PRK CONSENT FORM
Photorefractive Keratectomy
2 Wisconsin Circle, Suite 200 • Chevy Chase, MD 20815
240.482-1200 • FAX: 240.482-1235 • Toll Free: 866.578-2020
Introduction
Photorefractive Keratectomy, or PRK, is a permanent vision correction procedure in which
tissue is removed from the surface of the eye (the cornea) using an excimer laser. Precise control of
tissue removal and management of the healing process can result in reduced dependence on
corrective lenses for most patients.
The Food and Drug Administration (FDA) regulates the manufacture and use of the excimer
laser in the U.S. The use of the VISX STAR™ S4 Laser System, currently being used at UOCW
Vision Centers, has been approved by the FDA for the treatment of myopia (nearsightedness) and
hyperopia (farsightedness) with or without astigmatism.
This Patient Consent Form generally describes the PRK procedure and outlines certain risks
and possible benefits. Before electing to undergo PRK, you must have a complete eye examination
and should fully discuss the potential risks, complications, and time for healing with an eye care
professional. You are encouraged to ask questions at any time about PRK or about any statements
made in this form.
How the Eye Works
To better understand PRK and how the excimer laser can be used to correct vision problems
resulting from refractive error, a short review of how the eye works may be helpful. Refractive errors
(myopia, hyperopia, and astigmatism) generally result from an abnormally or irregularly shaped eye.
When light enters the eye, it is bent (refracted) by a clear, strong tissue at the front of the eye
called the cornea. The cornea, in effect, acts like a lens to bend and focus incoming light onto the
retina at the back of the eye. It is further bent by the crystalline lens located behind the iris (the
colored part of the eye).
In nearsightedness, or myopia , light entering the eye does not focus on the retina as it should,
but instead focuses images at a point in front of the retina. Myopia is caused either by an abnormally
long eye or by a steep curvature of the cornea. The result of myopia is that distant objects appear
blurry, while objects near to the viewer can be seen in focus.
In farsightedness, or hyperopia, light entering the eye focuses images at a point behind the
retina. Farsightedness is caused by an abnormally short eye or by an excessively flat cornea. The
result of hyperopia is that objects near to the viewer appear blurry while objects in the distance may
be seen in focus.
In astigmatism , the problem is not the length of the eye but the shape of the cornea. The
cornea is not spherical and has different curvatures - it is typically shaped more like a football than a
basketball, i.e., one flat curvature and one steeper curvature. The result is that objects are not
focused into a single image on the retina, and vision is distorted or blurry. Myopic and hyperopic
eyes can also be astigmatic.
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Presbyopia , or the inability to see close-up objects, usually becomes apparent to most people
in their early to mid-40s. This condition occurs normally with age and is caused by a change in the
elasticity of the internal crystalline lens, resulting in the lost ability to focus on near objects.
PRK, which treats the surface tissue of the eye, cannot be used to correct presbyopia,
although patients may select monovision correction, which will be explained later.
Vision Correction Alternatives
Vision problems resulting from refractive error (myopia, hyperopia, and astigmatism) are
typically corrected either with eyeglasses or contact lenses.
Customized treatments are now available for patients with mild and moderate amounts of
nearsightedness (up to -14.00D), farsightedned (up to +5.00D), and astigmatism (up to +6.00D). The
use of the excimer laser and limits regarding the range of treatment are regulated by the FDA.
In addition to PRK, a procedure known as Radial Keratotomy (RK) is also sometimes used to
treat nearsightedness and astigmatism and in selective cases, hyperopia. While RK sounds similar to
PRK, the two procedures are different and should not be confused. In RK, the surgeon uses a handheld
blade to make a pattern of incisions in the cornea that look like the spokes of a wheel. The
incisions weaken the structure of the eye and permit the cornea to flatten as scar tissue forms, thus
shortening the length of the eye and correcting the refractive error.
LASIK, or laser in-situ keratomileusis, is a procedure for the treatment of refractive errors. In
LASIK, the surgeon uses a microkeratome, an automated device with a blade, to create a flap about
160 microns thick (one-third of the cornea) across the surface of the eye. This flap, which remains
attached on one side, is folded back, and the excimer laser is used to remove the underlying stromal
tissue. Following laser ablation, the flap is laid back in place. If laser retreatment is required, the flap
can be lifted for retreatment of the underlying tissue.
