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Archive / FAA Aeromedical Safety Brochures / FAA Aeromedical Safety: Information for Pilots Considering Laser Eye Surgery

Information for Pilots Considering Laser Eye Surgery

Information for Pilots Considering Laser Eye Surgery

FAA Aeromedical Safety Brochure

Currently, about 55% of the civilian pilots in the United States

must utilize some form of refractive correction to meet the vision

requirements for medical certifi cation. While spectacles are the most

common choice for aviators, recent studies show a growing number

of pilots have opted for refractive surgical procedures, which include

laser refractive surgery. The information in this brochure describes

the benefi ts as well as possible pitfalls laser refractive surgery offers

to those considering these procedures.

What is Refractive Error?

Refractive error prevents light rays from being brought to a single

focus on the retina resulting in reduced visual acuity. To see clearly,

refractive errors are most often corrected with ophthalmic lenses

(glasses, contact lenses). The three principal types of refractive

conditions are myopia, hyperopia, and astigmatism. Another

ophthalmic condition that also results in blurred near vision is called

presbyopia. Presbyopia is a progressive loss of accommodation

(decreased ability to focus at near distance due to physiological

changes in the eye’s crystalline lens) that normally occurs around 40

years of age. Bifocals or reading glasses are necessary to correct this

condition.

Myopia (nearsightedness, distant objects appear fuzzy) is a condition

in which light rays are focused in front of the retina. About 30% of

Americans are myopic.

Hyperopia (farsightedness, near objects appear fuzzy) is a condition

in which light rays are focused behind the retina. An estimated

40% of Americans are hyperopic. However, this number may not

be accurate. Young hyperopes (< 40 years), who can compensate

for their farsightedness with their ability to accommodate, are often

not counted in this number and some studies incorrectly include

presbyopes, who also require plus power lenses to see clearly.

Astigmatism is a condition often caused from an irregular curvature

of the cornea. As a result, light is not focused to a single image on the

retina. Astigmatism can cause blurred vision at any distance and may

occur in addition to myopic or hyperopic conditions. Approximately

60% of the population has some astigmatism.

What is Laser Refractive Surgery?

In October 1995, the Food and Drug Administration (FDA) approved

the use of the excimer laser to perform a refractive procedure

called Photorefractive Keratectomy (PRK). PRK improves visual

acuity by altering the curvature of the cornea through a series of

laser pulses. The laser photoablates (vaporizes) the corneal tissue

to a predetermined depth and diameter. PRK can be used to correct

myopia, hyperopia, and astigmatism. Reported PRK problems such

as postoperative pain, prolonged healing period, increased risk of

infection, and glare (halos) at night, has resulted in Laser in situ

Keratomileusis (LASIK) becoming the preferred choice for refractive

surgery by patients and eyecare practitioners. A survey in the United

States found that the percentage of refractive surgeons performing

PRK had decreased from 26% in 1997 to less than 1% in 2002.

LASIK is performed using two FDA approved devices: the

microkeratome and excimer laser. During the LASIK procedure, the

microkeratome slices a thin fl ap from the top of the cornea, leaving

it connected by a small hinge of tissue. The corneal fl ap is folded

aside and the excimer laser is used to reshape the underlying corneal

stroma. The fl ap is then returned to its original position.

Is LASIK an Option for Me?

An eye care specialist should thoroughly evaluate your current

ocular health and correction requirements to determine whether you

are a suitable candidate for refractive surgery. Clinical trials have

established the following selection criteria for LASIK.

Selection Criteria:

4 Age 18 years or older

4 Stable refractive error (less than .50 diopters [D] change within

the last year) correctable to 20/40 or better

4 Less than - 15.00 D of myopia and up to 6 to 7 D of astigmatism

4 Less than + 6.00 D of hyperopia and less than 6 D of

astigmatism

4 No gender restriction, with the exception of pregnancy

4 Pupil size less than or equal to 6 mm (in normal room lighting)

4 Realistic expectations of fi nal results (with a complete

understanding of the benefi ts, as well as the possible risks)

In addition to conforming to the above criteria, it is important that you

possess normal ocular health and be free of pre-existing conditions

that may contraindicate LASIK.

