Consent

"Several years earlier, when radial keratotomy (RK)—a procedure to change the shape of the cornea and allow nearsighted people to “throw away” glasses—was new, Waring had pioneered a study to be sure it would be safe for patients to undergo. Then and now, any surgeon in the country could try any new operation he wanted, as long as the patient could be talked into being a guinea pig and the hospital allowed it. Federal regulations for evaluating new surgical procedures do not exist as they do for new drugs."

Dr Tom Harbin, 'Waking up Blind' - 2009

"Minerva raised the question of whether radial keratotomy is a really worthwhile advance? Firstly, it works up to only a maximum of -6D of myopia, and then unpredictably. Up to -3D it works very well, but why throw away the precious gift of being able to read fine print with the naked eye, a boon that comes to all low myopes with the onset of presbyopia? One wonders just how informed is the consent given by these low myopes.  What radial keratotomy has done is to focus the profession's attention on the visual  dissablement, the impairment of lifestyle, and the lack of self esteem of the really high myope.

Radial keratotomy is made to measure for capitalist society (ironically inspired by a leading Soviet surgeon); it cannot be denied that thereby fortunes have been made by radial keratotomists and by the suppliers of the necessary instrumentation."

D P Choyce, BMJ - 1985

"Returning to the issue of informed consent, the level of risk that an individual will accept before undergoing an elective procedure is patient-specific. As part of the informed consent process, he or she should be told of the risks of undercorrection and overcorrection, glare, diurnal fluctuation, infection, progressive effect (hyperopic shift), globe rupture, loss of best-corrected visual acuity, and other factors associated with the various surgical options. While we cannot quote exact numerical risks, we can tell our prospective patients that they maybe at increased risk of globe rupture for at least a decade after surgery, and they should therefore take reasonable precautions."

Peter J. McDonnell MD, Sight-Threatening Complications After Radial Keratotomy , Arch Ophthal, Feb 1996


 PERK Informed Consent - 1980


"Furthermore patients need to be made aware of common complications such as fluctuating vision and starburst pattern of glare, as well as vision-threatening complications such as keratitis, endophthalmitis, cataract, and irregular astigmatism."

Dr Charles Casebeer, Incisional Keratotomy - 1995

Toronto Consent Form - 1993


"Furthermore, patients should be told that the final effect of this procedure on an individual eye cannot be predicted with certainty, and that the result may not stabilize for several years.  The possibility of inducing hyperopia, and the implications of induced hyperopia should be explained. It may be helpful to over-minus a patient under cycloplegic conditions in order to demonstrate how induced hyperopia in a presbyopic state will affect distance and near vision as the patient grows older.  Each patient should be informed of the risk of permanent loss of one or more lines of vision, and of the rare possibility of loss of the eye. The patient should understand that this risk persists to some extent for an undetermined length of time after surgery. The informed consent should make the patient aware of potential uncertainties as well as complications associated with radial keratotomy."

Dr Walter J Stark, Anterior Segment Surgery - 1987

Sanders Consent -1985


"I then discuss the more common undesirable side effects of RK which include glare, fluctuations in vision, increased astigmatism, over- and under-corrections, permanent corneal scars, and instability. When I discuss over- and under-corrections, I demonstrate with trial lenses the most likely amount of myopia reduction for their age as well as several examples of both over and under-corrections."

Dr Frank B Thompson, Myopia Surgery - 1990

Sanders Consent - 1986


"As a result of the surgery, it is possible that my vision may be made worse. This could happen as a result of infection that could not be controlled with antibiotics or other means, in which case it-may be possible that the eye could be lost.  This could also occur due to irregular healing of the incisions such that the corneal surface would be distorted. I understand that, in that case, it may be necessary for me to wear a contact lens to effect useful vision and that this may not restore useful vision.

I understand that glare with night driving, halos around headlights, and star-shaped figures around lights occur after surgery. Usually these conditions go away with time. However it is possible that they can persist indefinitely.   Fluctuating vision different vision at different times of day) occurs after surgery. This condition usually disappears with time. However, it may persist to some degree indefinitely.  If for any reason, the second eye is not operated on and is not fitted with a contact lens, double vision with glasses may persist and cause vision problems.  This condition is usually worse in cases of higher myopia."

Dr Leo Bores, Goodbye Glasses - 1990

Bores Consent - 1990

Thompson Consent - 1990

Thornton Consent-1994

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Waring Consent - 1992

Casebeer Consent - 1995