The Excimer Laser
PRK uses an excimer laser for vision correction. No incisions are made to the eye. The
corneal epithelium is scraped away, and the cornea is reshaped using the energy from pulses of light
emitted by the excimer laser. A bandage contact lens is then placed on the cornea for a few days
until the corneal epithelium regenerates.
Ultraviolet light with wavelengths less than 300 nanometers will not penetrate through the
surface of the eye. Because of this, the excimer laser (with a wavelength of 193 nanometers) does
not transmit energy through the cornea to the internal tissues of the eye. Instead, the ultraviolet light
is absorbed in the surface cells of the eye giving the excimer laser its unique ability to reshape these
surface tissues. As the ultraviolet light is absorbed by the surface of the eye, tissue is vaporized, or
ablated. Essentially no heat is generated in the process, therefore, the risk of scarring is minimized.
The energy of the laser is controlled so that each pulse precisely ablates thin layers of tissue from the
cornea, 1/4000 of a millimeter at a time. It would take about 200 pulses from an excimer laser to etch
through one human hair. The laser is programmed specifically for each patient. It is controlled by a
computer which determines the location, number of pulses, and surface area to be impacted by the
laser light beam.
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Contact Lens Wear
Contact lenses can distort the curvature of the cornea. Therefore, before being evaluated for
PRK and before the treatment can be performed, the shape of the eye must be allowed to stabilize to
its natural shape.
Patients who wear toric (astigmatic) soft contact lenses, rigid gas permeable lenses, or hard
lenses must stop wearing their lenses at least three weeks prior to the procedure. Patients who wear
daily wear soft contact lenses must stop wearing their lenses at least three days prior to the
procedure. You must confirm compliance with these requirements prior to undergoing PRK. The
period required to stabilize the natural shape of the cornea may be longer for some patients. You
must contact your eye doctor if you suspect that your vision is continuing to fluctuate as your eye
returns to its normal shape following removal of your contact lenses.
Contraindications
An individual is a poor candidate for PRK if any of the following conditions exist:
1. Unstable refractive error;
2. Large pupils (greater than 7 millimeters in low light conditions);
3. History of keloid formation;
4. Keratoconus (progressive thinning/steepening of the cornea);
5. Keratitis sicca (advanced dry eyes);
6. Diabetes, uncontrolled;
7. Glaucoma, uncontrolled;
8. Expectant or nursing mothers;
9. Cataracts;
10. Heart condition requiring pacemaker regulation;
11. Recurring ocular herpes simplex; or
12. Active ocular inflammatory disease.
If you know that you have any of these conditions, you must inform your eye doctor.
The PRK Laser Procedure
Upon arriving at UOCW Vision Centers, a final check of your eyes will be completed. Your
eyes are measured and mapped, and the information is reviewed to detect and isolate any
irregularities in the shape of the cornea. Before performing the procedure, our clinical staff will review
the procedure with you, answer any questions, and conduct additional examinations as appropriate.
Most patients dress casually - comfortably and warmly - as the room is cool for optimum
laser performance. Please do not wear make-up, colognes, perfumes or scented lotions as this will
affect the optics of the laser. You will be asked to remove any scents before entering the laser suite.
You may not drive yourself home after the procedure, therefore you must arrange to bring a
companion or make advance arrangements for transportation. Your companion may accompany you
through the entire process until you actually enter the laser suite.
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You will not be given general anesthetic. We do premedicate with .5mg of Xanax for your
optimal relaxation during the procedure. Medications administered during the procedure are eye
drops - anesthetic (numbing), antibiotic, and/or non-steroidal, anti-inflammatory medications, as
appropriate. While allergic reactions to these medications are rare, please advise clinical personnel of
any medication allergies you may have.
In the laser room, you will be positioned on a bed which rotates for proper positioning. Your
eyelids will be cleansed, and the eye that is not being treated will be covered. An anesthetic drop will
be instilled in your eye, and an eyelid speculum will be placed between your upper and lower eyelids
to prevent you from blinking during the procedure.
To begin the actual PRK treatment, your surgeon will remove the protective epithelium on the
surface of your eye. This can be removed either manually or with the laser, and your surgeon will
determine which method is appropriate for your eyes.
After removal of the epithelium, the surgeon will ask you to stare at the blinking red light. The
laser will be activated, and the reshaping of your cornea will begin. The red light will become more
difficult to see as the treatment progresses. While the laser is in use, you will be asked to keep your
head and eye as still as possible, however, a small amount of eye movement should not affect the
outcome of the procedure. If significant movement is apparent, the surgeon will stop the laser and
realign your eye.
