This post originally appeared in the ARSC Insight Blog.
What You Need To Know About PROWL
Two new studies published online in the JAMA Ophthalmology shed new and important light on patient experiences after LASIK surgery.
What is PROWL?
The goal of the FDA’s PROWL (Patient Reported Outcomes with LASIK) studies was to validate a new questionnaire that gives patients an accurate and complete way to report their experience with vision and LASIK. The questionnaire – a first – provides a better, more consistent collection the patient’s reporting of visual symptoms, dry eye symptoms, as well as patient satisfaction after LASIK, overall satisfaction with vision, daily functioning and well being.
“The PROWL studies are important,” said American Society of Cataract and Refractive Surgery President Kerry D. Solomon, M.D. “This is the first scientifically validated patient questionnaire for LASIK and it has a lot of potential. It provides not only an entirely new set of data that we hope will provide more insights on LASIK outcomes for patients, but also a platform for better patient education and, ultimately, more educated decisions about vision correction. With time and use of the questionnaire, surgeons will get accurate and consistent information from the patient’s perspective.”
What was learned and why it matters?
First, the studies acknowledge the body of clinical evidence confirming the safety and effectiveness of LASIK. With that knowledge, the study’s authors wanted to further explore the patient experience with LASIK, including reports of visual and ocular symptoms and satisfaction with vision and LASIK. Their findings suggested that with a valid questionnaire, patients more accurately assess and report symptoms and satisfaction.
In order to test the performance of the questionnaire – validate it from a scientific perspective – two small sample populations of LASIK patients were given the survey of patient reported outcome (PRO) questions.
- PROWL-1 was conducted at a military center with 262 active-duty Navy personnel (ages 21-52 years of age).
- PROWL-2 had 312 civilian participants (ages 21-57 years of age) located at five private practice and academic centers around the country.
The observational study focused on the functionality of the questionnaire. However, as a result of the LASIK procedures being performed, some additional data was reported:
- Both groups reported high satisfaction rates, between 96 and 99 percent
- A small but significant subset of patients – those without symptoms prior to LASIK – experienced new visual symptoms such as glare, halos, or starbursts, or mild, moderate, or severe dry eye symptoms, 3 months after surgery.
- Overall, the prevalence of visual symptoms and dry eye decreased after having LASIK and improved over time.
- Through the questionnaire, very few patients reported their symptoms impacted their daily activities or well-being.
Has our understanding of LASIK side effects changed?
From a clinical perspective, absolutely not. LASIK side effects are well-known and understood through a huge volume of research. However, what is significant is that patient reported methods offer an entirely new set of data for clinicians and researchers to tap into. This helps to characterize the experience with LASIK more broadly and, perhaps, more accurately moving forward.
Side effects from LASIK are rare, recent studies suggest fewer than 2 percent of patients undergoing modern LASIK report symptoms. This relatively low percentage of patients experience side effects during the recovery and healing process and these include dry eye and visual symptoms such as glare, halos and starbursts. Typically, these symptoms resolve with time or, occasionally, with additional treatment. In particular, those patients who choose to have the most advance treatment profiles with the latest technologies have been shown to have higher levels of satisfaction with the procedure.
“As we have said many times before, LASIK is surgery and can produce post-operative effects,” said Dr. Solomon. “Factors such as the patient’s expectations and understanding of LASIK have an important bearing on outcomes. It’s also true that not all people who undergo LASIK are good candidates for the procedure. The ultimate key to steady improvement in LASIK outcomes is patient education, effective counseling before and after the procedure, and effective screening to make sure that people who undergo LASIK are good candidates. LASIK is one of many vision correction options, and patients should choose and be guided toward the options that are right for them.”
Importantly, doctors want to thoroughly understand those patients who do experience symptoms and the PRO questionnaire may well represent an important advancement in accurately reporting and characterizing symptoms.
The PROWL survey instrument consists of more than 68 questions intended to help patients self-assess and report a range of issues including, satisfaction with current vision, satisfaction with LASIK surgery, and the existence, bothersomeness, and effect on usual activities of visual symptoms including: double images, glare, halos and starbursts. The questionnaire incorporates both written definitions of symptoms and images to help illustrate the symptom and severity levels. The baseline PROWL questionnaire took study participants on average of 20 minutes to complete.
So, what’s the bottom line?
