Exposing the LASIK Scam

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PostPosted: Tue May 30, 2006 2:30 pm 
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http://www.eyeworld.org/article.php?sid=2824

Brian Boxer Wachler, M.D. on pupil size:

Halos were associated with spherical aberration for the scotopic pupil size.
?I find this as well,? Dr. Boxer Wachler said. ?The reason is that if you look at the very center of the topography and look towards the periphery, the corneal power gets steeper. If the steeper power transition occurs relatively close to the center of topography ? as in higher myopes, and/or smaller laser optical zones ? this causes more spherical aberration.?
Glare also was significantly correlated with spherical aberration and total aberration. Starburst was associated with spherical aberration and total aberration for the scotopic pupil size.



http://www.webmd.com/content/article/22/1728_56108.htm

If you choose LASIK, Boxer Wachler suggests asking the surgeon if the procedure is safe with your pupil size, because people with large pupils are at greater risk for decreased night vision and halos (the glare that appears over certain objects).

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PostPosted: Tue May 30, 2006 2:44 pm 
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Dan Durrie, MD on pupil size:

http://www.durrievision.com/index.cfm/l ... ion/lvcfaq

"Another possible cause of nighttime side-effects is pupil size. At night, the pupil expands to let in more light. Light coming through the peripheral cornea may be out of focus if the pupil opens beyond the laser treatment area. This is why some patients are not good candidates for LASIK if they have very large pupils. "

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Barrie Soloway, MD on pupil size:

http://www.ihateglasses.com/html/large_ ... ents_.html

"Most patients with large pupil sizes who receive laser surgery will experience varying degrees of what's referred to in the medical field as GASH (Glare, Arching, Star bursts or Haloes) during night-driving. "

http://www.ihateglasses.com/html/ocular ... _1_01.html

"This study proved that the main reason for poor post-LASIK night vision was in fact the diameter of the laser beam being smaller than that of the pupil."

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Jack Holladay, MD on pupil size:


http://www.revophth.com/index.asp?page=1_54.htm

The High Cost of Inaccurate Pupillometry

"Accurate pupillometry is an essential part of the evaluation for refractive surgery. With reports of halos and glare following refractive surgery on many of the prime-time news shows, pupillometry has become one of the preoperative tests that patients expect. It is very clear from the published and anecdotal reports of nighttime glare and halos that a large pupil is the predominant factor leading to these problems."

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 Post subject: Pupil diameter correlates w/lost contrast sensitivity, HOA
PostPosted: Sat Jun 03, 2006 2:59 pm 
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http://www.osnsupersite.com/default.asp?ID=12752

OCULAR SURGERY NEWS 4/12/2006

Pupil diameter study shows correlation with aberrations, contrast sensitivity after LASIK

In eyes with larger pupils who were treated with LASIK, spherical-like aberrations affect contrast sensitivity, whereas in eyes with smaller pupils coma-like aberrations are more likely to affect visual performance.

?In eyes with larger photopic pupil diameter, increases in spherical-like aberration dominantly affect contrast sensitivity, whereas in eyes with smaller pupil size, changes in coma-like aberration exert greater influence on visual performance,? said Tetsuro Oshika, MD.

Out of the 215 eyes tested in 117 patients, 105 of them had a photopic pupil diameter of 4 mm or larger while 110 were smaller than 4 mm. In the former group, there were no significant effects in third-order coma-like aberrations and, in the latter group, there were no significant effects in fourth-order spherical-like aberrations.

Conversely, the larger pupil group showed significant correlation between changes in the area under the log contrast sensitivity function (AULCSF) and a 10% change in low-contrast visual acuity. The smaller pupil group produced significant correlation between the changes in coma-like aberrations and the changes in AULCSF and a 10% change in low-contrast visual acuity.

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PostPosted: Fri Jun 23, 2006 11:36 pm 
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http://www.revophth.com/index.asp?page=1_953.htm

Review of Ophthalmology
Vol. No: 13:06Issue: 6/7/2006

How to Get the Most Out of LASIK

Samir Melki, MD, PhD , Boston

Excerpt:

"The risk factors I personally look for when assessing the risk of postop halos are large pupils, high prescriptions (above -6 D) and astigmatism above 2 D."

