At Issue: Ensuring LASIK success and minimizing complications

Earlier this summer, LASIK was the topic of a New York Times article in which patients described negative side effects and complications after the procedure, including dry eye, aberrations, blurred vision and burning.

The American Academy of Ophthalmology responded to the article, saying that while complications are possible, the risks are low.

“The risks of LASIK surgery are known in the ophthalmology community and have been studied consistently since the FDA approved the procedure 20 years ago,” AAO President Keith Carter, MD, said in the statement. “More than 300 peer-reviewed studies have shown that on average 95% of patients were satisfied with their outcome after LASIK surgery. A small number of patients have substantial and persistent symptoms after LASIK. This is why ophthalmologists continue to evaluate patient satisfaction and continue to evolve the surgery to improve patient outcomes and to address patients with symptoms.”

Carter said that LASIK is not for everyone, and the AAO recommended that ophthalmologists and patients utilize its educational resources on LASIK.

Healio.com/OSN spoke with three refractive surgery experts — John Berdahl, MD, George O. Waring IV, MD, and Richard Duffey, MD — who shared their opinions on the article and laser vision correction surgery.

 

John Berdahl
 
John Berdahl, MD

First and foremost, we took an oath to do the right thing for our patients, and we need to care and do what is in the best interest of our patients. This includes both before they have surgery by informing them of the options and the risks, and afterward, if a patient has an atypical outcome, we need to meet them in their moments of vulnerability.

Data are overwhelmingly positive in favor of LASIK. I have had LASIK on my own eyes. It is wonderful. I did not realize what the burden of contact lenses and glasses were until I was no longer burdened by them.

But, even though the data are overwhelmingly positive, that does not diminish the difficulty for the patients who have had an unfortunate outcome case. We need to do everything we can for them and do everything we can to advance the technology — not only to be able to fix issues, but to help them not occur in the first place.

I have never seen someone go blind from LASIK or PRK. In fact, it is exceedingly rare to have a patient who is not thrilled with the procedure. Contrasting that with contact lenses, especially those that have been worn improperly, I have seen multiple patients who lost vision in their eyes because of bad infections. So, the alternatives to LASIK are not entirely benign either.

Our job as physicians is to understand how patients want to use their eyes, which technologies are appropriate and help them reach the decision that is in their best interest.

George O. Waring IV
George O. Waring IV , MD

The recent New York Times article represents a wonderful reminder of the importance for public education on laser vision correction. Typically editorial, the article was designed to undermine the safety and efficacy of one of the most well-studied surgical procedures in history. What was unfortunately omitted was evaluation of decades of data that unequivocally demonstrate safety and efficacy of LASIK. What was also omitted was balance and bias. Peer-reviewed references support superiority of safety and patient satisfaction comparing LASIK with contact lenses; in addition, data on refractive surgeons having refractive surgery in perhaps the largest self-reported surgical analysis to date were somehow not mentioned.

All cataract and refractive surgeons should be inspired by this article to support efforts by the American Refractive Surgery Council to better educate the public on the safety and efficacy of laser vision correction. While no surgical procedure is without risk, modern laser platforms and screening diagnostics not uncommonly provide superior vision and patient satisfaction when compared with spectacles and contact lenses.

The global socioeconomic burden of uncorrected ametropia and presbyopia is undeniable. We are fortunate to be able to provide a service to improve quality of life, and thanks to the efforts of those before us, we do so in a data-driven manner.

References:

Kezirian GM, et al. J Cataract Refract Surg. 2015;doi:10.1016/j.jcrs.2015.10.027.

Price MO, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.04.003.

 

Richard J. Duffey
Richard J. Duffey, MD

The New York Times article is more of a critique of the FDA and its lack of long-term post-approval studies of LASIK. You could insert almost any procedure regarding FDA approval and build the article around it. The emphasis is that the FDA is not doing its long-term follow-up duty, but it became specific and sensationalistic about LASIK.