The PROWL study affirms our ongoing commitment to careful, thorough patient counseling about the risks for side effects and symptoms from LASIK. Using validated questionnaires, such as the one created for the PROWL study, is an excellent vehicle for collecting accurate and consistent information from patients. LASIK practices will have access to the PROWL questionnaire (LINK) and should strongly consider incorporating its use as it may allow eye care professionals and patients to make more educated decisions about vision correction. If you are among the thousands of people considering vision correction options, you owe it to yourself and your vision to become as informed as possible about LASIK and other procedures. If you are reading this, you have found the ARSC Insight blog and we encourage you to subscribe.
Earlier this year, a team of researchers wanted to determine if modern LASIK had improved patient outcomes when compared to when LASIK was first approved by the FDA. The team reviewed more than 4,400 clinical studies from around the world and concluded in a paper published in the Journal of Cataract and Refractive Surgery that LASIK is among the safest and most effective vision correction procedures. This vast data review on LASIK is the latest to be added to the library of more than 7,000 peer-reviewed, published studies.
There has never been a better time to have LASIK. The American Refractive Surgery Council recently wrote, “There are as many reasons [to opt for LASIK] as there are candidates. But all of them want what LASIK has to offer – superb vision correction without the hassle of glasses or contact lenses.”
Should I consider LASIK today?
LASIK today is the best it’s ever been. In addition to continuous improvements in technology and technique, surgeons also draw on an extensive base of knowledge to evaluate the patient and perform the procedure.
The scientific literature reports patient satisfaction rates (globally) of more than 98 percent. And, data from a recent three-year study showed contact lens wearers who chose LASIK were more satisfied with their vision than those who stayed in contacts, and that LASIK patient satisfaction also increased over time (while the satisfaction rate among contact lens users decrease).
Is LASIK for everyone?
No, and any reputable LASIK surgeon will use everything at their disposal to evaluate and determine if an individual is a good candidate.
Surgeons today will discuss the procedure in depth with you and will ensure you understand the risks as well as the benefits. A range of medical conditions, including thin corneas and other eye deformities, can mean that LASIK won’t work well for you.
(If you are told you are not a good or even excellent candidate for LASIK, do not be discouraged. It means you are working with a qualified surgeon who has your best interest at heart. There are likely other alternatives to help you achieve your vision goals.)
Opting for LASIK means understanding what the experience will be like – what happens in surgery, what you’ll experience afterward, how long until side effects disappear, and how your vision might continue to change over time.
Do your homework and ask questions.
Ultimately, and only after you have all of the information, you need to determine if LASIK is right for you. If you are a good candidate for LASIK, think about what you want out of the procedure, and be prepared with questions to ask. Articles like this can help you get ready for your consultation. Candidates who come to see us and discuss their vision correction options have done their homework. They have independently confirmed that LASIK is safe and effective, and they know the advantages it offers over other forms of vision correction. We are here to help and will answer any question you may have.
By Dr. Eric Donnenfeld,
Contact lenses are a wonderful invention. They enable people to see better, to shed cumbersome eyeglass, and feel better about how they look.
But contact lenses can also cause inflammation, pain and dry eyes. More than fifteen percent of people suffer from a problem called contact lens intolerance, where discomfort and dryness is so great they have to give up their lenses.
Moreover, contact lenses can also cause dangerous eye infections. A recent report from the Centers for Disease Control warns that 20 percent of infections linked to wearing contact lenses led to serious eye damage.
Many of my own patients are upset and frustrated because they can no longer wear contact lenses.
Fortunately, I can help them, thanks to several new approaches, including an innovative new eyelid cleanser called Avenova.
The most common cause of contact lens intolerance is dry eye, which occurs when the eye doesn’t have a sufficient film of protective tears. That problem, in turn, is caused or exacerbated by bacteria and tiny parasitic mites that live on the eyelids. The microbes not only irritate sensitive eye tissue, causing pain and inflammation (and sometimes, serious eye infections), they also make enzymes that break down a crucial oil layer that protects the tear film.
But we can now successfully tackle these problems. A new device called LipiFlow applies heat and controlled pressure to the inner eyelid, unblocking the glands that produce the crucial oil. Another device, named BlephEx, deep cleans the lid margins with a disposable sponge.
In addition, I’ve had great results with Avenova® with Neutrox from NovaBay Pharmaceuticals. This has become first line therapy. Avenova uses a formulation of pure hypochlorous acid (named Neutrox) to remove the bacteria and mites, reducing chances of infections. It also inactivates the bacterial enzymes, helping to stabilize the tear film and improve comfort. So far, every single one of my patients suffering from contact lens intolerance or other chronic eye conditions has been helped by simple twice-daily wipes with Avenova. It truly is a breakthrough.
A leader and innovator in eye care, Eric D. Donnenfeld, MD, FACS, is a board-certified ophthalmologist, clinical professor of ophthalmology at NYU and past president of the American Society of Cataract and Refractive Surgery
I spend most of my day talking with patients about their vision; how to protect it and make it better. It’s what I love to do. The very best conversations I have with patients include lots of questions – particularly important for those who are considering an elective procedure such as LASIK. I decided I wanted to write about the top questions I want you to ask me about LASIK. Here are the first five:
How safe is LASIK?
The safety of LASIK is proven by a tremendous amount of scientific evidence gathered by hundreds of clinical researchers. Based upon all this data, and it has one of the largest data sets ever compiled concerning a medical procedure, that LASIK is considered extremely safe.
Am I a good candidate and if so why?
This should be determined by a thorough evaluation of your vision and eyes in a comprehensive consultation with your LASIK surgeon. Being a good physical candidate is important, but it is also necessary to include your personality and lifestyle in making the decision to move forward.
What are the chances I will obtain the vision I desire?
As with the data supporting the safety of LASIK, there is a vast amount of research supporting the effectiveness of the procedure. The latest lasers and diagnostic technologies have further refined the performance of LASIK to deliver visual outcomes that are better than ever with more than 95 percent of patients achieving 20/20 vision and nearly 100 percent of patients achieving at least 20/40. The most recent review of the LASIK research worldwide shows that more than 96 percent of patients are satisfied with their vision.
Will I need to ever wear glasses again in the future?
Most patients no longer need to rely on glasses or contacts, and the ones that do see their dependence on corrective eyewear drastically reduced. While the results from LASIK surgery are considered to be permanent, you will still be susceptible to age-related eye conditions such as presbyopia and cataracts. Should you develop one of these conditions, you may need to use reading glasses or additional treatment.
What can I do to improve my results prior to, during, and following the procedure?
Having a thorough understanding of the procedure, what to expect during the recovery and carefully following the post-operative medication and activity regimen are all essential to a successful outcome.
When can I go back to doing normal activities?
Typically, patients return to work the next day and are back to their normal routine within a week or two.
We strongly recommend, once you’ve had a thorough LASIK evaluation and it is determined you are a good or even excellent candidate for LASIK, you get information from a variety of sources. We are here to answer your questions and want to help you with this decision in any way we can. We also understand the need to do some independent research. In addition to talking with your friends and family who have had LASIK, the American Refractive Surgery Council offers a lot of information about vision correction procedures and is a good resource.
Let’s face it, most people who wear contact lenses have a love-hate relationship with them.
Ah…the exhilaration of that first pair of contact lenses when for the first time you, who have known the struggle with glasses, are able to see without anyone knowing that, in reality, you can’t. But, that sense of freedom can be fleeting once you realize that contacts, too, have limitations. And, for many, the disappointment sets in when signs of contact lens intolerance appear. It begins with a slight irritation or dry eye; but over time, it can become a sight-threatening issue.
What is contact lens intolerance?
Contact lens intolerance happens when a person’s eyes get irritated when they put in their contacts – becoming bothersome enough that they want to take them out and stop wearing them. Symptoms can be temporary and range from a mild gritty or stinging sensation to more serious issues such as chronic dry eye, abrasions, infections and even corneal ulcers. And for some, these complications are sight-threatening – for up to 1 in 500 contact lens users per year – according to the Centers for Disease Control and Prevention, citing a study published in 2008.
What causes contact lens intolerance?
There are several possible factors. It could be that the fit isn’t right. Perhaps age or hormone changes are contributing factors. Certainly the over-wearing of lenses and the resulting deposits developing on the surface of the lens is as issue, as is not cleaning lenses properly, or sensitivity to lens cleaning solutions; all are associated with the spectrum of symptoms in contact lens intolerance. Whatever the cause, people with contact lens intolerance are better off looking for alternative solutions, such as switching to glasses or having LASIK eye surgery to correct their vision permanently without needing corrective lenses of any type.
