or mild
myopia as the cornea heals. By 12 months, 87-99% of low and medium myopes
(<–6.00D), and 79-84% of high myopes are within ±
1D of emmetropia. Enhancement procedures can be performed to correct
residual refractive error but predictability is not as good as for the
initial procedure. PRK is now restricted to the treatment of myopia up to
about –4.00D because it is able to produce highly predictable results
for this group with rapid stabilisation of the refraction in the vast
majority of cases.

Figure
10: Corneal haze post-PRK (courtesy of Mr Sunil
Shah)
The
technique for treating astigmatism using an excimer laser has become
known as Photoastigmatic Refractive Keratectomy (PARK). The results are
less accurate than those for myopic photorefractive keratectomy alone
(see appendix) since the axis alignment is critical (Stevens and Steele,
1993) and there are variations in meridional wound healing with greater
regression occurring in the meridian of greater tissue loss (Shieh et
al., 1992). Shah et al. (Shah et al., 1997) reported that
patients with high cylinders were unlikely to achieve 6/6
unaided and only a limited number achieve 6/12.
The risk of a loss of best-corrected visual acuity is also slightly
greater (Higa et al., 1997).
As with
myopia treatment, hyperopic PRK is more predictable for lower refractive
errors (<+3.50D) (Daya et al., 1997; Knorz et al.,
1998), however, stabilisation of the refractive error can take up to 12
months (Corones et al., 1999) and the risk of losing two or more
lines of best–corrected visual acuity is greater than for myopic
treatments (Nagy et al., 2001).
- Ocular integrity
Studies
have indicated that ocular integrity is not significantly compromised
following PRK (Galler et al., 1995). Studies of porcine eyes
examining the force required to rupture the globe after various forms of
refractive surgery, indicate that PRK causes a slight weakening of the
globe compared to untreated eyes but the difference is not statistically
significant (Peacock et al., 1997). Rupture occurs at the sclera
or near the limbus, as in untreated eyes (Campos et al., 1992b).
- Visual performance
Forward
light scatter is known to increase during the first 2 weeks post-PRK,
peaking around three months and returning to normal levels comparable to
spectacle wearers and soft contact lens wearers by 12 months (Miller and
Schoessler, 1995; Veraart et al., 1995). There is evidence to
suggest that the distribution of light scatter around the retinal image
is permanently modified by PRK, with an increase in the spread of
straylight leading to a reduction in retinal image contrast (Chisholm,
2002). The contrast of the retinal image can also be impaired by
surgically induced aberrations (Martinez et al., 1996; Oliver
et al., 1997), the most significant of which is spherical aberration
(Seiler et al., 2000). The degree to which the aberrations of the
eye increase varies considerably between individuals. Since both forward
scatter and aberrations cause a reduction in the retinal image contrast,
low contrast acuity and contrast sensitivity are affected for the first
three months for myopia below –6.00D, and six months for treatments
greater than -6.00D (Esente et al., 1993; Ambrosio et al.,
1994; Pallikaris et al., 1996; Montes-Mico and Charman, 2001). A
permanent reduction in visual performance occurs in a minority,
associated with large induced aberrations or persistent scatter
(Chisholm et al., 2000). Studies indicate that visual performance
under low illumination when the pupil is dilated (and aberrations are
greatest), may be compromised for a year or more, particularly for low
contrast tasks (Strolenberg et al., 1996; Montes-Mico and Charman,
2002). High contrast acuity (Snellen letter chart) is only affected in
severe cases and rarely in those treated for < –6.00D. The increase
in forward light scatter and aberrations also leads to a reduction in
visual performance in the presence of a glare source (glare sensitivity)
during the first month post-PRK, with normal levels returning by about
three months under daylight conditions, but not until 12 months in the
presence of a dilated pupil (low illumination) (Seiler and Wollensak,
1991). A significant reduction in visual performance can occur if there
is a mismatch between size of the ablation zone and the pupil in its
dilated state.
Unlike
RK, diurnal variations in refractive error post-PRK are not clinically
significant (Goldberg et al., 1997; Goldberg and Pepose, 1996),
and neither hyper nor hypobaric conditions cause corneal deformation or
a refractive shift (Hjortdal et al., 1996).