You see terms such as “lured” in the article, as if there is a conspiracy of non-disclosing physicians trying to place patients into the LASIK pool. This is an unfair overall painting of laser vision correction. LASIK surgeons use detailed informed consents (mine is 12 pages long), so I think it is unfair to paint with a broad brush the claim that most patients are poorly informed about these procedures.

Laser vision correction, based on my own experience and the literature, is a platinum standard for most surgeries, not just ophthalmic. But to achieve that platinum standard, there are three things that have to happen.

1. You have to have the best-chosen patients.

2. You have to have the best equipment. That means it has been upgraded every step of the way.

3. You have to have the best-trained surgeon and surgical team.

Informed consent is also key, but these three criteria are what separates less-than-perfect results from consistently great results.

Laser vision correction is not for everybody. A study by Frank Price specifically addressed the issues noted in the article. It looked at two arms of patients treated with contact lenses vs. laser vision correction and the long-term complications of dry eyes, visual aberrations and disturbances. The data were favorable of laser vision correction over contact lenses.

This New York Times article looked at dry eyes, headaches and visual aberrations, but sidestepped the fact that many of those complaints pre-existed the surgery. We screen for dry eye and significant ocular surface disease that will preclude someone from having an optimal LASIK outcome. We also screen closely for patients who have anxiety disorders and depression.

All of those factors go into proper patient selection that is necessary for the very best outcomes that LASIK can provide for our patients.

 

For more information:

John Berdahl, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls SD 57108; email: john.berdahl@vancethompsonvision.com.

Richard J. Duffey, MD, can be reached at Premier Medical Group, 2880 Dauphin St., Mobile, AL 36606; email: richardduffey@gmail.com.

George O. Waring IV, MD, can be reached at Waring Vision Institute, 735 Johnnie Dodds Blvd., Suite 101, Mt. Pleasant, SC 29464; email: gwaring@waringvision.com.

 

Disclosures: Berdahl reports he consults for many companies including Alcon, Bausch + Lomb and Zeiss. Duffey reports no relevant financial disclosures. Waring reports no relevant financial disclosures.

Earlier this summer, LASIK was the topic of a New York Times article in which patients described negative side effects and complications after the procedure, including dry eye, aberrations, blurred vision and burning.

The American Academy of Ophthalmology responded to the article, saying that while complications are possible, the risks are low.

“The risks of LASIK surgery are known in the ophthalmology community and have been studied consistently since the FDA approved the procedure 20 years ago,” AAO President Keith Carter, MD, said in the statement. “More than 300 peer-reviewed studies have shown that on average 95% of patients were satisfied with their outcome after LASIK surgery. A small number of patients have substantial and persistent symptoms after LASIK. This is why ophthalmologists continue to evaluate patient satisfaction and continue to evolve the surgery to improve patient outcomes and to address patients with symptoms.”

Carter said that LASIK is not for everyone, and the AAO recommended that ophthalmologists and patients utilize its educational resources on LASIK.

Healio.com/OSN spoke with three refractive surgery experts — John Berdahl, MD, George O. Waring IV, MD, and Richard Duffey, MD — who shared their opinions on the article and laser vision correction surgery.

 

John Berdahl
 
John Berdahl, MD

First and foremost, we took an oath to do the right thing for our patients, and we need to care and do what is in the best interest of our patients. This includes both before they have surgery by informing them of the options and the risks, and afterward, if a patient has an atypical outcome, we need to meet them in their moments of vulnerability.

Data are overwhelmingly positive in favor of LASIK. I have had LASIK on my own eyes. It is wonderful. I did not realize what the burden of contact lenses and glasses were until I was no longer burdened by them.

But, even though the data are overwhelmingly positive, that does not diminish the difficulty for the patients who have had an unfortunate outcome case. We need to do everything we can for them and do everything we can to advance the technology — not only to be able to fix issues, but to help them not occur in the first place.

I have never seen someone go blind from LASIK or PRK. In fact, it is exceedingly rare to have a patient who is not thrilled with the procedure. Contrasting that with contact lenses, especially those that have been worn improperly, I have seen multiple patients who lost vision in their eyes because of bad infections. So, the alternatives to LASIK are not entirely benign either.

