LASIK

FDA’s Proposed LASIK Warning May Leave Patients Less Informed

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The agency’s recommendations should balance risk with benefit

A photo of ophthalmologists performing LASIK surgery on a female client.

LASIK surgery has been studied continuously since the FDA approved the procedure nearly a quarter century ago. These studies include careful documentation of the success rates in improving vision without the need for glasses, as well as the risks for complications. This information has long been included in the labelling for the devices used in LASIK. Yet, the FDA recently decided to propose new documents revising the description of risks and benefits.

We, at the American Academy of Ophthalmology (AAO), share the goals of the FDA: to protect patient safety, and to help patients make an informed choice, meaning a choice based on complete information that includes not just risks and benefits, but a good sense of the likelihood of these outcomes. However, the FDA has produced a statementopens in a new tab or window that focuses so heavily on risks that it makes it difficult for patients to accurately assess the appropriateness of LASIK for their situation.

The efficacy of LASIK is well supported by numerous studies. A reviewopens in a new tab or window of nearly 100 research articles representing nearly 70,000 eyes has reported that more than 90% of eyes undergoing LASIK had 20/20 or better vision without glasses, and more than 99% driving vision of 20/40 or better. The U.S. military has also generated a great deal of useful information and has trusted refractive surgery to improve the vision of active servicemen and women for many years, becoming one of the largest providers of refractive surgery in the country. Rigorous studies performed by the military have described the safety and effectivenessopens in a new tab or window of LASIK in terms of night visionopens in a new tab or window, night drivingopens in a new tab or window, flight performanceopens in a new tab or window, and firing performanceopens in a new tab or window.

The FDA’s own well-conducted PROWL studyopens in a new tab or window on outcomes following LASIK found high rates of patient reported satisfaction: While most participants were satisfied, the rates of dissatisfaction with vision ranged from 1% to 4%, and the rates of dissatisfaction with surgery ranged from 1% to 2%.

As successful as refractive surgery is, it is not for everyone. Some patients have eye conditions or anatomy that are not well suited to laser treatment. Even when appropriate, no surgical intervention can be risk-free. The discussion that educates patients on whether surgery is right for them, along with the benefits and risks of LASIK based upon their unique profile and needs is a critical element of the decision-making process. AAO’s Code of Ethics dictates that it is the physician performing the procedure who is responsible for educating the patient and obtaining meaningful informed consent.

The topics covered in the guidance document — the risks for problems such as double vision, dry eyes, difficulty driving at night, and, in rare cases, persistent eye pain — are all important for the informed consent process, but they must be presented with sufficient depth and nuance for the patient to better understand what these data mean for them. We believe that effective informed consent is not merely a listing of potential poor outcomes that one must know about, but a process of shared information and decision-making that happens interactively between the physician and the patient, where both come to thoroughly understand the patient’s situation, goals, and motivations.

Beyond the ethical imperative, AAO believes that an informed patient, whether they choose to undergo surgery or not, is a more satisfied patient. This is why we have generated extensive educational resources for both ophthalmologists and their patients, including a patient guide to refractive surgeryopens in a new tab or window, which we produced in partnership with the FDA. AAO-affiliated Ophthalmic Mutual Insurance Company provides a comprehensive informed consent form in both English and Spanish that is widely used by physicians and their patients. Additionally, AAO’s EyeSmart program offers evidence-based and commercially unbiased information about eye health, including vision correction surgeriesopens in a new tab or window such as LASIK. And we offer guidelinesopens in a new tab or window to assist ophthalmology practices in providing ethical, informative advertising for refractive surgery.

Beyond the issues of balance, nuance, and personalization, we are also concerned that the proposed update to patient guidance on LASIK surgery provides information that does not reflect the most current clinical evidence. For example, the suggested guidance lists pupil size as a risk factor for complications. The issue of pupil size has been studied extensively over the years. Data from published studiesopens in a new tab or window of modern lasers fail to demonstrate a relationship between pupil size and the quality of postoperative vision. And yet, FDA lists pupil size as a risk factor for poor vision after LASIK surgery.

