RESEARCH ARTICLE

Stability of Laser-Assisted In Situ Keratomileusis

(LASIK) at Altitude
Michelle Aaron, Steve Wright, John Gooch,
Rich Harvey, Ryan Davis, and Charles Reilly

AARON M, WRIGHT S, GOOCH J, HARVEY R, DAVIS R, REILLY C. Stability

measurements. A U.S. Air Force study used a hypo-
of laser-assisted in situ keratomileusis (LASIK) at altitude. Aviat
baric chamber to simulate altitude at two flight profiles:
Space Environ Med 2012; 83:958–61.
10,000 ft (3048 m) for 12 h without supplemental oxygen
Background: The U.S. Air Force approved laser-assisted in situ ker-
and 35,000 ft (10,668 m) for 30 min with supplemental
atomileusis (LASIK) for aircrew in May 2007. Relative to photorefractive
keratectomy (PRK), LASIK potentially offers a more rapid return to flight
oxygen. Under both conditions, no changes in refrac-
status; however, there are concerns regarding corneal stability at altitude
tion, keratometry, or visual performance were observed
after surgery. Studies have shown that hypoxia induces a myopic shift in
relative to pre-exposure levels (13).
LASIK eyes. Mountaineers treated with LASIK have similarly reported
Studies on the effects of altitude after laser-assisted
decreased distance acuity when climbing above 22,000 ft (6706 m). We
in situ keratomileusis (LASIK) have been more equivocal.
evaluated visual and refractive stability after LASIK under conditions simu-
lating an operational aviation mission. Methods: There were 24 eyes of
Exposure of post-LASIK eyes to hypoxia using nitrogen-
12 active duty subjects that were examined 1 or more months after LASIK.
filled goggles over a 2-h period demonstrated a clinically
Measurements of high and low contrast visual acuity, keratometry, and
small, but statistically significant, myopic shift of 20.31 D
refractive error were performed at ground level after a 2-h oxygen pre-
relative to nonsurgical eyes (8). A U.S. Navy study using
breathe and repeated after 30 min of exposure to conditions simulating
35,000 ft (10,668 m) using a hypobaric chamber. A within subject, repeated
goggles exposed LASIK eyes to hypoxia and low rela-
measures t-test was used to compare findings at altitude to ground level.
tive humidity that simulated 25,000 ft (7620 m) for 2.5 h
Results: LASIK eyes demonstrated no clinically or statistically significant
(12). No changes in refraction or visual acuity were mea-
changes at altitude relative to ground level for the four parameters stud-
sured. It should be noted, however, that both of these
ied. No eyes showed more than 60.25 D of change on keratometry and
none had a myopic shift greater than 0.25 D. Conclusion: LASIK eyes
studies were limited to hypoxia without the accompany-
exposed to extreme altitudes under operational conditions, where the
ing hypobaria that occurs with true altitude exposure.
exposure is limited to 30 min or less, are expected to remain stable.
Keywords: LASIK, altitude, hypoxia, hypobaria. A study performed by two physician climbers dem-
onstrated a measurable decline in distance visual acuity
during a 2-wk ascent of Aconcagua, Argentina (22,841
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20 Jul 2018 12:53:32
C ORNEAL REFRACTIVE surgery (CRS) has
adopted by all branches of the U.S. military for
been
treat- rected
Delivered by Ingenta
ment of ametropic aircrew. While this potentially elimi-
m), after
Copyright: Aerospace Medical Association
distance
LASIK (1). Both started with uncor-
visual acuities of 20/20 at sea level
that degraded to 20/125 and 20/160 at altitude. These
nates many of the operational liabilities associated with changes were presumed to be secondary to a myopic shift;
spectacle and contact lens use in the cockpit (7,9), his- however, measurement of refractive error was not per-
torical experience has demonstrated that CRS potentially formed as part of the study. By contrast, six climbers
renders the post-surgical cornea unstable when exposed ascending Mt. Everest (29,029 ft/8848 m) after LASIK
to altitude. This would clearly raise concerns for military reported that five of the six maintained 20/20 uncorrected
aviators who may routinely be exposed to such conditions. acuity at 17,600 ft (5364 m) (the sixth was measured at
Changes in refractive error secondary to altitude 20/30) and four of the climbers reached the summit with-
exposure after CRS were first noted by mountaineers out significant vision changes (3). The fifth completed the
ascending above 10,000 ft (3048 m) following radial ker- ascent, but reported generally milky vision that impaired
atotomy (RK). After 24 h of exposure, a visually significant distance and near vision equally, and the sixth was forced
hyperopic shift was observed that would slowly regress to abandon the attempt due to similarly impaired vision.
upon descent (2). A study of RK subjects by Mader on
Pike’s Peak (14,100 ft/4298 m) quantified a mean hyper- From the U.S. Air Force School of Aerospace Medicine, Ophthalmology
opic shift of 1.52 D, range 20.25 D to 13.50 D, after 72 h Branch, Wright-Patterson AFB, OH, and the Joint Warfighter Refrac-
of exposure (5). tive Surgery Center, Lackland AFB, TX.
