Monthly Archives: November 2016
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