-
Laser Assisted in-situ
Keratomileusis (LASIK)
LASIK
was developed in 1990 (Pallikaris et al., 1991) and involves the
use of a microkeratome to cut a thin flap of tissue followed by ablation
of the underlying corneal tissue (figure 11C). The flap is then
repositioned and is held in place by strong osmotic forces until the
epithelium heals over to cover the wound margins. The aggressive wound
healing that occurs following PRK is not seen post-LASIK because of
limited disruption of the corneal epithelium. This allows much higher
refractive errors to be treated without inducing post-operative haze (Helmy
et al., 1996), minimises pain (Buratto et al., 1993) and
means that useful vision returns almost immediately. Post-operatively, a
C-shaped ring is visible corresponding to the edge of the flap, which
fades with time. Retreatment following LASIK involves lifting the
initial flap and reablating the stromal bed. The time course of corneal
healing post-surgery means that the flap can be lifted for about 12
months after the initial procedure. LASIK is now the most popular
refractive surgery technique in both Europe and America.

Figure 11: Diagrammatic
representation of PRK (B) versus LASIK (C). The corneal epithelium seen
shaded must be removed prior to PRK but remains intact during LASIK, (courtesy
of Mr David Gartry)
- Surgical Outcomes
The
percentage of eyes achieving 6/12 vision or better has been quoted as
86-100% at 6 months post-LASIK for corrections of -8.00D or less (Montes
et al., 1999; Yang et al., 2001), with 88-100% of eyes
achieving a residual refractive error within ±
1.00D of emmetropia. The refraction tends to stabilise within 1-3 months
(Balazsi et al., 2001; Magallanes et al., 2001). Between
zero and 1.2% of eyes treated for myopia <-6.00D lose two or more
lines of best corrected visual acuity (Montes et al., 1999). For
the treatment of myopia up to –6.00D, LASIK is more accurate and
predictable than PRK initially, but this difference evens out by one
year post-surgery (Pop and Payette, 2000; Stojanovic and Nitter, 2001)

Figure
12: The flap of tissue is reflected back to reveal the surface to be reshaped,
(courtesy of Mr David Gartry)
Hyperopic
LASIK has proved slightly more successful than hyperopic PRK for the
correction of low hypermetropia. In a study by Condon (Condon, 1997),
80% of eyes achieved 6/12 or better. The rate of
regression was similar to hyperopic PRK but the stabilisation rate was
approximately four times longer than that following myopic treatment (Corones
et al., 1999). An unacceptably high percentage of patients treated for
hypermetropia > +4.00D lose two or more lines of best corrected
acuity (7.3%) (Ditzen et al., 1998; Goker et al., 1998).
LASIK
has been used to treated a wide range of refractive errors from +8.00D
to –20.00D but the majority of surgeons now restrict LASIK treatment
to those between +4.00D and –10.00D due to the reduction in accuracy,
increased risk of complications and the small optic zones associated
with the correction of high refractive errors (Puk et al., 1996).
- Ocular integrity
There
as been concern about the integrity of the globe post-LASIK, since it is
uncertain whether or not the collagen fibres regrow between the corneal
flap and the ablated stromal bed after surgery. In other words, the flap
may only be attached around its margins by the corneal epithelium, in
which case it would not contribute significantly to the strength of the
cornea. However, a study examining the integrity of the globe following
a range of different refractive surgery procedures, concluded that
although LASIK eyes required slightly less energy to rupture than
control eyes, the difference was not significantly different (Peacock
et al., 1997). LASIK eyes ruptured either at the flap edge or the
limbus. A couple of other studies have also concluded that ocular
integrity is not compromised by LASIK (Cowden et al., 1997;
Galler et al., 1995). The risk of the flap being dislodged is
also very low with one study of rabbit eyes showing that even the
maximum amount of force that could be applied with an airgun (before the
whole eye ball was destroyed), did not lift the flap at one week post-LASIK
(Laurent et al., 2001). This can be attributed to the multiple
layers of corneal epithelium that cover the flap margin. There have been
reports of flap damage as result of focal trauma from the corner of a
paper shopping bag at 3 weeks (Schwartz et al., 2002), and a tree
branch 6 months (Geggel and Coday, 2001) post-LASIK. Following
repositioning of the flap, a good visual outcome was achieved in both
cases.