Contraindications:

4 Collagen vascular disease (corneal ulceration or melting)

4 Ocular disease (dry eye, keratoconus, glaucoma, incipient

cataracts, herpes simplex keratitis, corneal edema)

4 Systemic disorders (diabetes, rheumatoid arthritis, lupus, HIV ,

AIDS)

4 History of side effects from steroids

4 Signs of keratoconus

4 Use of some acne medication (e.g., Accutane and/or Cordarone)

Is LASIK Safe for Pilots?

Aviators considering LASIK should know that in initial FDA trials

reporting high success rates (> 90%) and low complication rates (<

1%), the criteria for success varied. In most clinical studies, success

was defi ned as 20/40 or better distant uncorrected visual acuity

(UCV A) under normal room lighting with high contrast targets, not

20/20 or better UCV A. While the majority of patients do experience

dramatic improvement in vision after laser refractive surgery,

there is no guarantee that perfect UCV A will be the fi nal outcome.

Even successful procedures may leave many patients with a small

amount of residual refractive error that requires an ophthalmic

device (eyeglasses or contact lenses) to obtain 20/20 visual acuity. If

overcorrection results, patients may need reading glasses.

Compared to its predecessor (PRK), LASIK requires higher technical

skill by the surgeon because a corneal fl ap must be created. Although

rare, loss of best corrected visual acuity (BCV A) can occur when there

are surgical complications such as those summarized below.

Surgical Complications:

4 Decentered or detached corneal fl ap

4 Decentered ablation zone

4 Button-hole fl ap (fl ap cut too thin resulting in a hole)

4 Perforation of the eye

Operation of an aircraft is a visually demanding activity performed

in an environment that is not always user friendly. This becomes

particularly evident if the choice of vision correction is ill-suited for

the task. While the risk of serious vision-threatening complications

after having LASIK is low

(< 1%), some complications

could have a signifi cant impact

on visual performance in a

cockpit environment.

Relative Risk of Post-Surgical Complications:

Prolonged healing periods: 3 months or more

Night glare (halos, starbursts): 1 in 50

Under/over

-correction: less than 1 in 100

Increased intraocular pressure: non signifi cant

Corneal haze: 1 in 1,000

Corneal scarring: non signifi cant

Loss of BCV A: 1 in 100

Infection: 1 in 5,000

Corneal fl ap complications (dislocated fl ap, epithelial ingrowth):

less than 1 in 100

Following LASIK, patients are cautioned to avoid rubbing their eyes

and to stay out of swimming pools, hot tubs, or whirlpools for at

least a week. Contact sports should be avoided for a minimum of 2

weeks, and many eye surgeons recommend wearing safety eyewear

while playing sports. Even after the patient’s vision has stabilized and

healing appears complete, the corneal fl ap may not be completely re-

adhered. There have been reports of corneal fl ap displacement due to

trauma up to 38 months after the procedure.

After surgery, patients are cautioned to not wear eye makeup or use

lotions and creams around their eyes for a minimum of 2 weeks and

to discard all previously used makeup to reduce the risk of infection.

In some instances, LASIK may be an option for patients with higher

refractive error than can be safely corrected with PRK or those with

conditions that can delay healing (e.g., lupus, rheumatoid arthritis).

Since LASIK minimizes the area of the epithelium surgically

altered, it reduces some of the risks associated with delayed healing.

Additionally, ablation of the underlying stromal tissue results in less

corneal haze and the tendency for the cornea to revert back to the

original refractive condition during the healing process (refractive

regression), which improves predictability. Most patients do not

require long-term, postoperative steroid use, decreasing the possibility

of steroid-induced complications (cataract, glaucoma).