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http://www.revophth.com/index.asp?page=1_661.htm

Review of Ophthalmology


Quote:
"Dr. Holladay says correcting this problem is important for two reasons. First, making the cornea oblate increases spherical aberration. "The surface of the cornea in front of the scotopic pupil must be prolate in order for the rays in the periphery not to bend too strongly, causing blurred focus," he says. "Making the cornea oblate increases the total spherical aberration of the eye, producing nighttime halos and glare complaints."

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http://www.revophth.com/index.asp?page=1_972.htm

Excerpt:


Based on his experience, Dr. Salz offers the following strategies for creating happier patients and reducing the risk of lawsuits:

? Don?t tell patients pupil size doesn?t matter. Dr. Salz notes that two recent studies found that large-pupil patients had the same incidence of night glare, halos and night vision complaints as patients with smaller pu?pils. Because of these studies, he says, some surgeons are telling their patients that pupil size is not a risk factor for night vision problems. ?These studies were well done, by reliable in?vestigators,? he says, ?but they were done with specific lasers, one of them using an algorithm not available in the United States. You can?t assume that your laser will produce the same re?sults. There are other studies that give us good reason to see pupil size as a risk factor?not to mention the recent $3 million award.?

Dr. Salz notes that numerous studies have shown that higher-order ab?errations increase with pupil size. ?For example,? he says, ?consider the wavefront analysis of one of my preop pa?tients, who had the largest scotopic pu?pils I?ve encountered to date?at times over 9 mm. When her left pupil diameter was 8 mm, her spherical ab?er?ration was .21 and her coma was .52. When she was dilated to 9.7 mm?close to her natural scotopic pupil size
?her spherical aberration more than doubled to .43, and coma reached 1.36.

?You also have to consider that even custom LASIK will probably make these numbers worse,? he adds. ?With this patient we did extensive informed consent, showing her the relationship between pupil size and higher-order ab?errations, and explaining that the surgery might make the aberrations worse. Because she was highly motivated, she chose to proceed with the first eye. Postop, with the pupil at 8.6, her spherical aberration rose to 2.2?10 times her preop 8-mm number.

?The bottom line is if you tell a patient he?s not at risk because of his pupil size, regardless of your justification, he may later go to someone else,? he says. ?If that doctor makes his pupil smaller and his symptoms go away, how can you argue that the pupil was not important? In addition, the pa?tient brochures for custom surgery from Visx and Alcon both warn that patients are at risk of vision problems if they have larger-than-normal pupils. Even the FDA website contains a similar warning. So not telling the pa?tient that he?s at risk unquestionably puts you at risk.?

Dan Tran, MD, medical director for Coastal Vision Laser Eye Center in Newport Beach, Calif., agrees. ?Pupil size does matter, for two reasons,? he says. ?First, if the pupil is large and the treatment area is large, you?re not going to end up with a prolate cornea. There?s no way you can maintain a prolate shape under those conditions, even with wavefront. That means you?re going to increase spherical ab?erration. And the greater the correction, the more significant the problem.

?Second,? he continues, ?the treatment must be perfectly centered, taking into account not only the pupil, but also the visual axis. A slight decentration will cause problems if the pupil is large, and the larger the pupil size, the more likely it is that you?ll get into trouble.?

? Do one eye and see how the pa?tient reacts. ?I do one eye at a time in everybody,? says Dr. Salz, ?but particularly in a large pupil patient. That way I don?t do the second eye until I?m sure that they?re satisfied with their night vision.?

? Pretest with Alphagan. If a patient has large pupils, Dr. Salz suggests making sure that eye drops will be an option for countering dilation at night. ?Let the patient know that he might need to use the drops for the rest of his life to minimize night vision problems,? he says.

? For large pupils, do preop wavefront analysis. If the pupil is bigger than 6.5 mm, do a wavefront study and see how high the preop wavefronts scores are. If a patient has a relatively low level of aberrations, he?ll probably be fine.

? If possible, perform custom LASIK. ?Conventional surgery tends to double preop higher-order aberrations,? observes Dr. Salz. ?If the pa?tient starts with .5 RMS and you do conventional LASIK, you may double that to 1.0, and the pa?tient will probably have a lot of trouble.

?In contrast,? he continues, ?custom surgery doesn?t generally increase these aberrations as much as conventional LASIK.? Dr. Salz says this has been borne out by his clinical experience. ?Since we?ve begun performing wavefront-based treatments, I haven?t had a single patient?even the patient with the 9-mm pupil?choose not to have the second eye done. That wasn?t true when I was doing conventional surgery. Some of those patients have never done their second eye because they were so freaked out by the quality of their night vision.?