- Potential complications
Complications
can arise from either the flap or less commonly the laser ablation. Flap
complications include those that occur at the time of surgery, such as
an incomplete or decentred flap, and complications that present after
surgery, such as flap striae and epithelial ingrowth, (nests of trapped
epithelial cells beneath the flap, leading to corneal irregularity and
glare or rarely corneal melt). The vast majority of complications
manifest within the first 6-8 weeks. Surgeon experience is a key factor
in the initial outcome.
Because
the ablation takes place within the cornea, LASIK requires sufficient
corneal thickness to prevent the ablation encroaching within 250µm of
the endothelium, increasing the risk of inducing keratectasia. This is a
rare condition in which induced corneal thinning leads to protrusion of
the corneal tissue, severe irregularity and consequently a reduction in
visual performance. Some cases require a corneal graft to achieve
functional vision. Keratectasia can generally been attributed to
miscalculation of the remaining stromal bed after flap creation, due to
the limited accuracy of microkeratomes, (standard deviation of 30m
m). This is a severe complication that may not present for a year or so
post-surgery (mean of 1 year ± 0.3 (Argento
et al., 2001)). It is almost always associated with treatment for
high myopia since more tissue needs to be removed (Seiler et al.,
1998; Joo and Kim, 2000). The risk of retinal detachment increases with
increasing myopia above approximately –3.00D, and highly myopic eyes
(greater than -10D) also have an increased risk of primary open angle
glaucoma, pigment dispersion syndrome, cataracts and myopic maculopathy
(Mitchell et al., 1999; Ivanisevic and Bojic, 1998; Ivanisevic
et al., 2000; Kanski, 1999). Consequently, some organisations
inadvertently exclude the very individuals who are at greatest risk of
keratectasia should they undergo LASIK, because of potential
complications related to their refractive error.
- Visual performance
As
with RK and PRK, there is still the possibility that
"successful" cases with good visual acuity will suffer from
reduced visual performance due to increased forward light scatter and
aberrations. However, forward light scatter does not appear to increase
significantly following LASIK unless the patient suffers from
complications such as diffuse lamellar keratitis, which is treatable.
Higher-order aberrations are known to increase following LASIK (Oshika
et al., 1999b; Marcos, 2001). Limited study has been made of the
effects of LASIK on visual performance, but initial work suggests that
problems are less common and less severe than those resulting from PRK.
Spatial contrast sensitivity recovers by 3 months in 78% of patients (Alanis
et al., 1996; Perez-Santonja et al., 1998) although one
studied noted a reduction in low contrast acuity under low illumination
at 6 months post-LASIK (Holladay et al., 1999).
-
LASEK
LASEK
is a relatively new technique used for low myopia and hyperopia, falling
part way between PRK and LASIK. It involves the production of an
epithelial flap using a solution of 20% alcohol. The underlying anterior
stroma is ablated, as in PRK, but the epithelial flap is then replaced,
acting as a bandage lens to minimise post-surgical inflammation. It is
currently being used to treat low myopia, where it produces less haze
than PRK and therefore better best-corrected visual acuity (Shah et
al., 2001) and avoids the potential flap complications of LASIK.
There is a rapid recovery of vision following LASEK: in one recent study
of 222 eyes ranging from –1D to –11D, 98% of eyes achieved 6/12
unaided vision within two weeks of LASEK and 63% achieved 6/6 unaided
vision at one year (Claringbold, 2002). The procedure appears to be safe
since no eyes showed a reduction in best-corrected visual acuity despite
the wide range of pre-operative myopia. Another study comparing LASEK
with conventional PRK for the treatment of –3D to –6.5D reported
significantly less corneal haze following LASEK although there was no
significant difference in uncorrected vision or refractive outcome at 3
months post-surgery (Lee et al., 2002). Although some surgeons
believe that LASEK is simply a glorified version of PRK with few real
benefits, others believe that PRK will be replaced by LASEK in the near
future.
- Complications common to
all excimer laser treatments
Individuals
with large pupils under low illumination may suffer from an extreme
version of positive spherical aberration. Peripheral light rays pass
through the untreated cornea and superimpose an unfocussed image over
the clear retinal image giving the appearance of halos around lights at
night (O'Brart et al., 1994a; O'Brart et al., 1994b).