This manuscript was received for review in January 2012. It was
The first excimer laser refractive surgery technique accepted for publication in May 2012.
approved by the U.S. military, photorefractive keratec- Address correspondence and reprint requests to: Dr. Steven T. Wright,
tomy (PRK), was thoroughly studied under both simu- USAFSAM/FECO, 2510 5th St., Wright-Patterson AFB, OH 45433-7913;
lated and real-life altitude conditions. Mader ’s study steven.wright2@wpafb.af.mil.
Reprint & Copyright © by the Aerospace Medical Association,
demonstrated refractive and keratometric (corneal cur- Alexandria, VA.
vature) stability in PRK subjects relative to sea-level DOI: 10.3357/ASEM.3325.2012

958 Aviation, Space, and Environmental Medicine x Vol. 83, No. 10 x October 2012
LASIK ALTITUDE STUDY—AARON ET AL.
As was observed with RK, all of the changes associated
with the Aconcagua and Everest climbs regressed upon
descent to sea level.
Corneal instability after RK is not of particular concern
for U.S. military aviation, as it was never an approved
procedure for aircrew and has become effectively obso-
lete with the introduction of the excimer laser. Instabil-
ity after LASIK, however, is highly relevant, as both the
U.S. Army and U.S. Air Force (USAF) offer this proce-
dure for aircrew regardless of crew position and the
risk of exposure to altitude. The U.S. Navy is currently
performing studies to evaluate the safety and efficacy
of LASIK for aviators.
It is currently unknown whether post-LASIK corneas
may experience refractive shifts secondary to altitude
exposure in an operational environment. Aircrew par-
ticipating in missions such as a high-altitude low-opening
drop may be exposed to conditions as high as 35,000 ft
(10,668 m), albeit for a duration of minutes to hours
rather than days. This study was intended to bridge this
gap in the research by investigating refractive, corneal,
and visual stability in post-LASIK subjects when exposed
to conditions simulating a high altitude mission profile.
METHODS
Subjects
Included in this study were 12 active duty USAF mem-
bers (24 eyes) who had undergone femtosecond LASIK
for correction of myopia at least 1 mo prior. Informed
consent was obtained from each individual and the
protocol was reviewed and approved by the Wright-
Patterson Air Force Base (AFB) Institutional Review
Board (Protocol # F-BW-2008-0003H). Subjects were ad-
vised of the risks of altitude exposure in the informed
consent process and, if not previously chamber qualified
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as part of their military duties, were required to complete
Fri,
Copyright: Aerospace
a 1-d didactic course related to altitude chamber safety.
Subjects were composed of eight men and fourDelivered
women by Ingenta
with an average age of 34 yr (range 21 to 50) and a mean
spherical equivalent preoperative refractive error of
23.71 D (range 21.13 D to 25.75 D). Evaluations were
performed an average of 2.6 mo after surgery (range 1 to
6) and all surgical procedures were performed using the
VISX Star S4 at Wilford Hall Medical Center, Lackland
AFB, TX, with femtosecond flap creation. Exclusion cri-
teria for the study included intraoperative or postopera-
tive complications and current or previous ocular or
systemic disease that would contraindicate hypobaric
exposure. Subjects were also restricted from hyperbaric
(e.g., scuba diving) and hypobaric (e.g., flying) exposure
72 h prior to study.
Examinations
Four parameters associated with vision and refraction
were studied: high and low contrast visual acuity, re-
fractive error, and keratometry. Visual acuity was mea-
sured using Precision Vision (La Salle, IL) high and low
(5%) contrast charts in a rear-illuminated light box.
Testing was performed at 13 ft (4 m) under full room
Aviation, Space, and Environmental Medicine x Vol. 83, No. 10 x October 2012
illumination, which was necessary for safety reasons,
yielding a chart luminance of 180 Cd z m22 (similar to
viewing a computer monitor when a white screen is
displayed) and Weber contrasts of 98% and 11%, respec-
tively. Scores were based on the total number of letters
correctly identified, without penalty for errors, and con-
verted to logMAR units with each letter valued at 0.02
logMAR. Subjects were tested monocularly using habit-
ual correction.