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PostPosted: Thu Sep 07, 2006 9:04 pm 
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EyeWorld
Sept. 2005

Pupil size, accommodation among hot summer refractive topics

by Matt Young EyeWorld Staff Writer

EyeWorld reporting live from the 2005 Summer Refractive meeting.

Pupil size matters in refractive surgery

Quote:
There is a definite relationship between pupil size and night vision problems, said William Trattler, M.D., the Center for Excellence in Eye Care, Miami. Dr. Trattler has used an objective measuring device?the Larson Glarometer?to quantify the size of the starburst that patients treated with an excimer laser see. The Larson Glarometer does not have a corporate manufacturer. Regardless of whether they have received wavefront or conventional treatment, patients with larger scotopic pupil sizes saw a larger starburst radius.


Read entire article at: http://www.eyeworld.org/article.php?sid=2673

BE's comment: This is exactly the message we are trying to get out. Sure, some patients with normal pupil sizes have night vision disturbances, but the larger the pupil, the greater the severity of NVD. (The greater the mismatch between effective optical zone and pupil size, the greater the aberrations.) That's a major flaw in Schallhorn's studies -- he doesn't measure the severity of the visual disturbances.

Another way to measure objectively is with aberrometers that can measure at patient's scotopic pupil size, as opposed to measuring everyone at 6mm. It doesn't even make sense to do a 6.5 mm optical zone plus a blend zone, then measure everyone at 6 mm. It's what the patient actually sees that matters. A patient with a 5 mm pupil won't see what a patient with an 8 mm pupil sees.

Doctors who say pupil size doesn't matter are idiots, not experts.

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http://www.aao.org/education/focal_poin ... 3.04-2.pdf

FOCALPOINTS
American Academy of Ophthalmology

CLINICAL MODULES FOR OPHTHALMOLOGISTS

VOLUME XXII NUMBER 13 SEPTEMBER 2004 (ONLINE)

LASIK Complications

Quote:
Patient Selection Errors

A significant percentage of LASIK complications occur due to improper patient selection during the preoperative assessment. Attention should be directed toward a detailed medical and ocular history, accurate measurement of manifest and cycloplegic refraction, pupil size, corneal pachymetry, and corneal topography
.

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http://www.crstoday.com/PDF%20Articles/ ... 6_supp.pdf

"In 2006, a 45-year-old white male presented with major
night vision problems after undergoing PRK for myopia
(-8.00D) in 1997. Topography revealed a small optical zone.
The goal of the treatment was to enlarge the optical zone
and thus eliminate the patient's night vision problems."


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http://www.crstoday.com/PDF%20Articles/ ... _legal.pdf

Dr. Donnenfeld:
Quote:
When a patient becomes a surgical candidate, he should have a boilerplate informed consent. If there is anything abnormal about his eyes, whether large pupils, high myopia, high astigmatism, dry eye, etc., you have to indicate and document that you recognize the problem(s) before you operate.


Dr. Salz:
Quote:
The point is to inform patients of the common generic complications of surgery (usually adequately covered by the written informed consent) and then also to discuss specific risk factors such as large scotopic pupils, borderline abnormal topography, or dry eye that might potentially increase their risk of an unfavorable outcome. This discussion of unique risk factors should then be documented with a note in the record.

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PostPosted: Sat Aug 25, 2007 7:45 pm 
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Bill wrote:
From the FDA website, "When is LASIK not for me?"


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


Large pupils. Make sure this evaluation is done in a dark room. Younger patients and patients on certain medications may be 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.


That has now been changed to this:

Quote:
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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Cataract & Refractive Surgery Today

Wavefront?s Effect on the Future of LASIK

http://www.crstodayarchive.com/03_archi ... 01_06.html

Quote:
Scott MacRae, MD, Professor of Opthalmology and Visual Sciences from the Department of Ophthalmology, University of Rochester Medical Center, Rochester, NY, adds, ?It is critical to know the pupil size in the evaluation of higher-order aberrations. The larger the pupil size, the greater the amount of higher-order aberrations.?

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http://www.revophth.com/index.asp?page=1_13141.htm

Review of Ophthalmology
Vol. No: 13:12Issue: 12/1/2006

More on the Challenges Of Pupil Size & LASIK

James J. Salz, MD
Los Angeles


Excerpt:

Quote:
This raises the philosophical question: Should we as refractive surgeons, recommending an elective procedure to reduce the need for glasses, be too cautious or less cautious? Dr. Shapiro evidently feels we can be less cautious in this regard and uses his reading of the literature to support his position.

He talks about the large, excellent studies of Schallhorn and Pop. Let?s take a close look at the ?large? Schallhorn study. The article by Schallhorn1 in 2003 on 100 patients with 6-mm ablation zones with refractive errors from -2.88 to -9.25 D found that patients with large mesopic pupils did have more quality of vision issues at one month, but not at six months. Of the 100 eyes studied, only two were measured as greater than 7 mm under mesopic conditions, no doubt an underestimate of the true number of patients with scotopic pupils larger than 7 mm. Why do I say this? The pupils were measured under low light (<5 lux) with the Colvard device.

An article by Netto defines scotopic measurements using the Procyon pupillometer as being performed at 0.04 lux and mesopic high at 4 lux.2 That group studied 192 eyes and found that the mean scotopic pupil size was about 6.5 mm; the mean low mesopic pupil size was about 5.6 mm; and the mean high mesopic was about 4.0 mm. A study by Twa compared infrared video and digital photography to the Colvard at three different lux settings.3 On average the infrared or digital measurements at <0.63 lux (scotopic) were about 0.5-mm larger than the measurements with the Colvard at about 5 lux. Because of the testing method, the Schallhorn study most likely underestimated true scotopic pupil size. If just one or two patients with ?small pupils? who had NVC actually had scotopic pupils greater than 6.5 mm, the analysis and conclusions would have been different. The correlation with NVC and large pupils present at one month may have also been present at six months. Since one-third of these 100 patients missed their last follow-up visit, it is uncertain whether the conclusion that the correlation with pupil size present at one month was not still true at six months. The fact that many patients with NVC complaints and large pupils ?cortically adapt? to their new vision doesn?t mean the pupils were not a factor in their original complaints.

The other recent study which failed to show a correlation with pupil size and NVC was the study by Pop.4 I would agree that this is truly a large study of 795 patients with myopia up to -9.75 D. This study found that pupil size was not predictive of NVC at any postoperative month. Attempted correction, optical zone and residual refractive error were the major risk factors for NVC. Once again the conclusion about pupil size may not be valid, as the Colvard instrument was the measuring device. Although it was stated the measurements were ?scotopic,? the testing situation in terms of lux level was not stated, so these measurements may really have been mesopic. It is also unlikely that the patients had 10 minutes of dark adaptation prior to measurement emphasized by Brown as important to obtain true scotopic pupil size.5 I believe that Dr. Pop was able to customize the ablation zone and blend zone with the Nidek laser (possibly using a larger ablation diameter and blend zone in patients with larger pupils) in a manner not available in the United States, so applying this study to current U.S. systems may not be valid.

In 1993, Roberts used an optical analysis computer program to study the effect of the optical zone with entrance pupils of 2 to 8 mm.6 The conclusion was ?Optical zone diameter must be at least as large as the entrance pupil diameter to preclude glare at the fovea, and larger than the entrance pupil to preclude parafoveal glare.? This is, of course, not always possible with high corrections and large pupils because of ablation depth constraints.

In 1996, Klonos and Pallikaris used a computer model to predict image quality after photorefractive keratectomy.7 In this article they make a statement similar to the conclusion by Roberts, which seems logical to us: ?When the ablation zone covers the entire entrance pupil, the image quality may be uniform. However, if the entrance pupil is not fully covered by the ablation zone, disturbances in night vision often are reported as starbursts and halos around bright sources of light.? In discussing their ?Excimeye? ray tracing modeling program they state: ?For example, lateral spherical aberration is the radius of the retinal blur circle relative to pupil diameter and, therefore, the wider the pupil size is, the bigger the blur circle is, resulting in a bad retinal image.?

When scotopic pupil size is greater than 7 mm, the ablation diameter cannot usually be made larger than the pupil size as recommended by Roberts and Klonos, so one would expect patients with these larger pupil sizes who have laser vision surgery to have more NVC. The fact that many of them eventually adapt to their situation, as in the Schallhorn study, should not lead us to conclude that their large scotopic pupil size is irrelevant and not a risk factor.