Halos are more common in eyes that have undergone small diameter
ablations, and in patients with naturally large pupils (6.5-7.0mm in
diameter). Ablation diameters of 6.0mm or more have virtually eliminated
halo problems in the majority of patients, although Roberts and Koester
(Roberts and Koester, 1993) suggested the use of even larger diameter
ablations for "at risk" groups, i.e. young patients with large
pupils, those with deep anterior chambers and patients in occupations
where glare is of serious concern.
All
techniques involving modification of the cornea are capable of causing
an increase in forward light scatter and aberrations, and hence a
reduction in visual performance. The effect of these factors on the
quality of the retinal image is discussed further in section
4.
Customised
ablations for excimer laser surgery
Technology
has recently been introduced to allow the pre-operative aberrations of
the eye to be measured and taken in to account during the reprofiling of
the cornea by the excimer laser. The aim is to prevent or minimise the
surgically induced increase in ocular aberrations and perhaps even
reduce the aberrations below their pre-operative level. It remains to be
seen whether this technology will make a significant difference to the
average refractive surgery patient, however, it should significantly
reduce the risk of poor visual performance associated with reduced
optical quality. At this stage it is too early to make an informed
judgement as to whether this technique will provide significant benefit
over conventional laser surgery techniques. Initial results seem to
suggest that aberrations are reduced but there is little benefit for the
average patient (Mrochen et al., 2001; Reinstein, 2002).
-
Potential
Long-term consequences of Photoablation
Since
photoablation is a relatively new technique, the long-term side effects are
as yet unknown. There appear to be no adverse effects on the endothelium,
which controls the hydration of the cornea (Ehlers and Hjortdal, 1992; Amano
et al., 1993; Cannamo et al., 1997). Since the wavelength emitted
by the ArF laser is in the Ultraviolet C range, mutagenesis and
carcinogenesis are a potential worry. However, Nuss and colleagues (Nuss
et al., 1987) found no difference in the unscheduled DNA synthesis, (a
measure of the tissue repair mechanism), between the laser and a gemstone
knife, suggesting that mutagenesis is not a problem. Extensive animal
studies have not detected the development of epithelial or connective tissue
neoplasms resulting from exposure to the laser. One study detected the
presence of short-term changes in the aqueous humour and prolonged
biochemical changes in the crystalline lens of rabbit eyes, which may be the
precursor to cataractogenic changes (Costagliola et al., 1996). In
another study, no significant elevation of MDA (malondialdehyde) levels, (a
possible indicator of oxidative effects), was seen following PRK on rabbits,
although levels were two to three times higher in the LASIK group than the
PRK or control groups, implicating the microkeratome rather than the excimer
laser (Wachtlin et al., 2000). No increase in the incidence of
cataract following PRK or LASIK has been noted to date.
The change
in corneal thickness following corneal refractive surgery has implications
for the measurement of intraocular pressure. When using an applanation
tonometer, a thinner cornea causes underestimation of the intraocular
pressure and vice versa. The removal of Bowman’s membrane and the
deposition of newly synthesised collagen alter the resistance of the cornea
to indentation. A reduction in the apparent intraocular pressure also occurs
when using a non-contact (air puff) tonometer. A mean decrease of 3.1 ±
2.6 mmHg was found, relating to the degree of myopia treated. Pressure drop
(mmHg) = 1.6 - (0.4 * treatment mean spherical error in dioptres) (Chatterjee
et al., 1997).
A number of
refractive surgeons advocate monovision for presbyopic patients, allowing
them to continue to manage without spectacles for the majority of tasks. The
dominant eye is corrected to achieve a refractive error close to emmetropia
and the non-dominant eye is left with a small myopic undercorrection,
usually in the region of about -1.25D. The majority of patients are happy
with monovision although some find the imbalance disturbing and opt to have
the undercorrected eye retreated (Goldberg, 2001). Wright and colleagues
(Wright et al., 1999) examined binocular function in a group of 21
patients with a monovision correction and compared them to a group of
patients who had been fully corrected in both eyes. Both groups were treated
with PRK. All patient’s maintained binocular fusion and some degree of
stereopsis. From personal experience in Optometric practice (CMC), some
monovision patients complain of poor contrast acuity at night, probably due
to the reduced stimulus to the binocular cortical cells. Those who are most
satisfied appear to be those with lower visual expectations. The
implications of monovision for tasks such as rapid response driving have not
been considered.
©
British Society for Refractive Surgery and Catharine Chisholm
|