Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
9/9/2013

Post-operative quality-of-life studies on military personnel who have undergone LASIK eye surgeries have been delayed indefinitely due to personnel “deployments and the focus of all military staff on the war efforts,” an FDA spokeswoman tells FDA Webview. The study, known as Patient-Reported Outcomes with LASIK (PROWL-1) and commissioned by FDA under a Department of Defense contract to be conducted at the Naval Medical Center San Diego, was announced in 2009 but mysteriously kept under wraps for a year. In October 2010, FDA issued an update estimating that enrollment would begin with three months and completion by the end of 2012.

FDA Webview was told that enrollments for the final, non-military phase of the studies, known as PROWL-2, will be completed in December 2013.

Although activists for injured LASIK patients have shown skepticism about the objectivity of the studies, since Navy ophthalmology surgeons have publicly expressed enthusiasm for the controversial procedure, it is expected that they will shed light on complaints that it leads to a serious adverse reaction rate far higher than the maximum 1% on which FDA approval was based.

Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.
7/25/2013

Thirty-one months after it back-burnered a former CDRH [FDA’s Center for Devices and Radiological Health] branch chief’s petition seeking withdrawal of the LASIK indication for ophthalmic lasers based on unacceptably high permanent injury rates, CDRH has been sent a new retrospective study indicating that 21% of patients with serious corneal pain had received laser surgery on their eyes. The 6/14 study, from Harvard Medical School assistant clinical professor and Boston EyePain Foundation founder Perry Rosenthal, found 21 out of 100 consecutive patients diagnosed with centralized corneal pain had previously undergone laser keratorefractive surgery.

In his moribund petition, former CDRH branch chief for diagnostic and surgical devices Morris Waxler complained about a LASIK industry-promoted injury rate of less than 1% on which his review team had based its approval of the devices, compared with his subsequent assessment of an injury rate in excess of 20%. Waxler alleged that “Manufacturers and their collaborators withheld more than 10% of the adverse event data from 13 of the 25 studies, more than 20% from 12 studies, and more than 40% from seven studies.”

He said manufacturers pressured FDA to not include halos, glare, night vision problems, and dry eyes as adverse events in order for their lasers to meet FDA’s requirement of a less-than-1% adverse event rate. After approval, FDA decided these “symptoms” should be reportable events.

The new study by Rosenthal, which was rejected by two ophthalmic professional journals* heavily supported by the LASIK industry, carries the adverse event rate far beyond the six-month post-operative followup point in most of Waxler’s data, extending out as far as 15 years post-op. Rosenthal found eight patients who had experienced symptoms immediately after surgery, three whose symptoms were delayed between three and 28 days, two who experience symptoms between one and six weeks post-op, and eight whose symptoms began between one and 15 years post-op.

Rosenthal’s study describes the symptoms observed as chronic centralized neuropathic corneal pain. It says the recognition that this “can be a complication of laser keratorefractive surgery is the first step to developing mechanism-based treatments for this overlooked, crippling and currently intractable neurological complication.”

Rosenthal acknowledges in the study that the 21 subjects described differed from those who experienced “typical” post-LASIK dry eye-like pain in that they reported “higher intensity descriptors such as burning, aching, pressure, stabbing and in many of these patients, the presence of otherwise unexplainable photosensitivity (photoallodnia).”

He dismisses what he calls “anecdotal observations” that suggest centralized corneal neuropathic pain is rare. “This begs the question of why some people are susceptible to this complication,” he writes. “Vulnerability to neuropathic pain is believed to be influenced by certain genetic and epigenetic factors and efforts to develop useful predictive tests continue, including measurements of an individual’s endogenous sensitivity to pain.”

Rosenthal recommends screening of LASIK candidates for family history of autoimmune diseases which are known to be associated with a higher incidence of peripheral neuropathies. “Reports that delayed treatment of post-operative pain has a deleterious effect on pain outcomes suggest that [post LASIK] pain should be treated aggressively and perhaps even preemptively,” Rosenthal says in his study report. “In this context, early interventions that accelerate corneal epithelial and nerve healing and suppress inflammation may also be helpful in avoiding the transition to centralized corneal neuropathic pain. Because of the devastating nature of this complication the search for effective topical analgesics capable of being used safely prior to and for an extended period of time after surgery is, in my opinion, a high priority.”