The FDA’s proposal is not final. More than 600 individuals and professional groups have weighed in with comments since the draft of the guidance was made public in July, and the agency is now reviewing the input while preparing the final documents. Many comments reflect these concerns, and we hope that the FDA will consider them seriously.

AAO has a long and productive relationship with the FDA. We look forward to continuing our collaboration to ensure that our common goal is met: to educate the public about LASIK and its outcomes with an evidence-based and balanced approach.

FDA May Issue Warnings About LASIK Surgery

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The FDA is reviewing comments on a draft policy that could alter the way Americans see LASIK surgery to improve their vision.

The FDA proposal pushes for warnings about double vision, dry eyes, ongoing pain, and other issues. It even says people might still need eyeglasses after the surgery.

About 500,000 adults opt for the procedure each year. Many people view the procedure as safe and commonplace, The New York Times reported, and that could change if the FDA adopts the advisories.

LASIK, which stands for laser in-situ keratomileusis, is a popular surgery that can correct vision in people who are nearsighted or farsighted or who have astigmatism.

It’s one of many vision correction surgeries that work by reshaping your cornea, the clear front part of the eye, so that light focuses on the retina in the back of your eye.

It takes about 15 minutes per eye and has been performed for about 25 years. It can cost thousands of dollars, and most insurance plans don’t cover it.

Most people report satisfaction with LASIK results.

The Times reported that many ophthalmologists insist it is safe with only rare long-term complications.

“All we’re asking for is balance,” said Vance Thompson, MD, incoming vice president of the American Society of Cataract and Refractive Surgery. “This document mainly emphasizes the dangers and complications of Lasik, with no mention of the advantages, and the tone is negative enough that it will scare patients.”

The FDA draft says some patients become depressed, even considering suicide. Chronic conditions such as diabetes and some prescriptions can put people at risk.

Warnings would benefit consumers, said Paula Cofer, a Florida woman who claims LASIK ruined her vision and caused chronic pain. “Right now, even if patients do research on the internet and see warnings, they think it’s just one or two unhappy people. Now they see it’s the F.D.A. saying this.”

Noninvasive technique to correct vision

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Engineers have developed a noninvasive approach to permanently correct vision that shows great promise in preclinical models. The method uses a femtosecond oscillator for selective and localized alteration of the biochemical and biomechanical properties of corneal tissue. The technique, which changes the tissue’s macroscopic geometry, is non-surgical and has fewer side effects and limitations than those seen in refractive surgeries. The study could lead to treatment for myopia, hyperopia, astigmatism, and irregular astigmatism.
Corneal topography before and after the treatment, paired with virtual vision that simulates effects of induced refractive power change.
 

Nearsightedness, or myopia, is an increasing problem around the world. There are now twice as many people in the US and Europe with this condition as there were 50 years ago. In East Asia, 70 to 90 percent of teenagers and young adults are nearsighted. By some estimates, about 2.5 billion of people across the globe may be affected by myopia by 2020.

Eye glasses and contact lenses are simple solutions; a more permanent one is corneal refractive surgery. But, while vision correction surgery has a relatively high success rate, it is an invasive procedure, subject to post-surgical complications, and in rare cases permanent vision loss. In addition, laser-assisted vision correction surgeries such as laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) still use ablative technology, which can thin and in some cases weaken the cornea.

Columbia Engineering researcher Sinisa Vukelic has developed a new non-invasive approach to permanently correct vision that shows great promise in preclinical models. His method uses a femtosecond oscillator, an ultrafast laser that delivers pulses of very low energy at high repetition rate, for selective and localized alteration of the biochemical and biomechanical properties of corneal tissue. The technique, which changes the tissue’s macroscopic geometry, is non-surgical and has fewer side effects and limitations than those seen in refractive surgeries. For instance, patients with thin corneas, dry eyes, and other abnormalities cannot undergo refractive surgery. The study, which could lead to treatment for myopia, hyperopia, astigmatism, and irregular astigmatism, was published May 14 in Nature Photonics.