Our job as physicians is to understand how patients want to use their eyes, which technologies are appropriate and help them reach the decision that is in their best interest.

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George O. Waring IV
George O. Waring IV , MD

The recent New York Times article represents a wonderful reminder of the importance for public education on laser vision correction. Typically editorial, the article was designed to undermine the safety and efficacy of one of the most well-studied surgical procedures in history. What was unfortunately omitted was evaluation of decades of data that unequivocally demonstrate safety and efficacy of LASIK. What was also omitted was balance and bias. Peer-reviewed references support superiority of safety and patient satisfaction comparing LASIK with contact lenses; in addition, data on refractive surgeons having refractive surgery in perhaps the largest self-reported surgical analysis to date were somehow not mentioned.

All cataract and refractive surgeons should be inspired by this article to support efforts by the American Refractive Surgery Council to better educate the public on the safety and efficacy of laser vision correction. While no surgical procedure is without risk, modern laser platforms and screening diagnostics not uncommonly provide superior vision and patient satisfaction when compared with spectacles and contact lenses.

The global socioeconomic burden of uncorrected ametropia and presbyopia is undeniable. We are fortunate to be able to provide a service to improve quality of life, and thanks to the efforts of those before us, we do so in a data-driven manner.

References:

Kezirian GM, et al. J Cataract Refract Surg. 2015;doi:10.1016/j.jcrs.2015.10.027.

Price MO, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.04.003.

 

Richard J. Duffey
Richard J. Duffey, MD

The New York Times article is more of a critique of the FDA and its lack of long-term post-approval studies of LASIK. You could insert almost any procedure regarding FDA approval and build the article around it. The emphasis is that the FDA is not doing its long-term follow-up duty, but it became specific and sensationalistic about LASIK.

You see terms such as “lured” in the article, as if there is a conspiracy of non-disclosing physicians trying to place patients into the LASIK pool. This is an unfair overall painting of laser vision correction. LASIK surgeons use detailed informed consents (mine is 12 pages long), so I think it is unfair to paint with a broad brush the claim that most patients are poorly informed about these procedures.

Laser vision correction, based on my own experience and the literature, is a platinum standard for most surgeries, not just ophthalmic. But to achieve that platinum standard, there are three things that have to happen.

1. You have to have the best-chosen patients.

2. You have to have the best equipment. That means it has been upgraded every step of the way.

3. You have to have the best-trained surgeon and surgical team.

Informed consent is also key, but these three criteria are what separates less-than-perfect results from consistently great results.

Laser vision correction is not for everybody. A study by Frank Price specifically addressed the issues noted in the article. It looked at two arms of patients treated with contact lenses vs. laser vision correction and the long-term complications of dry eyes, visual aberrations and disturbances. The data were favorable of laser vision correction over contact lenses.

This New York Times article looked at dry eyes, headaches and visual aberrations, but sidestepped the fact that many of those complaints pre-existed the surgery. We screen for dry eye and significant ocular surface disease that will preclude someone from having an optimal LASIK outcome. We also screen closely for patients who have anxiety disorders and depression.

All of those factors go into proper patient selection that is necessary for the very best outcomes that LASIK can provide for our patients.

 

For more information:

John Berdahl, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls SD 57108; email: john.berdahl@vancethompsonvision.com.

Richard J. Duffey, MD, can be reached at Premier Medical Group, 2880 Dauphin St., Mobile, AL 36606; email: richardduffey@gmail.com.

George O. Waring IV, MD, can be reached at Waring Vision Institute, 735 Johnnie Dodds Blvd., Suite 101, Mt. Pleasant, SC 29464; email: gwaring@waringvision.com.

 

Disclosures: Berdahl reports he consults for many companies including Alcon, Bausch + Lomb and Zeiss. Duffey reports no relevant financial disclosures. Waring reports no relevant financial disclosures.