As with any invasive procedure, there are surgical risks, and the

recovery process often varies with each individual. Post-LASIK

patients report experiencing mild irritation, sensitivity to bright light,

and tearing for a few days after surgery. For most, vision stabilizes

within 3 months to near-predicted results, and residual night glare

usually diminishes within 6 months. In rare cases, symptoms have

lingered longer than a year. Earlier versions of LASIK used a smaller

ablation zone which sometimes resulted in glare problems at night.

Ablation zones have an area of transition between treated and

untreated corneal tissue. As the pupil dilates and becomes larger than

the ablation zone, light (car headlights, streetlights, and traffi c signals

lights) entering through these transition areas becomes distorted,

resulting in aberrations perceived as glare. These patients often

complain of diffi culties seeing under low-light conditions.

Patients that develop postoperative haze during the healing process

have complained of glare (halos and starbursts). Furthermore, it has

been reported that exposure to ultraviolet radiation or bright sunlight

may result in refractive regression and late-onset corneal haze. It

is therefore recommended that all refractive surgery patients wear

sunglasses with UV protection and to refrain from using tanning beds

for several months after surgery.

For those with larger amounts of refractive correction, the

predictability of the resulting refractive correction is less exact.

This can lead to under-correction (requiring an additional laser

enhancement procedure and/or corrective lenses) or over-correction

of the refractive error. In the case of overcorrection, premature

presbyopia and the need for reading glasses can result.

It has been reported that there can be a slower recovery of BCV A and

UCV A with hyperopic LASIK compared with those having myopic

LASIK. This is especially true for older patients who may be even

less likely to achieve UCV A of 20/20 or better. (Note: Loss of BCV A

is reportedly 5 to 15 times more likely with refractive surgery than

from the use of extended-wear contact lenses.)

Older patients with presbyopia may opt for monovision LASIK,

which corrects the dominant eye for distant vision and the other

eye for near vision. The procedure is intended to eliminate the need

for a patient to wear corrective lenses for near and distant vision.

Anisometropia (difference in correction between the eyes) induced

by monovision may result in decreased binocular vision, contrast

sensitivity, and stereo acuity. After an adaptation period, patients are

often able to see and function normally. Patients who report blurred

vision, diffi culty with night driving, and other visual tasks in low-light

conditions typically do not adapt to monovision and may require an

enhancement on their non-dominant eye so that both eyes are fully

corrected for distant vision. Airmen who seek monovision correction

should consult an eye care practitioner to assist them in compliance

with standards outlined in the “Guide for Aviation Medical Examiners

(see below):

Airmen who opt for monovision LASIK must initially wear correction

(i.e., glasses or contact lens) for near vision eye while operating an

aircraft. After a 6-month period of adaptation, they may apply for a

Statement of Demonstrated Ability (SODA) with a medical fl ight test.

If the airman is successful, the lens requirement is removed from their

medical certifi cate.

Advances in Refractive Surgery

Wavefront LASIK

Eye care specialists have traditionally used standard measurement

techniques that identify and correct lower-order aberrations, such as

nearsightedness, farsightedness, and astigmatism. However, no two

people share the same eye irregularities or have similar refractive

needs. Vision is unique and as personal as fi ngerprints or DNA.

Wavefrontontont technology allows eye surgeons to customize the LASIK

procedure for each eye, providing the possibility of even better vision.

The FDA approved the fi rst system for general use in October 2002.

A laser beam is sent through the eye to the retina and is refl ected

back through the pupil, measuring the irregularities of the light wave

(wavefront) as it emerges from the eye. This process produces a three-

dimensional map of the eye’s optical system. Measuring the cornea’s

imperfections or aberrations in this way allows the refractive surgeon

to develop a personalized treatment plan for the patient’s unique

vision needs. Correcting the patient’s specifi c imperfections can result

in sharper vision, better contrast sensitivity, and reduces problems

associated with higher-order aberrations after surgery, such as haloes

and blurred images. Studies indicate that 90-94% of patients receiving

technology allows eye surgeons to customize the LASIK

wavefront LASIK achieved visual acuity of 20/20 or better. However,

those with thin corneas, high degrees of aberrations, severe dry eyes,

or conditions affecting the lens and vitreous fl uid inside the eye may

not be good candidates for wavefront LASIK.

