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In October of 2009 the U.S. Food and Drug Administration (FDA), National Eye Institute (NEI), and the Department of Defense (DOD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK.
In October of 2009 the U.S. Food and Drug Administration (FDA), National Eye Institute (NEI), and the Department of Defense (DOD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK.1
The project aimed to determine the percent of patients who develop difficulties performing their usual activities following LASIK and to identify predictors for those patients.
Bill Tullo: Andy, in your experience, how safe is laser-assisted in situ keratomileusis (LASIK)?
Andrew Morgenstern: LASIK is one of the most commonly performed and studied procedures in the U.S. In preparation for this interview, I did a bit of homework. I expected you to ask this exact question, so I recently did a search on PubMed using the keyword “LASIK,” just to see how many studies were listed.
Just to give you an idea of how well studied it is: 5,216 studies were listed, just on PubMed alone. This does not include all of the case reports and un-refereed journals that have written on the subject. Just to give you a frame of reference, on Pubmed.org “Botox” had 1,904 studies; “breast augmentation” had 2,648 studies; and “keratoconus” had 4,790. It is obviously a well-studied procedure that, in my opinion, is very, very safe.
That said, there is no surgery without risk, and LASIK is not immune.
AM: Just as there are no surgeries that are without risk, very few patients can have outcomes that are either unwarranted or unpredictable. Some of these unexpected outcomes have made it into the public domain and have given rise to queries regarding the LASIK procedure.
It is the responsibility of the FDA to protect public health by assuring the safety, efficacy, and security of human drugs, products, and medical devices . The fact that FDA was concerned about LASIK outcomes and patient results is the right thing to do.
Just to give a little background, I attended an FDA meeting with my colleague John Potter, OD, in April 2008. The meeting was a public advisory panel of outside experts to listen to patient experiences with LASIK and consider how to improve information for patients and physicians.
In May 2009, the FDA issued a letter to eyecare professionals regarding the promotion and advertising of FDA-approved lasers used during LASIK. In 2011, it also issued a letter to the American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS) about disclosing risk information to patients.
As a result of all the good work the FDA did, it also launched a collaborative study with the NEI and the DoD to examine the potential impact on quality of life (QoL) from LASIK. The goal of the study was to determine the percentage of patients with significant QoL problems after LASIK surgery and identify predictors of these problems.
BT: Just so readers are clear on the vocabulary associated with these concerns, what is a patient reported outcome (PRO)?
AM: I am going to quote the FDA on this one since it is the authority. “A PRO is a report of a condition experienced and reported by the patient, not the health care provider.”1
According to the FDA, there were limited amounts of information and valid scientific data on PROs related to LASIK. This super group of organizations put all of the questions and concerns regarding LASIK outcomes on the table, rounded up some of the best researchers in the profession, and launched the Patient Reported Outcome with LASIK (PROWL) study.
AM: Great question, Bill. Because they had both a civilian organization and a military organization on board, they broke it down into two parts, PROWL/1 and PROWL/2. I am going to refer to my notes on this one since there is a bit of technical information.
Related: Measuring LASIK patient satisfaction
PROWL/1 (military) was performed through the DoD primarily at U.S. Naval Medical Center, San Diego, under the direction of Capt. Elizabeth M. Hofmeister, MD, MC, USN. Capt. Hofmeister is the refractive surgery advisor for Navy ophthalmology and an assistant professor of surgery of the Uniformed Services University (the U.S. Military Medical School).
Because there have been over 150,000 LASIK procedures since 2000 performed in the Navy alone, this is clearly important information. PROWL/1 was performed using a questionnaire to determine PROs in a patient population undergoing standardized LASIK treatment while developing a questionnaire to better evaluate patients’ reporting of visual symptoms and to assess the potential of those symptoms to impact a patient’s quality of life after LASIK. PROWL/1 was completed in 2014 with 262 participants.
PROWL/2 (civilian) was performed through the FDA recruiting subjects at five different locations in Indiana, California, Kansas, South Dakota, and Maryland. PROWL/2 was under the direction of Malvina Eydelman, MD.
Dr. Eydelman is the director of the FDA Division of Ophthalmic and Ear, Nose, and Throat Devices, Office of Device Evaluation, Center for Device and Radiological Health. This is part of the civilian sector in which a majority of LASIK procedures in the U.S. are performed. PROWL/2 was designed to further validate the questionnaire in a national, multicenter clinical study of the civilian population. PROWL/2 was completed in 2014 with 312 participants.