Refractive error and keratometry were assessed us-
ing a handheld Nikon Retinomax K-Plus auto refract-
keratometer (Melville, NY- item no longer manufactured),
which provides an objective measure of refractive status
in 0.25 D increments and central corneal curvature in
0.125 D increments. Three measurements were taken for
each eye and the measurement that represented the me-
dian finding was kept for analysis. Spherical equivalent
refractive error was determined by taking the mean of
the two refractive axes, while a single value for keratom-
etry measurements was similarly determined.
Baseline examinations at ground level were performed
on subjects after a 2-h prebreathe of 100% oxygen. Subjects
then ascended to 35,000 ft (10,668 m/3.46 psia) in a hypo-
baric chamber at a rate of 5000 ft z min21 (1524 m z min21)
while continuing the oxygen breathe. After 30 min at
altitude, examinations were repeated. The delivery of
oxygen was through a standard USAF aircrew breathing
mask, which provides systemic oxygen but does not
oxygenate the cornea.
Data Analysis
A repeated measures t-test at the 95% confidence level
(SPSS, Chicago, IL) was used to statistically relate base-
line to altitude findings. Right and left eye data were as-
sessed independently to account for correlation between
two
eyes
20 Jul of a12:53:32
2018 subject, which would lead to artificially
Medical
high Association
levels of precision (6,10).
RESULTS
Refractive status and corneal curvature at ground
level and altitude are reported in Table I. A small hyper-
opic shift was observed in right eye data that was neither
clinically nor statistically significant. There were no
changes to mean levels of refractive error within left eye
data. Overall, 22 of the 24 eyes were within 60.25 D at
altitude relative to their baseline status and the remain-
ing two eyes (two subjects) demonstrated hyperopic
shifts of 0.50 D and 0.75 D. Keratometric data demon-
strated subtle central corneal flattening with each eye;
however, again, this was not a clinically or statistically
significant finding. No eyes showed more than 60.25 D
change at altitude relative to ground level findings.
High and low contrast acuities, reported in Table II,
also showed minimal changes between baseline and al-
titude conditions. On average, acuities at altitude were
one letter better than measured at baseline, a finding that
was neither statistically nor clinically significant. Two
eyes (one subject) gained one line of acuity (five letters)
on high contrast testing and three eyes (two subjects)
959
LASIK ALTITUDE STUDY—AARON ET AL.
TABLE I. REFRACTIVE ERROR AND CORNEAL CURVATURE
AT BASELINE AND ALTITUDE.
Test Eye* Baseline (Ground) 35K ft
Refractive Error OD 20.52 6 0.31 20.44 6 0.32
OS 20.40 6 0.39 20.40 6 0.29
Keratometry OD 40.51 6 2.11 40.47 6 2.10
OS 40.50 6 2.21 40.47 6 2.21
Mean 6 1 SD in dioptric units. All P . 0.05. * OD 5 right eye; OS 5 evaluated four parameters of refractive and visual per-
left eye.
showed a similar change on low contrast testing. However,
no eyes demonstrated a gain on both tasks, suggesting
that these changes were not related to any experimental
effect. No eyes showed a loss of one or more lines of
acuity on either task.
DISCUSSION
Corneal refractive surgery may offer operational and
readiness benefits for military aircrew; however, prior
experience and research has demonstrated that some
refractive procedures may render the cornea unstable
when exposed to altitude. Winkle has shown that these
changes are primarily due to corneal hypoxia (14) rather
than hypobaria, as the cornea relies on atmospheric oxy-
gen for metabolism (4). When the cornea becomes hy-
poxic, the tissue thickens, leading to mechanical stresses
to the normal shape (11). After RK, the peripheral tissue of
the cornea is selectively weakened, leading to increased
peripheral thickening with associated central flattening
and a hyperopic shift. After LASIK, the central corneal
tissue is selectively weakened, potentially leading to
central thickening, central steepening, and an associated
myopic shift.
Corneal instability at altitude after LASIK is of particu-
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lar interest to military aviation, as both the U.S. Army
Copyright: Aerospace Medical Association
and U.S. Air Force currently offer the procedureDelivered to am- bycornea
etropic aircrew, which is a larger population than might
be envisioned. A 2010 study of USAF aviators reported
that 47% of all aircrew, including 41% of pilots, required
corrective lenses to meet flying standards and over 2200
aircrew were on flying status after CRS (15). The major-
ity of these treatments have been PRK (92%), in part due
to the fact that the USAF did not approve LASIK for air-
crew until 2004 and due to concerns about post-LASIK
flap stability in the aerospace environment. However,
LASIK may become more prevalent in the future, as it
offers the advantage of more rapid healing and, thus, a
potentially shorter period of grounding after the proce-
TABLE II. HIGH AND LOW CONTRAST ACUITY AT BASELINE AND ALTITUDE.