Even people who don’t suffer from contact lens intolerance eventually find that the appeal of contacts begins to fade. All types of contact lenses reduce the amount of oxygen reaching the cornea – the front of the eye where the contact resides. Even with proper care and meticulous hygiene, this can lead to an increased risk of eye problems.
A recently published study of long-term (<5 years) contact lens users showed that, over a 3-year period, their level of satisfaction with using contact lenses decreased significantly: from 63 percent down to 54 percent. The study also showed that people who used to use contacts, but then chose to have LASIK eye surgery, had a much higher level of satisfaction with their vision that only improved over time. Importantly, LASIK has a much lower risk of sight threatening infection – 1 in 10,000 according to clinical research.
If you wear contacts and experience symptoms such as red, irritated eyes, ongoing dry eye symptoms, pain or swelling, it’s vital you don’t ignore any of these symptoms. To protect the health of your eyes and vision, please schedule a consultation with Dr. Donnenfeld at Long Island LASIK immediately as you may be contact lens intolerant. It may be time for you to consider other forms of vision correction, such as LASIK.
If you’re considering LASIK, you’ve no doubt asked yourself important questions: Is it safe? Is it effective? Is it right for you? Maybe you’ve already asked the same questions of your LASIK surgeon. If not, you should.
Here’s another question that might be on your mind – when your surgeon responds to those questions, how does he or she know what to tell you?
The answer is science. LASIK, like all other medical procedures, drugs, and medical devices, is the subject of extensive research. The research – we call it “clinical research” – is carefully designed to tell us whether medical treatments work, how well, and for what kinds of patients.
How does clinical research work?
Clinical research is a scientific medical exploration or investigation into the performance of a drug, medical device or treatment regimen with the primary goal of determining whether it is safe and effective for patients. It is conducted over an extended period of time – months and sometimes years – by scientists. The reports of these studies are incredibly detailed, running 20 to 100 pages or more.
The research begins with a hypothesis. A hypothesis is an educated guess about the treatment and its ability to provide a certain benefit. Research is then conducted to test whether the hypothesis is true or false. Research can take many different forms, but essentially data is collected, analyzed in the context of the hypothesis and then the findings are reported. The findings of clinical research determine which drugs, devices and treatments are approved for use and often compares them to previously approved treatments. Importantly, clinical research serves to build our knowledge about prevention, treatment, and diagnosis.
LASIK has been the subject of a tremendous amount of clinical research. In fact, LASIK is one of the most studied elective procedures performed today. More than 9,000 patients participated in FDA clinical trials alone from 1993-2005. Over time, a tremendous amount of clinical research into LASIK has been conducted – to date more than 7,000 peer-reviewed published studies, in fact – to confirm the procedure is both safe and effective as well as look into other important aspects of LASIK. This includes studies that help refine what makes a patient a good or bad candidate for the procedure, and techniques and technologies that can reduce the potential for side effects such as dry eye, glare and halos.
Clinical studies have tested the many improvements in LASIK since the procedure was first approved. In medicine, technologies and techniques evolve and advance over time. LASIK is no different. Today’s excimer lasers – the lasers that reshape the cornea to improve vision – are more precise and easier to work with than earlier models. Newer lasers and technologies are able to customize the procedure to the specific shape and thickness of a patient’s cornea and treat a broader range of vision impairments. All of these advances lead to better visual outcomes and a safer procedure for more people.
Research doesn’t just answer your questions – it answers ours as well. The clinicians – the scientists – who work with LASIK are committed to an ongoing process of improvement in the procedure. We continually ask questions as a means of finding potential in LASIK. There is a reason “quest” is the root of the word “question.” This illustrates that scientific exploration is a process, a path – not necessarily a destination. The question is the beginning, not the end.
It is important to understand what clinical findings say – and what they don’t. This can be difficult, because news stories about new clinical studies often grab a dramatic headline, but miss the details and the nuance that are part of every research report. No one study has a final, definitive answer about any medical treatment, device, procedure or drug. By definition, a study has a very specific scope – a specific question it is trying to answer. While the results of a single study can be compelling, interesting and encouraging, they are only a piece of a bigger and growing body of science. This is why you have to be cautious about any reporting that describes dramatic conclusions from a single study.