AM: Sure, Bill. The outcomes on LASIK were great. As expected, you can never have 100 percent perfection with any surgery. See the boxes for results that were reported by ASCRS and its highly experienced leadership (Ed Manche, MD; Eric Donnenfeld, MD; Doyle Stulting, MD; Kerry Solomon, MD; John Vukich, MD; and Daniel Durrie, MD).
• Only one of the 990 eyes lost three or more lines of visual acuity, and that eye saw 20/25 or better
• The prevalence of all visual symptoms and bothersome symptoms studied (ghosting, halos, glare, and starbursts) was less at six months after surgery without correction than it was preoperatively with best correction (PROWL-1)
• Patients reporting difficulty or the inability to perform usual activities due to visual symptoms improved or were completely eliminated following LASIK in both studies
• Visual symptoms throughout these trials must be understood in the context that there was no correction of residual refractive error. While the results are excellent, they would be even better if patients had been given the option to have additional LASIK or to wear glasses.
• 99 percent of patients had a binocular uncorrected vision of 20/20 or better at three months
• When asked how satisfied patients were with the results of their LASIK surgery, 98 percent reported being satisfied at six months and two percent were dissatisfied
• When asked “How satisfied are you with present vision?” 97 percent were satisfied at six months and three percent were dissatisfied. This is a significant improvement, because 73 percent were dissatisfied preop
• For each symptom index, up to 30 percent of patients reported new visual symptoms, while 91 percent of patients reported the resolution of symptoms they had prior to LASIK. Thus, three times more patients reported the resolution of preop visual symptoms than reported new visual symptoms
• Very few patients reported that visual symptoms negatively impacted their daily activities
• 21 percent (23 subjects) with a normal preop Ocular Surface Disease Index (OSDI) noted mild, moderate, or severe dry eye at six months. Sixty-five percent of patients with preop mild, moderate, or severe dry eye symptoms had normal OSDI scores at three months. Thus, three times more patients experienced an improvement in OSDI after LASIK than noticed new OSDI symptoms. Subjects were not followed long enough to observe the resolution of the dry eye symptoms, which was reported to occur in the literature.
• 96 percent of patients had binocular uncorrected vision of 20/20 or better at three months
• 97 percent were satisfied with their LASIK surgery at three months
• 96.2 percent were satisfied with their vision at three months, while 3.9 percent were dissatisfied. This is an improvement since 55.9 percent were dissatisfied preoperatively
• Up to one percent of subjects, without glasses or contact lenses, experienced a lot of difficulty with or were unable to do usual activities due to visual symptoms at three months. The ability of glasses or contact lenses to correct visual symptoms was not presented
• The prevalence of halos decreased from 51 percent (preoperatively) to 46 percent (at three months) in all patients following LASIK. Some 35 percent of subjects who had no halos prior to surgery developed new halos at three months. This was a subset of 31 patients out of the 260 patients examined at three months. The instances where preoperative symptoms (such as halos) disappeared following surgery were not presented
• 28 percent of subjects who had a normal preop OSDI noted mild, moderate, or severe dry eye at three months. The percent of patients who had mild, moderate, or severe dry eye preoperatively, who had a normal OSDI postoperatively was not presented
• The majority of the few dissatisfied patients reported visual symptoms, such as glare, halos, ghosting, or starbursts. The number of patients for whom refractive correction would have eliminated these symptoms was not presented
Subjects were not followed long enough to evaluate the resolution of dry eye symptoms that typically occur after LASIK, nor were they followed long enough to evaluate the long-term effects of LASIK.
AM: Absolutely. For the majority of my career, I have cared for refractive surgery patients. I have personally seen the positive life-changing experiences that they have enjoyed. Because of this, I am a firm believer that LASIK is a safe and effective procedure. My friends and family have all had it done. I am also a firm believer that LASIK is not for everyone. There is always risk and the potential for unwarranted and unexpected complications. Patients need to be made aware of this through a complete and thorough consent process. Also, patients deserve to have a full and complete evaluation prior to surgery to prove that they are well qualified for the procedure. If someone is not a good candidate, no surgery should be performed. My patients’ greatest successes have taken place when I have my “A” team working with me. It takes a great refractive team (clinic technician, surgical technician, optometrist, and ophthalmologist) to get these great results. Our technology and results are better than ever, and these PROWL results prove that point.
1. U.S. Food and Drug Administration. LASIK Quality of Life Collaboration Project. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm190291.htm#PROWL1. Accessed:
2. Hofmeister EM. Patient-Reported Outcomes with LASIK (PROWL-1) Results. Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421192.pdf. Accessed:
3. Eydelman MB. Patient Reported Outcomes with LASIK-2 (PROWL-2). Available at: http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421193.pdf. Accessed: