Exposing the LASIK Scam

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 Post subject: Pupil size
PostPosted: Sat May 13, 2006 5:09 pm 
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The FDA says that patients with large pupils are poor candidates for LASIK.

http://www.fda.gov/cdrh/LASIK/reduce.htm

Quote:
Know what makes you a poor candidate

Career impact - does your job prohibit refractive surgery?

Cost - can you really afford this procedure?

Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?

Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?

Medications - do you take steroids or other drugs that might prevent healing?

Stable refraction - has your prescription changed in the last year?

High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?

Pupil size - are your pupils extra large in dim conditions?

Corneal thickness - do you have thin corneas?

Tear production - do you have dry eyes?



The FDA approves the "labeling" for lasers used in refractive surgery. The labeling includes a patient information booklet (PIB). The FDA requires that patients be given this booklet prior to making a decision about LASIK (many surgeons fail to comply with this mandatory requirement). The PIB has warnings regarding large pupils.

If anyone needs assistance locating the FDA labeling for a particular laser, please contact me and I will locate it for you.

In addition, the Federal Trade Commission (which regulates LASIK advertising), the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgeons, and the medical malpractice insurer OMIC, all have taken positions against doing LASIK on patients with large pupils.

There is a huge body of evidence in the scientific literature (peer-reviewed) going back to the early days of refractive surgery that proves the importance of pupil size. I have boxes full of it. Contact me if you need help locating this type of evidence. There is just a handful of poorly designed studies that attempt to disprove the importance of pupil size. These studies are easily invalidated.

The standard of care is to take pupil size into account when planning the optical zone for refractive surgery and warning patients with large pupils of their increased risk of permanent, debilitating visual disturbances in low lighting. Surgeons who give a patient an optical zone smaller than his or her scotopic pupil size without informing the patient of the negative impact on vision fall below the standard of care.

There is objective testing available that proves patients with large pupils experience degradation of vision in dim light. Wavefront aberrometry shows visual aberrations increase with increasing pupil size. These tests should be done at the patient's scotopic pupil diameter. Any measurement taken at a smaller scan diameter does not reveal the degradation the patient is experiencing in dim light.

There are also many scientific papers on the proper method of measuring pupils for refractive surgery screening. I have these as well.

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sun May 14, 2006 1:18 am 
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http://www.mayoclinicproceedings.com/in ... =1262&UID=

Mayo Clin Proc. 2001 Aug;76(8):823-9.

Excerpts:

"Determination of pupil size in a darkened room is essential in the preoperative evaluation to identify patients who may be at risk of glare and halos after surgery. Patients with dark-adapted large pupils should be warned of the higher risk of postoperative visual distortion or glare in dark illumination."

"Medical contraindications to LASIK include a cornea that is too thin or eyes with corneal ectasia in association with irregular astigmatism. Ocular disease, including active collagen vascular disease, rheumatoid arthritis, central panstromal corneal scars, and active herpetic keratitis, contraindicates LASIK in most instances. Relative contraindications are moderate to severe dry eye, cataracts, severe diabetes, advanced or unstable glaucoma, severe anterior basement membrane dystrophy, and pupil size greater than the maximum available ablation optical zone of the laser to be used."

Several vision changes have been described following LASIK, including halos, glare, and ghosting of images. These visual changes occur most often in patients who have pupils that are larger than the ablation zone.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject: EOZ/pupil size mismatch a permanent record of malpractice
PostPosted: Mon May 15, 2006 1:02 pm 
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Pupils larger than the effective optical zone (the programmed full treatment zone excluding blend) allow unfocused light to enter the pupil, resulting in poor vision and GASH in dim light and should be banned.

Doctors who perform surgeries with inadequate zone sizes KNOW they are creating inadequate optical zones and should be held accountable for the inevitable PERMANENT visual loss that results.

A patient may receive a 'treatment' zone that is exacly the size of their pupil, but unless they are FULLY treated to the maximum size of their pupil, vision loss and visual trash in dim light is created by the surgeon.

Deterioration of the optics in the eye with increasing pupil size can be measured by taking wavefront scans at inreasing pupil diameters out to the patient's maximum pupil size.

All the eyes that have had surgeries with inadequate optical zones will serve as a permanent record of a surgeon's failure to ensure a proper zone size. The evidence of the inadequacy of the treatment is easily obtained (superimpose the topography taken from the doctor's own office with a digital snaphot of the ptient's maximum pupil size (hold a millimeter ruler underneath the lower lashes). Patients can do this at home.

Yes, optical zone/pupil size mismatches are easily imaged and understood by a jury, and are permanent - zone enlargements don't tend to work too well because of limitations of corneal thickness. If the patient had a thick cornea they may have received an adequate zone size to begin with. Doctors have no right to make compromises with something as vital as a patient's vision.

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We can easily forgive a child who is afraid of the dark. The real tragedy of life is when men are afraid of the light. -Plato


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 Post subject:
PostPosted: Tue Oct 16, 2007 6:56 pm 
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The FDA recently revised their warning about pupil size:

http://www.fda.gov/cdrh/lasik/when.htm

Quote:
Large pupils. Make sure this evaluation is done in a dark room. Although anyone may have large pupils, younger patients and patients on certain medications may be particularly prone to having large pupils under dim lighting conditions. This can cause symptoms such as glare, halos, starbursts, and ghost images (double vision) after surgery. In some patients these symptoms may be debilitating. For example, a patient may no longer be able to drive a car at night or in certain weather conditions, such as fog.

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Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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 Post subject:
PostPosted: Tue Oct 16, 2007 7:01 pm 
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I also located this on the FDA website:

http://www.fda.gov/womens/getthefacts/pdfs/lasik.pdf

Quote:
Things your doctor must look for before surgery

Your doctor needs to find out if you have any of these conditions:
? Past or current eye diseases, such as glaucoma and ocular hypertension
? Eye injuries or other laser eye surgery
? Large pupils, thin corneas, or dry eyes

_________________
Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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 Post subject:
PostPosted: Tue Oct 16, 2007 7:26 pm 
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LASIK and the importance of pupil size:

http://lasikflap.com/forum/viewtopic.php?t=19

http://lasikflap.com/forum/viewtopic.php?t=82

http://lasikflap.com/forum/viewtopic.php?t=1057

http://lasikflap.com/forum/viewtopic.php?t=850

http://lasikflap.com/forum/viewtopic.php?t=697

http://lasikflap.com/forum/viewtopic.php?t=636

http://lasikflap.com/forum/viewtopic.php?t=1667

_________________
Bill

"What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?" Dr. Sarah Smith


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