Total laser treatment time for most patients is less than 60 seconds per eye. Your surgeon
will tell you how you are doing throughout the procedure.
During the procedure, you will notice distinctive sounds and smells. For example, the laser
makes a clicking noise when in use. The surgeon will tell you before the pulse begins so that the
noise does not startle you. Laser ablation of eye tissue may also produce an odor which some
patients find unpleasant. The laser is equipped with a suction device to minimize this.
Once reshaping of the cornea is complete, additional eye drops are instilled, a protective soft
contact lens is inserted, and the eyelid speculum is removed.
If you are having both eyes done on the same day, your surgeon will transfer the patch from
the fellow eye to the just-treated eye and the above procedure will be repeated. The total time in the
laser room is usually less than 20 minutes.
Post-Procedure Expectations
After the procedure, you will be advised to rest for the remainder of the day and to continue
using eye drops as prescribed and instructed. The epithelium, which was removed for the procedure,
regenerates itself, usually over a two to four day period. Your post-operative manager will determine
when the bandage contact lens should be removed.
During the healing process - after removal of the bandage lens - some patients will
experience varying degrees of discomfort, from a mild scratchy, burning, or foreign body sensation to
more severe pain, which should be reported to your post-operative caregiver. In rare cases, the eye
may be patched with a pressure patch to inhibit blinking and restrict eye movement.
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Although there is a minimal risk of infection with either the use of the contact lens or the patch,
the risk is thought to be slightly higher with the contact lens. In addition to the probability of
experiencing less post-procedure discomfort, patients with a contact lens have their eye open,
permitting useful (although blurry) vision, which is obviously not possible if the eye is patched.
After the procedure, you will receive a kit containing anti-inflammatory eye drops and a
schedule for their use. You will also continue the antibiotic eye drops started before your surgery.
You may be provided with a prescription for oral pain medications for any discomfort, pain, or difficulty
sleeping.
You are likely to be sensitive to light and may not be able to see well enough to accomplish
even simple tasks like reading a menu for two to three days following PRK. You will appreciate having
a companion along. You should not drive during this period.
Patients return to UOCW Vision Centers or their co-managing optometrist on the day following
the procedure to confirm the fit of the protective contact lens and to ensure that the healing process is
progressing satisfactorily.
If you are healing as anticipated and no discomfort is present, the bandage lens will be
removed on the third or fourth day following the procedure. In some cases, an additional day or two
is required to make sure the healing process is advancing.
You should refrain from driving until your vision is sufficiently restored to make driving safe.
Your doctor will monitor your recovery and your continued use of eye drops. Steroid eye
drops are often used after the procedure to reduce redness, eye irritation, and to regulate healing
response. Regular follow-up visits are required, as the use of steroid eye drops can cause an
increase in intraocular eye pressure in some patients. Follow-up evaluation visits are generally
scheduled within ten days after the procedure, then as needed for the first six months after the
procedure, with a final follow-up visit one year after the procedure.
Risks and Other Considerations
No vision correction procedure is risk free. In addition, because PRK is a relatively new
procedure introduced in 1987, there may be long-term risks, which are unknown at this time.
Risks and discomforts that might be associated with the PRK procedure are as follows:
1. Discomfort: Many patients experience mild discomfort for a few days following PRK, although
reactions range from no discomfort at all to moderate pain. Some patients may experience a
burning sensation for a few moments when instilling the eye drops. Loss or excessive
movement of the protective contact lens can be quite painful. Patients losing the protective
contact lens should keep their eye closed and contact an eye doctor to reinsert a protective
lens. Most patients who have discomfort describe it as the sensation of having grains of sand
or an eyelash in their eyes or having a torn contact lens. Some sensitivity to light exists
among most patients during the period in which the epithelium is healing.
2. Blurry Vision: During the two to four-day period when the epithelium is healing, vision is
blurry for most patients. Once the bandage lens is removed, vision when looking at objects
within six to ten feet will appear as if looking through glasses coated with a thin film of
petroleum jelly. Blurry vision clears for most people in a week or two as the surface of the eye
heals and again becomes smooth. However, complete smoothing of the surface tissue of the
treated eye may take as much as six months. During this period, there may be some
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fluctuation in vision. The healing process varies from patient to patient.