* Elsevier’s [Ophthalmology:] Journal of the American Academy of Ophthalmology and The Journal of Cataract and Refractive Surgery

4/20/2013

A new website, LasikScandal.com, reveals risks and adverse effects of LASIK eye surgery, and exposes LASIK industry corruption. LasikNewswire’s editor interviewed the new site’s Director & Medical Researcher, Justice.

LNW: Good evening, Justice, and thanks for giving us this interview. Tell us about yourself. How did you become interested in LASIK?

Justice: I had a bad outcome from LASIK several years ago. I suffer from chronic dry eyes and distorted night vision — starbursts, halos, double vision… It turned my life upside down. I needed to understand why, what went wrong, and if it could be corrected. So that’s why I began my research.

LNW: And what did you find out? I mean, what went wrong?

Justice: Well, nothing went wrong according to my surgeon. But really, everything went wrong. When you do surgery on perfectly healthy, normal tissue… When you create a flap one-third the thickness of the cornea, and then vaporise more of the cornea with a laser, the cornea never recovers fully. Researchers have found permanent pathologic changes in all post-LASIK corneas studied.

LNW: You said you have night vision problems. Do you have large pupils?

Justice: Yes, and of course, that’s the problem.

LNW: Where did your research lead, as far as finding a solution for your vision problems?

Justice: Well, I consulted several leading surgeons. They proposed a retreatment. One surgeon actually suggested corneal transplant, bilateral. By that point I knew the risks associated with another surgery. Not only that, but also, the data seemed unconvincing that a retreatment would be effective. I decided to try rigid contact lenses, but my expectations were low because I had not been able to tolerate hard lenses before LASIK, and now, with my eyes much drier after LASIK, I knew they would be difficult to tolerate, and that was the case.

LNW: How has LASIK-induced dry eyes affected you?

Justice: I’m glad you asked that question because, unless you’ve experienced first-hand the pain and burning and all the rest that goes with it, people seem to think that dry eyes is just a minor issue that is easily managed with eye drops. But that’s definitely not the case. It has a huge impact on my life. I have to plan my activities around it. I always carry eye drops and goggles wherever I go. My eyelids stick to my eyes. It’s scary and painful. I instill eyedrops several times throughout the night. My optometrist once told me, “Your corneas are pretty beat up”. Beat up from the dryness and trying to wear lenses.

LNW: Let me get this straight. You need to wear hard lenses because your vision is impaired by LASIK, but LASIK caused you to have extremely dry eyes which makes it difficult, or impossible, to tolerate lenses?

Justice: (laughs) Yeah, crazy, right?

LNW: And tell our readers how LASIK causes dry eyes.

Justice: Mainly because corneal nerves are damaged. A normal cornea is highly innervated. It needs to be to protect your eyes, to let you know if your eyes are dry, to blink, or if you get sand in your eyes, to make tears to wash the sand out. But LASIK cuts the nerves and destroys nerves in the cornea. The feed-back loop is disrupted. The eyes are dry but there’s no information transmitted from the corneal surface telling the brain to send the message back to the lacrimal glands to produce tears.

LNW: What did your LASIK surgeon tell you, or warn you, about dry eyes before LASIK?

Justice: He never mentioned it. I still have a glossy brochure from his office which said that you’ll need to use eye drops for two weeks after LASIK.

LNW: Just two weeks?

Justice: That’s what it says. Two weeks.

LNW: The FDA website warns that dry eyes after LASIK can be permanent, so…

Justice: Right, I was not informed. You think you can trust doctors. It’s just not in our DNA to believe a doctor would hurt you.

LNW: I’m sorry. Is there anything else you would like to say about your experience?

Justice: Well, it’s not just the dry eyes and the bad night vision. It’s the betrayal of trust and the denial. It’s a bitter pill to swallow. It takes its toll. And then the cost. It’s crazy what you spend trying to manage LASIK complications. Thousands of dollars, year after year. And the ripple effect on all aspects of your life, and even your family’s lives. It’s devastating. And you feel as if you have no future. It’s not the life you expected. But you learn to keep going, you have to.