“We think our study is the first to use this laser output regimen for noninvasive change of corneal curvature or treatment of other clinical problems,” says Vukelic, who is a lecturer in discipline in the department of mechanical engineering. His method uses a femtosecond oscillator to alter biochemical and biomechanical properties of collagenous tissue without causing cellular damage and tissue disruption. The technique allows for enough power to induce a low-density plasma within the set focal volume but does not convey enough energy to cause damage to the tissue within the treatment region.

“We’ve seen low-density plasma in multi-photo imaging where it’s been considered an undesired side-effect,” Vukelic says. “We were able to transform this side-effect into a viable treatment for enhancing the mechanical properties of collagenous tissues.”

The critical component to Vukelic’s approach is that the induction of low-density plasma causes ionization of water molecules within the cornea. This ionization creates a reactive oxygen species, (a type of unstable molecule that contains oxygen and that easily reacts with other molecules in a cell), which in turn interacts with the collagen fibrils to form chemical bonds, or crosslinks. The selective introduction of these crosslinks induces changes in the mechanical properties of the treated corneal tissue.

When his technique is applied to corneal tissue, the crosslinking alters the collagen properties in the treated regions, and this ultimately results in changes in the overall macrostructure of the cornea. The treatment ionizes the target molecules within the cornea while avoiding optical breakdown of the corneal tissue. Because the process is photochemical, it does not disrupt tissue and the induced changes remain stable.

“If we carefully tailor these changes, we can adjust the corneal curvature and thus change the refractive power of the eye,” says Vukelic. “This is a fundamental departure from the mainstream ultrafast laser treatment that is currently applied in both research and clinical settings and relies on the optical breakdown of the target materials and subsequent cavitation bubble formation.”

“Refractive surgery has been around for many years, and although it is a mature technology, the field has been searching for a viable, less invasive alternative for a long time,” says Leejee H. Suh, Miranda Wong Tang Associate Professor of Ophthalmology at the Columbia University Medical Center, who was not involved with the study. “Vukelic’s next-generation modality shows great promise. This could be a major advance in treating a much larger global population and address the myopia pandemic.”

Vukelic’s group is currently building a clinical prototype and plans to start clinical trials by the end of the year. He is also looking to develop a way to predict corneal behavior as a function of laser irradiation, how the cornea might deform if a small circle or an ellipse, for example, were treated. If researchers know how the cornea will behave, they will be able to personalize the treatment — they could scan a patient’s cornea and then use Vukelic’s algorithm to make patient-specific changes to improve his/her vision.

“What’s especially exciting is that our technique is not limited to ocular media — it can be used on other collagen-rich tissues,” Vukelic adds. “We’ve also been working with Professor Gerard Ateshian’s lab to treat early osteoarthritis, and the preliminary results are very, very encouraging. We think our non-invasive approach has the potential to open avenues to treat or repair collagenous tissue without causing tissue damage.”

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Materials provided by Columbia University School of Engineering and Applied Science.

Many LASIK patients may wind up with glare, halos or other visual symptoms, study suggests

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LASIK isn’t always as awesome as we might think.

Millions of Americans each year undergo LASIK surgery to correct their vision. Given how common the procedure has become and how ubiquitous the ads are on radio and TV, you might be tempted to treat the decision to get the treatment pretty casually or think of it as purely a financial decision. A team of researchers from the Food and Drug Administration, the National Eye Institute and the Department of Defense would like to make sure you weigh the potential risks to your eyes more seriously.

In 2009, as LASIK was becoming a household word, the government scientists launched a major study to investigate reports of adverse impacts from the procedure. At the time, there were a lot of anecdotes flying around but little scientific information about patient outcomes. The results, published in October 2014, showed that some patients developed problems that adversely affected their day-to-day lives, such as difficulty driving at night or in sunshine. But it was such a small number — less than 1 percent — of the patients in the study that it was difficult to draw any strong conclusions from that data.