3. Reading Difficulty: Most patients will find it difficult to read in the first few days following PRK.
People with greater levels of correction and those over 40 who are experiencing the effects of
presbyopia may have greater difficulty reading without the use of corrective lenses for longer
periods immediately following the procedure.
4. Corneal Haze: Corneal haze, which in most cases can only be detected by an eye care
professional using a microscope, is typical following PRK. Corneal haze, if present, is most
noticeable in the period two to four months following the laser procedure. It usually has little
or no effect on vision and is usually not present after six months. A few patients do
experience excessive corneal haze and require treatment. Additional treatment with the
excimer laser can generally correct problems of excessive haze.
5. Diminished Night Vision: Some patients who have undergone PRK experience a halo or glare
effect from the edge of the treatment zone or from excessive haze. This effect is noticeable in
dim light conditions, particularly for those patients with large pupils, and can interfere with
night driving. Significant corneal haze can also result in loss of visual acuity in dim light
conditions.
6. Elevated intraocular pressure: An increase in intraocular pressure (IOP) can occur in patients
who use topical steroid eye drops. Typically, IOP returns to normal - with no long-term ill
effects - once the use of steroid eye drops has been discontinued. However, if IOP is
elevated on a long-term basis, permanent loss of vision can result. Since elevated IOP is
often painless, periodic evaluation by an eye doctor is imperative. Monitoring IOP is an
important part of the follow-up care provided by your eye care professional.
7. Slow Epithelial Regeneration: The epithelium removed just before the laser procedure begins
usually heals in two to four days, but occasionally it heals at a slower rate than expected. In
such cases, there may be increased pain and risk of infection.
8. Undercorrection: There is no guarantee that PRK will be successful in providing the desired
level of vision correction. The chance of being under-corrected increases in cases where
higher grades of myopia are being treated. If the desired level of vision correction is not
achieved, corrective lenses may still be necessary to achieve the best corrected visual acuity.
Corrective lenses may also continue to be necessary for certain activities (such as reading or
close work). In some, but not all, cases undercorrections can be retreated with an
enhancement procedure. Retreatment is usually not performed until vision has totally
stabilized, typically about six months after the original procedure.
9. Overcorrection: In rare cases, too much tissue may be ablated from the central area of the
cornea resulting in an overcorrection. In some cases, it is possible to retreat. In some
circumstances, corrective lenses would be needed.
10. Regression: In some patients, the vision correction effects of the procedure diminish several
months after the procedure. This complication is more common in patients who are very
nearsighted. In some, but not all cases of significant regression, another PRK procedure helps
to remedy the effect.
11. Presbyopia: Presbyopic or emerging-presbyopic patients must understand that PRK vision
correction does not treat this age-related process, and they will require reading glasses for
reading and other close work.
12. Loss of Best-Corrected Visual Acuity: Some patients may lose the ability to read one or two
lines on the eye chart in comparison to their previous best-corrected vision. This loss of acuity
can occur as a result of microscopic corneal surface irregularities. Loss of acuity can also
occur as a result of decentration. One cause of decentration is significant eye movement on
the part of the patient when the laser is pulsing. A small amount of eye movement will
typically not affect the outcome of the procedure, however.
13. Inconvenience Between Procedures: In the event that a patient has PRK performed on just
one eye at a time, the two eyes may not work well together until the fellow eye is done. A
patient's ability to work and drive may be impaired unless the patient procures a temporary set
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of corrective lenses. Glasses may not adequately compensate for the difference in refraction
between the eyes. Contact lenses are more likely to provide acceptable vision correction in
cases of significant differences in the refractive error. Contact-intolerant patients must
consider the implications in cases where both eyes are not treated at the same time.
14. Sensitivity: Some patients, experience increased sensitivity to any contact with the surface of
the eye following PRK. This tends to diminish over time, but increased sensitivity could be a
concern in some professions.
Remote Risks
As with any procedure of this type, there is a remote possibility of infection, drug reaction, or
other rare complication, which could cause partial loss of vision.
Long-Term Effects
Because Photorefractive Keratectomy, or PRK, is a relatively new procedure, the long-term
effects and consequences of the procedure have not been fully determined.
Possible Benefits
In many cases, PRK results in a person's reduced dependence on eyeglasses and contact
lenses. Studies conducted by laser manufacturers and reviewed by the U.S. Food and Drug
Administration suggest that more than 94% of patients achieve 20/40 or better distance vision
(sufficient to qualify for a driver's license without corrective lenses in most states) with one PRK
treatment when correcting myopia of less than six diopters of refractive error.
