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JUNE 2008 I CATARACT & REFRACTIVE SURGERY TODAY I 55
COVER STORY
Two ophthalmic societies and two federal
agencies have formed a joint task force to
look beyond the safety and efficacy of
LASIK—which has been well established in
clinical trials—to the procedure’s impact on patients’
ability to perform their daily activities. The Joint LASIK
Study Task Force includes representatives from the
ASCRS, the AAO, the National Eye Institute, and the
FDA. The study of quality of life is a relatively new
field, and few LASIK clinical trials to date have includ-
ed measurements of this parameter. In a review of the
literature, Kerry Solomon, MD, a co-chair of the task
force, identified 19 studies that measured patients’ sat-
isfaction. In those studies, 95.4% of 2,200 patients said
they were satisfied or very satisfied with LASIK. This
figure compares favorably with similar reviews in other
elective cosmetic surgical fields, but satisfaction is only
one element of quality of life. The task force has pro-
posed a large, multicenter, prospective study in an
effort to improve the care of LASIK patients.
THE BEGINNING
The Joint LASIK Study Task Force was initiated
approximately 1.5 years ago in response to complaints
sent to the FDA and Congress by dissatisfied LASIK
patients. In November 2006, the FDA approached the
ASCRS, AAO, and National Eye Institute about conduct-
ing a postapproval LASIK quality-of-life study. The presi-
dent and president elect of the ASCRS at the time,
Samuel Masket, MD, and Richard L. Lindstrom, MD,
respectively, became engaged in the effort. Dr. Solomon
undertook a comprehensive review of the world litera-
ture on satisfaction after LASIK. I also joined the task
force and was the chair of the Protocol Development
Subcomittee for the proposed study.
THE PROPOSED STUDY
Many of the study’s details are still being developed,
but the goals are to (1) assess the level of satisfaction
after LASIK, (2) evaluate changes in quality of life after
surgery, and, most importantly, (3) identify preopera-
tive factors associated with postoperative satisfaction
and quality of life. We hope that the outcomes of the
potential study will help us refine the methods we use
to screen patients and recommend additional counsel-
ing to improve the informed consent process, thereby
reducing the chance that patients will be dissatisfied
with the outcomes of LASIK.
We refractive surgeons want to meet or exceed the
expectations of all LASIK patients and improve their
quality of life. We hit this target in almost everyone we
Identifying
Potentially Unhappy
LASIK Patients
The Joint LASIK Study Task Force is working to identify preoperative factors that may have
an impact on patients’ satisfaction and quality of life after LASIK.
BY STEVEN C. SCHALLHORN, MD
“We refractive surgeons want to
meet or exceed the expectations of
all LASIK patients and improve their
quality of life.”
treat. Dr. Solomon’s review of the literature, however,
suggests that we could do better in approximately 5%
of LASIK patients.
From previous research, we have identified some risk
factors for dissatisfaction after LASIK, including subopti-
mal visual acuity, dry eyes, and night vision symptoms.1-4
Advances in our understanding of these issues and im-
provements in laser technology, surgical techniques, and
postoperative medications have made significant ad-
vances in our ability to alleviate post-LASIK problems.
There is more to the story, however. Some LASIK patients
may be satisfied with their outcomes, whereas others
who have the same level of ocular dryness could be very
upset and describe the condition as compromising their
quality of life. The dissimilarity between these patients is
likely multifactorial, such as different expectations,
lifestyles, coping skills, and personality traits.
We still do not have a thorough understanding of
how psychological factors affect patients’ satisfaction
with LASIK, although unpublished research by the
Navy showed that preoperative levels of depression
and negativity are independently associated with dis-
satisfaction. These outcomes are not surprising,
because this association has been demonstrated with
other types of elective procedures. This association
points to other factors, however, completely unrelated
to the surgery or surgical outcome that need to be
considered when trying to understand why some
patients are dissatisfied. The proposed study will eval-
uate some of these psychological issues.
Another possible area of focus for the study is the
informed consent process, especially as it relates to the
patient expectations postoperatively. In some sense,
we are the victims of our own success. As the results
of refractive surgery improve, patients’ expectations of
excellent outcomes also increase. When these out-
comes are coupled with an inherently high level of sat-
isfaction among patients, there is an expectation that
everyone will achieve a satisfactory result. Patients can
be dissatisfied after surgery, however, if their personal
expectations are not achieved. Understanding these
expectations and how best to counsel patients in this
regard is an area where further study is needed.
CONCLUSION
Conducted with due diligence by all involved, I have
no doubt that the proposed study will benefit both
patients and surgeons and will further improve LASIK,
a procedure that has already enhanced the vision and
quality of life of millions of people. ■
Steven C. Schallhorn, MD, is in private prac-
tice in San Diego. He is a consultant to
AcuFocus, Inc. andAdvanced Medical
Optics, Inc. Dr. Schallhorn may be reached at
scschallhorn@yahoo.com
1. Hill JC. An informal satisfaction survey of 200 patients after laser in situ keratomileusis.
J Refract Surg
. 2002;18:454-459.
2. Schmidt GW, Yoon M, McGwin G, et al. Evaluation of the relationship between ablation
diameter, pupil size, and visual function with vision-specific quality-of-life measures after
laser in situ keratomileusis.
Arch Ophthalmol.
2007;125:1037-1042.
3. Levinson BA, Rapuano CJ, Cohen EJ, et al. Referrals to the Wills Eye Institute Cornea
Service after laser in situ keratomileusis: reasons for patient dissatisfaction.
J Cataract
Refract Surg.
2008;34:32-39.
4. Jabbur NS, Sakatani K, O’Brien TP. Survey of complications and recommendations for
management in dissatisfied patients seeking a consultation after refractive surgery.
J Cataract
Refract Surg.
2004;30:1867-1874.
56 I CATARACT & REFRACTIVE SURGERY TODAY I JUNE 2008
COVER STORY
“We have identified some risk factors
for dissatisfaction after LASIK,
including suboptimal visual acuity,
dry eyes, and night vision symptoms.”