LNW: You’re wearing glasses. What is your vision like with glasses?

Justice: Yes, I started regressing right away, and my vision has been unstable ever since. In the daylight with glasses I see pretty well. I can function normally in bright light. But in dim light, or night-time, forget it. I dread the short days of winter. I don’t drive at night. I also have induced floaters, which bother me in bright light, I almost forgot. (laughs).

LNW: Floaters, dry eyes, bad night vision, regression? Anything else?

Justice: Induced astigmatism. And DLK.

LNW: Tell our readers. What is DLK?

Justice: Diffuse lamellar keratitis. Inflammation of the cornea. I had it in one eye and it left mild scarring.

LNW: Do you believe you were a bad candidate?

Justice: Yes, I do. I was becoming intolerant to my soft contact lenses, which indicates dry eyes, so that should be a contraindication. And I have large pupils, and that’s a definite contraindication, regardless what you might hear, it is a contraindication, period. But even if you’re a so-called ‘perfect candidate’, LASIK always leads to dry eyes, at least for a period of time, and virtually always reduces night vision. It’s a matter of severity. If your eyes are dry before, they’re going to be a lot drier. If you have large pupils, you’re going to have worse night vision than someone who has smaller pupils with the same refractive error. I see LASIK ads talking about newer technology and better night vision. No technology can treat a patient, appropriately, with very large pupils without taking off too much tissue. You only have so much cornea.

LNW: Yeah, if you remove too much corneal tissue, you place the patient at risk of corneal ectasia.

Justice: Right. That’s the complication that LASIK surgeons most want to keep quiet.

LNW: Justice, thanks for telling us your story. Before we wrap this up, let’s talk about LasikScandal.com. It’s a great looking site.

Justice: Thanks, but I’m not the web designer. Jeff and Bob deserve the credit.

LNW: You write content for the site?

Justice: I wrote some of the content, yes.

LNW: Well, it’s very compelling, well researched. I understand you’re building a patient registry.

Justice: Yes, now that we’ve got a site up, we’re going to be focusing on the patient registry and the forum.

LNW: Justice, thank you again. Best of luck with the new site.

Justice: Thank you.

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

• 20/20 Institute Indianapolis LASIK, of Indianapolis
• Scott Hyver Visioncare Inc., of Daly City, Calif.
• Rand Eye Institute, of Deerfield Beach, Fla.
• Eye Center of Texas, of Bellaire, Texas
• Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to 20/20 Institute Indianapolis LASIK addressed to Mark S. Danzo, O.D.

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

• 20/20 Institute Indianapolis LASIK, of Indianapolis
• Scott Hyver Visioncare Inc., of Daly City, Calif.
• Rand Eye Institute, of Deerfield Beach, Fla.
• Eye Center of Texas, of Bellaire, Texas
• Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Scott Hyver Visioncare

From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

• 20/20 Institute Indianapolis LASIK, of Indianapolis
• Scott Hyver Visioncare Inc., of Daly City, Calif.
• Rand Eye Institute, of Deerfield Beach, Fla.
• Eye Center of Texas, of Bellaire, Texas
• Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Rand Eye Institute addressed to William J. Rand, M.D.

January 14, 2013
From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

• 20/20 Institute Indianapolis LASIK, of Indianapolis
• Scott Hyver Visioncare Inc., of Daly City, Calif.
• Rand Eye Institute, of Deerfield Beach, Fla.
• Eye Center of Texas, of Bellaire, Texas
• Woolfson Eye Institute, of Atlanta

“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Eye Center of Texas addressed to Edward C. Wade, M.D.

January 14, 2013
From a 12/18/2012 FDA press release:

The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events.

The five providers that received FDA Warning Letters are:

20/20 Institute Indianapolis LASIK, of Indianapolis
Scott Hyver Visioncare Inc., of Daly City, Calif.
Rand Eye Institute, of Deerfield Beach, Fla.
Eye Center of Texas, of Bellaire, Texas
Woolfson Eye Institute, of Atlanta
“Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”

Continue reading press release

Read warning letter to Woolfson Eye Institute addressed to Jonathan Woolfson, M.D.