David Hartzok, OD Print
(The presentation was made by Glenn Hagele on behalf of Dr. Hartzok)
9 I am making the
10 statement on behalf of Dr. David Hartzok and
11 Barbara Berney, co-founders of the Vision
12 Surgery Rehab Network.
13 The Vision Surgery Rehab Network,
14 VSRN, is a 501(c)(3) nonprofit organization
15 whose purpose is to help patients with
16 complications from any surgery that alters the
17 refractive status of the eye.
18 The bulk of our work focuses on
19 LASIK patients. We define their condition as
20 refractive surgery syndrome, RSS, a complex,
21 chronic visual, psychological and
22 physiological symptoms following any surgery

Page 32

1 that affects the refractive effects of the
2 eye.
3 This Panel must be prepared to hear
4 the extremes of two sides of an ongoing
5 argument, those who maintain that LASIK does
6 not generate depression and other
7 psychological issues versus those who argue
8 strenuously that their lives have been
9 irretrievably harmed.
10 VSRN believes that both extremes
11 are at times disingenuous in their arguments
12 and unnecessarily defiant in their
13 perspective. It is our hope that the
14 definition of refractive surgery syndrome
15 and, in particular, its psychological
16 components will be recognized and accepted by
17 the FDA, and that this definition will be a
18 starting point toward dialogue between the two
19 perspectives.
20 Physical, physiological and
21 psychological symptoms following LASIK may
22 combine to produce varying degrees of RSS. A

Page 33

1 common complaint of LASIK, dry eye, may be
2 thought of as a physical symptom, dryness,
3 burning or pain, that may have physiological
4 attributes relative to an inadequate tear
5 film, which creates a psychological awareness
6 of reduced vision.
7 As a contributing factor to RSS,
8 physical dryness can be an intractable
9 condition. The other end of the RSS spectrum
10 is less tangible and leads to most of the
11 post-surgery frustrations. VSRN contends that
12 vision as a perception is more complex than
13 LASIK advocates acknowledge.
14 Vision, as described in so many
15 studies and post-operative accounts,
16 concentrates heavily on the measurable optical
17 attributes of the eye's condition. While
18 knowledge of the refractive components of the
19 eye has grown, there has been no proportionate
20 increase in understanding how the alteration
21 of the eye's optical elements adversely affect
22 perception. Clearly, a broader perspective is

Page 34

1 needed.
2 Vision abnormalities induced by
3 LASIK are perceptual in a way that existing
4 technology cannot discern. LASIK has elicited
5 the gamut of subjective response from euphoric
6 elation to panicked angst. While newer
7 technology may be safer and more effective
8 than in the past, even today's advanced
9 procedures can reduce visual quality.
10 Our world, our reality, is the
11 summation of all of our perceptions, vision
12 being the most powerful. VSRN's experience
13 with patients is that LASIK alters their
14 reality in ways that disrupt their sense of
15 normalcy and well-being.
16 LASIK is an elective procedure. It
17 is natural for providers to downplay negative
18 outcomes, particularly when there is no
19 causative effect.
20 Too frequently, patients'
21 frustrations are compounded by denial of the
22 complaints by surgeons and other post-surgery

Page 35

1 examiners. They begin to believe that denial
2 is systemic in the industry and that their
3 doctors are uncaring.
4 Those feelings, combined with
5 aggressive marketing and inadequate informed
6 consent agreements exacerbate the
7 psychological aspects of RSS. Patients'
8 visual perceptions should be validated, not
9 denied.
10 The loss of visual quality reduces
11 patients' overall sense of well-being and
12 leads to depression and chronic anxiety. How
13 doctors manage LASIK problems is just as
14 critical to their patients' recovery as the
15 optical outcome. Any sense of non-caring
16 creates additional stress for the patient.
17 The visual complications of LASIK
18 suggest that certain properties in curvatures
19 of the cornea are unique to the individual and
20 may not be subject to generalized nomographic
21 approach.
22 Even Wavefront analysis, while

Page 36

1 elegant and attractive, fails to guarantee a
2 satisfactory surgical result. Patients with
3 Wavefront customized surgeries regularly
4 contact VSRN for help with RSS.
5 Rigid gas permeable contact lenses
6 and additional surgeries are the most common
7 rehab options. Informed consent agreements
8 fail to mention that neither is consistently
9 satisfactory nor successful. Patients whose
10 rehab efforts fail to restore normal vision
11 suffer a proportionately higher degree of RSS.
12 The number of patients affected is
13 incalculable, since successful LASIK, in the
14 surgeon's view, is procedural -- you are 20/20
15 -- while success of LASIK in the patient's
16 view is perceptual -- but it's not clear.
17 RSS will continue to remain under18
reported until the doctor versus patient
19 discrepancy is resolved. VSRN believes that
20 refractive surgery syndrome results in quality
21 of life issues for a significant but unknown
22 number of patients.

Page 37
1 Any meaningful investigation of the
2 quality of life after LASIK must be impartial,
3 undertaken by behavioral and perceptual
4 specialists with no vested interest in the
5 outcome. Thank you.
6 Those are the words of Barbara
7 Berney and David Hartzog.