Other Advances in Refractive Surgery

The eye’s optical system creates a limit as to how wide and deep the

laser ablation should be, i.e., the wider the ablation, the deeper the

laser must ablate into the cornea, which may result in delayed healing

and prolonged visual recovery. The development of new lasers allows

the creation of a wider ablation zone while removing the least amount

of tissue. Studies have shown that this reduces problems with night

vision and other side effects associated with laser refractive surgery.

Laser technology that provides variable optical zone sizes and beam

shapes with scanning capabilities allows the eye sur

geon greater

fl exibility in developing a more personalized laser vision procedure.

A spot laser may be adjusted so minimal spherical aberrations are

produced and a larger optical zone is created. Results from clinical

trials indicate that 67% of eyes had UCV A of 20/16 or better and 25%

had 20/12.5 or better. Additionally, there was an overall improvement

in nighttime visual function and night driving, which is achieved by

preserving the optical zone size and better shaping of the ablation

profi le.

During traditional LASIK, the corneal fl ap is created with a

mechanical microkeratome manipulated by the surgeon’s hand.

While this method has worked well over the years, the performance

of these devices can be unpredictable and is the source of a majority

of surgical complications. These diffi culties result in irregularities in

thickness between the central and peripheral areas of the fl ap that can

induce postoperative astigmatism.

The IntraLase Femtosecond Laser Keratome, which received FDA

approval in December 1999, is the fi rst blade-free technology for

creating the corneal fl ap. The laser keratome beam passes into the

cornea at a predetermined depth, producing a precise cut that is

reportedly more accurate than the microkeratome. Corneal fl aps made

with the laser keratome appear to adhere more tightly to the corneal

bed at the end of the procedure, which may eliminate problems with

long-term fl ap displacement. A reported disadvantage to this new

technology is that surgical time is increased, leaving the stroma

exposed several minutes longer, which has led to reported complaints

of photophobia and eye irritation for up to two days after surgery.

While it may take longer (4 to 7 days) to recover good vision, the

approach appears to be associated with a lower incidence of dry eyes,

corneal complications, and enhancement procedures compared with

traditional LASIK.

The FAA requires that civil airmen with refractive surgical procedures

(e.g., PRK, LASIK) discontinue fl ying until their eyecare specialist

has determined that their vision is stable and there are no signifi cant

adverse effects or complications. The airman should submit one of

two documents to the FAA (a report from their eyecare specialist or

“Report of Eye Evaluation” [FAA-8500-7]). These reports can be

submitted directly to the Aerospace Medical Certifi cation Division

when released from care, or to their Aviation Medical Examiner

during their next fl ight physical. This report should state:

“. . . . that the airman meets the visual acuity standards and the

report of eye evaluation indicates healing is complete, visual acuity

remains stable, and the applicant does not suffer sequela, such as

glare intolerance, halos, rings, impaired night vision, or any other

complications. . . .” (Guide for Aviation Medical Examiners, July

2005)

If you are a pilot contemplating refractive surgery, consult an eyecare

specialist to determine if you are a good candidate for laser refractive

surgery. Although the FAA and most major air carriers allow laser

refractive surgery, professional aviators should consider how it

could affect their occupational and certifi cation status. As with any

invasive procedure, there are many variables that can infl uence the

fi nal outcome. You should understand all risks as well as the benefi ts

before electing to have a procedure performed that could compromise

your visual performance in the cockpit.

MEDICAL FACTS FOR PILOTS

Publication OK-06-148

Written by:

Van B. Nakagawara, O.D., F.A.A.O.

Kathryn J. Wood, CPOT

Ron W. Montgomery, B.S.

For additional copies, download from our Web site:

www.faa.gov/pilots/safety/pilotsafetybrochures/

Or contact:

FAA Civil Aerospace Medical Institute

Aerospace Medical Education Division

AAM-400, P.O. Box 25082

Oklahoma City, OK 73125

Original source PDFPublished from pages 1–11 of the recorded source chapter.
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