Some patients may elect to correct their distance vision in one eye while leaving the other eye
slightly nearsighted. This option - monovision - corrects one eye for distance and the fellow eye for
near. Many monovision patients may decide to get night driving glasses to fully correct their near
vision eye for distance.
There may also be psychological and social benefits for patients who feel that they look better,
or can function better, without glasses or contacts.
CONSENT FOR PHOTOREFRACTIVE KERATECTOMY
I have read this consent form. I have discussed it with my eye doctor and have been given
the opportunity to ask questions. All of my questions have been answered to my satisfaction. I
understand how PRK is performed and acknowledge its possible risks and complications.
I understand that:
1.
The manufacture and use of the excimer laser for refractive surgery is regulated by the U.S.
Food and Drug Administration (FDA).
2. PRK is an elective procedure. There is no health or medical reason why I need to have PRK.
3. Alternative treatments to PRK, including eyeglasses and contact lenses, are available.
4.
The results of the PRK procedure cannot always be predicted. The safety and efficacy of
PRK cannot be guaranteed. I may still need eyeglasses or contact lenses to achieve
satisfactory vision after the procedure.
5. PRK is not risk-free. Complications from the procedure, as described in this consent form, are
possible. Retreatment may be necessary, but there is no guarantee that retreatment will be
successful. As with any procedure of this type, there are remote risks, such as partial loss of
best-corrected visual acuity.
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6. Adherence to the recommended eye medication regimen and periodic follow-up visits with an
eye doctor after the PRK procedure are required to reduce the risk of longer-term
complications and increase the likelihood that the desired outcome will be achieved.
I confirm that I am neither pregnant nor a nursing mother and that I will notify my doctor if I
become pregnant in the six-month period following PRK treatment. I understand that pregnancy may
affect my healing response. I also understand that some medications may pose a risk to an unborn
or nursing child.
My decision to undergo PRK has been my own and has been made without duress of any
kind. I understand that, if at any time prior to my procedure, I decide that I do not want to go forward
with PRK, I may withdraw my consent.
I authorize the eye doctors involved in performing my PRK procedure and in providing my pre-
and/or post-procedure care to share with one another any medical information relating to my health,
my vision, or my PRK procedure which they deem relevant to providing care.
I understand that information gathered about my procedure and my post-procedure care may
be used to study the PRK procedure. I give permission for my medical records to be released to
persons involved in such studies and for my case to be presented at professional or scientific
meetings or published in journals, as long as I am not identified by name. I also give permission for
my PRK procedure to be observed and for the procedure to be photographed by still camera, movie
camera, or videotape, and for these photographs, films or tapes to be shown at professional,
scientific, educational, promotional, or similar meetings or published in journals, so long as my name
is not revealed.
I understand that third parties may be contracted to provide certain services, including patient
scheduling, medical data processing, quality assurance analysis, patient billing, and practice
management. I give permission for the release of my medical information relating to my PRK
procedure to such third parties.
I agree to accept personal financial responsibility for the payment of all charges and fees
related to my PRK procedure, including charges for the procedure itself, for medications I may need,
for pre- and post-procedure care, for any eyeglasses or contact lenses required after the procedure,
and for the expenses connected with my travel to UOCW Vision Centers or other professional offices
where I receive care. In the event that I have insurance which covers all or part of the cost of my
PRK procedure and follow-up care, I authorize the release of information relating to my PRK
procedure for insurance or payment purposes.
I understand the risk in undergoing Photorefractive Keratectomy, or PRK. I wish to have PRK
performed and hereby consent to the procedure and to any pre- or post-procedure care which my eye
doctors deem necessary or advisable.
I verify that I have not worn nor will I wear rigid gas permeable or hard contact lenses at any
time in the three-week period prior to undergoing PRK, and I have not worn nor will I wear soft
contact lenses at any time in the three-day period prior to undergoing PRK.
I understand that, in the event I need an enhancement, treatment will be performed by the
surgeon who performed the prior PRK procedure, if at all possible. I also understand that I will be
required to return to UOCW Vision Centers and that any expenses for transportation and lodging will
be my responsibility.
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I consent to undergo PRK for correction of (circle one):
Myopia Myopia with astigmatism
Hyperopia
Hyperopia with astigmatism
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Patient Signature
Date
Time
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Patient Printed Name
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Witness Signature
Witness Printed Name
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Surgeon Signature
Date
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Surgeon Printed Name
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