Wavefront measurement of higher-order aberrations gives us a new tool to objectively evaluate quality of vision issues following laser vision correction. It is an accepted fact that the measurement of higher-order aberrations is related to the aperture size of the measurement. The larger the pupil size, the greater the higher order aberration scores. Maguen et al showed that there was a statistically significant increase in total aberrations in ametropic eyes as the pupil size increased in both pre- and postoperative LASIK patients.8,9 A study by Randazzo on management of night vision disturbances showed a progressive decrease in higher-order aberrations as well as a reduction in glare and halos as the pupil diameter decreased.10

This relationship and the correlation with NVC are evident in a recent study by Chalita and Krueger on 105 post LASIK patients studied retrospectively with the Alcon LadarWave device.11 In this study, scotopic pupil size ranged from 3.0 mm to 8.5 mm: ?The larger the pupil size evaluated, the higher the ocular aberration values.? When they compared the higher order aberration for 5- and 7-mm apertures, they found that ?there is a significant difference between them (p<0.001) showing that the larger apertures have more aberrations in post-LASIK eyes.? They found a positive correlation between scotopic pupil size and starbursts (p=0.001). Glare complaints were significantly associated with spherical aberration and total aberration, and both of these were higher with increasing scotopic pupil size.

Helgeson found large pupil size measured preoperatively to correlate with an increased frequency of visual disturbances in post-LASIK patients under scotopic conditions.12

We acknowledge that the cause of NVC?s is multifactorial, and certainly amount of correction, ablation zone, residual refractive error, corneal haze and decentration all play a role. If you tell patients with large pupils that they are not at greater risk for NVCs than patients with smaller pupils, and they in fact experience significant NVCs, you will be hard-pressed to explain why their symptoms are reduced when their pupils are made smaller. This has, in fact, been our experience with large pupil patients who have NVCs. Their symptoms and their higher-order aberration scores usually diminish when their pupils are reduced. Patients with average to smaller scotopic pupils usually do not experience relief from a reduction in pupil size.

Both the Visx13 and Alcon14 patient information brochures on wavefront-based treatments mention the possible increased risk of treating patients with large pupils. Dr. Shapiro mentioned the Visx CustomVue trial several times in his article. Does he ignore the following statement from the Visx CustomVue patient information booklet (Facts you need to know about CustomVue. 2003): ?Larger pupils. Before surgery, your doctor should measure your pupil size under dim light conditions. You might have difficulty seeing in dim lighting, rain, snow, or bright glare. Whether you may have poor vision under these conditions is hard to predict because it has been studied so little.? The Alcon brochure for CustomCornea states: ?Before surgery, your doctor should measure your pupil under dim lighting conditions. If your pupils in dim light are >6.5mm, consult with your doctor about the risk that the surgery may cause negative effects on your vision, such as glare, halos, and night driving difficulty.? The FDA expects these brochures to be given to each patient.

Dr. Shapiro stated that the literature does not support that ?larger pupils are associated with greater risk of night vision problems after LASIK.? We have tried to show that there is literature that does support this correlation. I would assume by his remarks that Dr. Shapiro would have told my patient with 9-mm scotopic pupils that she was at no greater risk than if her pupils were 5 mm. This is, no doubt, what the patient from St. Louis Co., Mo., was told. He claimed that he suffered ?significant and permanent disturbances in his vision, particularly at night.? A jury there agreed, and he was given a $3 million award. Had he simply been told his pupils put him at a potentially higher risk, he most likely would not have had a case worth pursuing. Dr. Shapiro?s reading of my comments concludes that if ?we dissuade large-pupil patients from undergoing laser vision correction, we may be unfairly limiting this group of patients from enjoying its benefits.? The proper role of the surgeon is not to dissuade or encourage but present the information as fairly as possible. I certainly mention that some studies show pupil size is not predictive of NVC, while others show it may well be a factor. To simply inform these patients that their larger-than-normal pupils may potentially increase their risk of NVC, I feel, is in their best interest. The favorable experience with wavefront-based surgery and the ability to minimize symptoms with drops are helpful in putting this risk in perspective. The surgeon simply has to decide does he want to be more cautious or less cautious on this issue. I think it is considered standard of care to measure the pupil in dim light. Why bother measuring it if we don?t discuss the possible implicationswith the patient?

Finally, Dr. William Trattler has completed an interesting study objectively measuring starburst size, and this study finds a strong correlation with pupil size and a favorable influence with wavefront-based surgery. Even with wavefront-based surgery, the patients with larger pupils reported larger starbursts and the difference was statistically significant. This paper will be submitted for publication very soon.

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