On Wednesday, the group released a follow-up report in JAMA Ophthalmology that provides more sobering information. The study suggests that the percentage of people who undergo LASIK and wind up with new visual symptoms — such as double images, glare, halos or starbursts — may be much higher. The data was based on a questionnaire that looked at patient satisfaction with their vision and at visual and dry-eye symptoms following surgery.

First, the good news. More than 95 percent of participants said they were satisfied with the improvements to their vision. In addition, the prevalence of dry-eye symptoms also decreased after surgery. The bad news is that a “substantial” percentage of the study participants said they had other, new symptoms following the procedure.

The study analyzed outcomes for two groups of LASIK patients. In the first group, which included 262 Navy personnel with an average age of 29.1, it was 43 percent reporting new symptoms. And in the second, consisting of 312 civilians at five practice and academic centers and with a median age of 31.5, it was 46 percent. In addition, about 28 percent of patients who had never had dry-eye symptoms before developed mild, moderate or severe symptoms three months after the procedure.

“To our knowledge, our study is one of the few that have reported the development of new visual symptoms,” Malvina Eydelman of the U.S. Food and Drug Administration and colleagues wrote. “While the overall prevalence of visual symptoms decreased, a large percentage of participants with no symptoms preoperatively reported new visual symptoms postoperatively.”

One interesting component of this study was that the survey showed that the percentage of people with symptoms may be much higher than what has been previously reported in studies involving direct interviews with health-care professionals. The authors of the new study note that the reluctance of patients to tell their doctors about “negative” events has been well documented.

The researchers cautioned that the study may not generalize to the LASIK population as a whole because of its small sample size and short follow-period, which was typically three months. However, they emphasized that “although the magnitude of the development of symptoms is uncertain, patients undergoing LASIK surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery prior to undergoing this elective procedure.”

New laser surgery technique can turn your brown eyes blue.

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New laser surgery technique can turn your brown eyes blue

Of all the features we notice about a person upon meeting them, their eyes are often the first connection we make. But some people just aren’t satisfied with the color of their peepers, wishing their dark corneas away in favor of a pleasant shade of blue. Those unhappy with brown eyes may find just what they’re looking for: Laguna Beach doctor Gregg Homer has developed a new procedure that can actually convert brown-colored eyes to blue in just a matter of weeks.

The operation itself is fairly straight forward: Using a laser tuned to a special frequency, the doctoractually alters the cells that produce the brown coloration in the eye. After a few weeks, the darker color begins to fade, revealing the blue pigment underneath. As the doctor explains it, the procedure only works for brown-eyed individuals, as they already have a bluish coloration hiding underneath.

According to Homer, the procedure takes just 20 seconds to complete. And because of the large number of people wishing they were born with baby blues, he has already been contacted by thousands of potential clients. Homer and his company, Stroma Medical, have been working on the technology for over a decade, and say it will be available on a consumer basis within three years.

He estimates the procedures will cost about $5,000 each, and as the brown coloration doesn’t appear to regenerate, your eyes should stay blue for the rest of your days. Unfortunately, that almost means it’s completely irreversible, so if you end up regretting a hasty decision to switch, you’ll never be brown-eyed again.

Not surprisingly, the practice has come under scrutiny by some who believe the color of our eyes is somehow more sacred than other parts of the human body — like the bits that plastic surgeons alter every day. There’s also the risk that long-term damage may result from the procedure, and without longitudinal research, Homer can’t guarantee that problems won’t arise down the road. Still, with would-be patients lining up by the thousands, it’s clear that some people believe the risk is worth the reward.mw-630-flickr-look-into-my-eyes-630w

 

Obama awards science medal to Indian-American inventor.

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http://www.dailypioneer.com/home/online-channel/396-india-abroad/125247-obama-awards-science-medal-to-indian-american-inventor.html