FDA statement-Refractive Surgery Syndrome

Below is the text of VSRN's statement to the FDA. Other statements will be posted to this thread as I am able to do so.


LASIK: Quality of Life Issues
Presentation to the FDA Ophthalmic Devices Panel

April 25, 2008

David L. Hartzok, OD, FAAO, Exectutive Director
Barbara Berney, President
Vision Surgery Rehab Network, NFP
www.visionsurgeryrehab.org

The Vision Surgery Rehab Network (VSRN) is a 501(c)(3) non-profit organization whose purpose is to help patients with complications from any surgery that alters the refractive status of the eye. The bulk of our work focuses on LASIK patients. We define their condition as Refractive Surgery Syndrome (RSS): a complex of chronic visual, physiological and/or psychological symptoms following any surgery that affects the refractive elements of the eye.

This panel must be prepared to hear the extremes of two sides of an ongoing argument; those who maintain that LASIK does not generate depression and other psychological issues versus those who argue strenuously that their lives have been irretrievably harmed. VSRN believes that both extremes are, at times, disingenuous in their arguments and unnecessarily defiant in their perspective. It is our hope that the definition of Refractive Surgery Syndrome and, in particular, its psychological components, will be recognized and accepted by the FDA and that this definition will be a starting point toward a dialogue between the two perspectives.

Physical, physiological and/or psychological symptoms following LASIK may combine to produce varying degrees of RSS. A common complication of LASIK, dry eye, may be thought of as a physical symptom (dryness, burning or pain) that may have physiological attributes relative to an inadequate tear film, which create a psychological awareness of reduced vision. As a contributing factor to RSS, physical dryness can be an intractable condition.

The other end of the RSS spectrum is less tangible and leads to most of the post-surgery frustrations. VSRN contends that vision, as a perception, is more complex than LASIK advocates acknowledge. Vision, as described in so many studies and post-operative accounts, concentrates heavily on the "measurable" optical attributes of the eye’s condition. While knowledge of the refractive components of the eye has grown, there has been no proportionate increase in understanding how the alteration of the eye’s optical elements adversely affects perception. Clearly, a broader perspective is needed. Vision abnormalities induced by LASIK are perceptual in a way that existing technology cannot discern.

LASIK has elicited the gamut of subjective response from euphoric elation to panicked angst. While newer technology may be safer and more effective than in the past, even today’s advanced procedures can reduce visual quality. Our world – our reality – is the summation of all of our perceptions, vision being the most powerful. VSRN’s experience with patients is that LASIK alters their reality in ways that disrupt their sense of normalcy and well-being.

LASIK is an elective procedure; it is natural for providers to downplay negative outcomes, particularly when no causal factor is evident. Too frequently, patients’ frustrations are compounded by denial of their complaints by surgeons or other post-surgery examiners. They begin to believe that denial is systemic in the industry and that their doctors are uncaring. Those feelings, combined with aggressive marketing and inadequate informed consent agreements, exacerbate the psychological aspects of RSS. Patients’ visual perceptions should be validated, not denied.

The loss of visual quality reduces patients’ overall sense of well-being and leads to depression and chronic anxiety. How doctors manage LASIK problems is just as critical to their patients’ recovery as the optical outcome. Any sense of non-caring creates additional stress for the patient.

The visual complications of LASIK suggest that certain properties and curvatures of the cornea are unique to the individual and may be not subject to a generalized, nomographic approach. Even wavefront analysis, while elegant and attractive, fails to guarantee a satisfactory surgical result. Patients with wavefront-customized surgeries regularly contact VSRN for help with RSS.

Rigid gas permeable contact lenses and additional surgeries are the most common rehab options. Informed consent agreements fail to mention that neither is consistently satisfactory, nor successful. Patients whose rehab efforts fail to restore normal vision suffer a proportionately higher degree of RSS.

The number of patients affected is incalculable, since successful LASIK in the surgeon's view is procedural (You’re 20/20!), while successful LASIK in the patient's view is perceptual (…but it’s not clear!). RSS will continue to remain underreported until the doctor versus patient discrepancy is resolved. VSRN believes that Refractive Surgery Syndrome results in quality of life issues for a significant, but unknown, number of patients. Any meaningful investigation of quality of life following LASIK must be impartial, undertaken by behavioral and perceptual specialists with no vested interest in the outcome.
Original Post

The outcome of that meeting in 2008 was the LASIK quality of life study, an overview of results of which have been published on the VSRN website here. There is a link at the bottom of that page that will take you to the actual study. The questionnaires are also available on the VSRN website here. Links are included on that page.

As a member of the Steering Committee for that study, I found it problematic.

Artistwoman posted:

The outcome of that meeting in 2008 was the LASIK quality of life study, an overview of results of which have been published on the VSRN website here. There is a link at the bottom of that page that will take you to the actual study. The questionnaires are also available on the VSRN website here. Links are included on that page.

As a member of the Steering Committee for that study, I found it problematic.

Hi thank you for the reply. I am glad that you answered so quickly. 

What exactly did you find problematic?

thanks

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