Test Eye*
High Contrast OD
OS
5% Contrast OD
OS
Mean 6 1 SD in LogMAR units with Snellen equivalent of mean in parenthesis. All P . 0.05. * OD 5 right eye; OS 5 left eye.
960
dure. Additionally, the use of femtosecond lasers to cre-
ate the LASIK flap may improve the safety profile of the
procedure.
Studies on the effects of hypoxia and corneal stability
after LASIK have been equivocal. Some have reported
visually significant myopic shifts with resulting impair-
ment of distance vision, while others have reported little
or no changes when experiencing similar conditions. We
formance on post-LASIK eyes following 30 min of expo-
sure to conditions simulating 35,000 ft (10,668 m). No
significant changes to central corneal shape, refractive error,
or visual acuity were observed relative to pre-exposure
levels.
Keratometric measurements on all eyes at altitude were
within 60.25 D of baseline findings and 22 of 24 eyes
were within 60.25 D of baseline based on refractive error.
Visual acuity also demonstrated stability with a difference
of only one letter on high and low contrast tasks at altitude
relative to baseline measurements. While our P-values
were sufficient to reject the alternative hypothesis (i.e.,
reject the hypothesis that significant changes were ob-
served), it should be noted that effect sizes were low to
moderate based on the variable being analyzed, indicat-
ing that a larger sample size would be required to un-
equivocally rule out the possibility of corneal instability
at altitude after LASIK. Our sample size was small due
to the fact that the experimental conditions represented
greater than minimal risk to study subjects. Thus, we
chose not to include a control group of nonsurgical eyes
and evaluated the minimum number of subjects thought
to be needed to achieve statistical significance. These de-
cisions proved to be well founded as the 12th subject did
suffer a significant decompression event that required
emergent medical care.
There are numerous factors that may explain why in-
stability is not universally observed when the post-LASIK
Ingenta is exposed to altitude. No studies have been per-
formed that have controlled for clinical parameters such
as corneal pachymetry, LASIK flap thickness, postoper-
ative corneal curvature, patient age, or preoperative re-
fractive error. Experience with RK indicated that at least
24 h of exposure were required before changes would
occur; however, Nelson (8) demonstrated refractive
changes after LASIK after only 2 h of hypoxia. We did
not intend to address many of these questions, but
rather to evaluate what the post-LASIK military aviator
might experience when exposed to altitude within the
scope of a specific mission scenario. We did not observe
any findings that would suggest short-term exposure to
Baseline (Ground) 35K ft
20.045 6 0.079 (20/18.0) 20.063 6 0.073 (20/17.3)
20.062 6 0.125 (20/17.4) 20.075 6 0.103 (20/16.8)
10.328 6 0.131 (20/42.6) 10.305 6 0.117 (20/40.4)
10.312 6 0.168 (20/41.0) 10.280 6 0.153 (20/38.1)
Aviation, Space, and Environmental Medicine x Vol. 83, No. 10 x October 2012
LASIK ALTITUDE STUDY—AARON ET AL.
extreme altitudes will be a problem for an aircrew mem-
ber previously treated with LASIK.
No significant changes to corneal curvature, refrac-
tive error, or visual performance were observed among
post-LASIK subjects after 30 min of exposure to hypoxic
conditions simulating an altitude of 35,000 ft (10,668 m).
Our study suggests that LASIK eyes exposed to extreme
altitude under operational conditions, where the expo-
sure time is limited, are expected to remain stable. How-
ever, the study sample size was limited due to subject
risk and a larger study would be required to fully rule
out this possibility.
ACKNOWLEDGMENT
We would like to thank Mr. Jared Haynes for providing statistical
guidance and review for this paper as well as Ms. Sandy Kawano for
her editorial review.
Authors and affiliations: Michelle Aaron, O.D., Ph.D., John Gooch,
M.D., Steve Wright, O.D., M.S., Rich Harvey, M.D., and Ryan Davis,
M.D., U.S. Air Force School of Aerospace Medicine, Ophthalmology
Branch, Wright-Patterson AFB, OH, and Charles Reilly, M.D., Joint
Warfighter Refractive Surgery Center, Lackland AFB, TX.
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