In the case of LASIK, there is tremendous confidence, based upon an extraordinarily large amount of clinically-based evidence, that the procedure is safe and effective. It isn’t perfect, because nothing is. However, it ranks among the most thoroughly investigated, most effective and safest procedures performed today.
To find out more about LASIK, start here. Then contact us, so we can start a conversation about what LASIK can do for you.
At Long Island LASIK, we have a proud and long-standing tradition of contributing to the body of science in vision and eye health. As part of that work, we participated in the recently published study, “Modern Laser in Situ Keratomileusis Outcomes.” The study, a scientific literature review of more than 4,400 peer-reviewed clinical studies, found patients are experiencing better visual outcomes than ever before and that the procedure has improved over time. The findings underscore the tremendous amount of research both supporting and advancing the science of LASIK. The data clearly show LASIK results have only improved with innovation and better patient screening protocols.
For those considering LASIK, the good news from this study is that LASIK continues to be a very safe and effective vision correction procedure that has only gotten better over time.
Dr. Eric Donnenfeld and our entire team love to hear from patients about life after LASIK. Many patients tell us how their favorite activities, like exercise and traveling, become easier and more enjoyable without having to depend on glasses or contact lenses to see clearly. We are very pleased to have helped improve quality of life for so many people! Here, Dr. Donnenfeld shares some examples of activities that are more convenient and rewarding after LASIK. Continue reading
If you need glasses or contacts in order to see your way through life, it is likely at some point, perhaps in a moment of struggle with your eyes, vision or lenses, you’ve thought about what life would be like without a vision problem. In that moment, you’ve probably thought about LASIK vision correction surgery. And then you say to yourself: “Yeah…someday.”
Having LASIK is a choice and so is putting it off. Every choice comes with certain outcomes – even putting something off. With a decision like vision correction, you may not think about the consequences of NOT having it done, but here are a few:
You Might Be Wasting Money
A lifetime of vision correction expenses adds up to a surprisingly large amount of money – thousands of dollars. LASIK is an investment, but very doable for most budgets with the very economical financing options available today. And every day, week, month and year you don’t pay for glasses, frames, lenses, solution, cases, etc. is a day you are recouping your investment in your vision. So, the sooner you have vision correction surgery, the sooner you begin saving money. Those who make the investment in their 20s and 30s can expect at least a decade or two of excellent vision (eventually everyone needs reading glasses), meaning they will certainly save more than they spend on the cost of LASIK.
You Might Be Compromising the Health of Your Eyes
This is particularly true if your choice of vision correction is contact lenses. Contacts require diligence. Maintenance is mandatory. The fact is, a lot of people abuse their lenses and put their eyes and vision at risk from infection. We see this frequently in young adults who take their health for granted. The reality is the risk of sight-threatening infection from long-term contact lens use is greater than that of LASIK. And choosing eyeglasses doesn’t eliminate risk – ask anyone who has fallen or been hit in the face while wearing them. The fear of damage and injury due to broken frames or lenses is very real.
Importantly, two recent research studies show that contact lens wearers who choose LASIK are much happier with their vision after surgery, while the longer people wear contacts, the less satisfied they are with them. In fact, patients under the age of 40 report being especially satisfied with LASIK as opposed to wearing contacts or glasses.
You Might Be (Artificially) Limiting Your Life
Do you like to travel? Are you into playing sports or working out? Do you like camping and hiking? What about going to the beach?? Each of these circumstances and scenarios should be the fun part of life – and they are, even when you wear glasses and contacts. But let’s be honest, they do present a challenge. Dirt, sand and water threaten the safety of contacts. Hauling contact lens supplies around is a hassle. Prescription sunglasses are expensive and fashions change pretty frequently. The list of compromises you are making in life with glasses and contacts can be pretty long. If you are fortunate enough to pursue your passions in life, you owe it to yourself to experience it all without the limitations of corrective lenses.
So if you’ve been thinking about have LASIK “someday,” these are just a few of the reasons to think again and make your vision and lifestyle a priority. Today’s modern technologies make LASIK a safe and terrific vision correction option for nearsightedness, farsightedness and astigmatism – the latest research confirms up to 96 percent of patients are satisfied with their results. There really has never been a better time than now to find out if you are a candidate for the procedure and if LASIK is right for you.
See Eric D. Donnenfeld, MD featured on CBS’s report on a new lens for Cataract Surgery here: FDA Approves New Lens For Cataract Patients