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Patients report high satisfaction rate in FDA LASIK outcomes questionnaire

Issue: January 25, 2015

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After nearly 2 decades of clinical application in the U.S., LASIK has achieved high success and satisfaction rates. Many surgeons and patients attest to positive visual outcomes from LASIK, and LASIK has seen a recent uptick in patients choosing to undergo the procedure.

Data presented at the American Academy of Ophthalmology meeting in Chicago shed new light on patient-reported LASIK outcomes. Some experts believe the study, performed in response to reports of post-LASIK visual symptoms, speaks to the procedure’s safety and efficacy.

PROWL-1 and PROWL-2, part of the U.S. Food and Drug Administration’s LASIK Quality of Life Collaboration Project presented by Malvina B. Eydelman, MD, showed that overall the prevalence of visual symptoms, such as ghosting, glare, halos and starbursts, did not increase in patients undergoing LASIK.

The U.S. Trends in Refractive Surgery: 2014 ISRS Survey, presented at the AAO meeting by Richard J. Duffey, MD, showed that LASIK began to rebound in 2014 after a decade-long decline that Duffey attributed to the economic recession and publicized reports of poor outcomes and visual symptoms.

Kerry D. Solomon, MD, OSN Refractive Surgery Board Member, described the FDA study results as “very reassuring.”

The FDA report is scientific reassurance that LASIK is a very successful elective procedure, according to Kerry D. Solomon, MD.

Image: Staff M

“This is one of the largest prospective studies of LASIK ever done looking at quality of life,” Solomon said. “We [surgeons] support the idea of looking at prospective analyses of LASIK. We support the idea of looking at new information. It’s good for us, and it’s good for patients. We want to provide patients with good, accurate information so that patients can make good informed decisions.”

Many surgeons expected visual outcomes from the PROWL studies to exceed results of early trials for LASIK, according to Mitchell A. Jackson, MD, OSN Refractive Surgery Board Member.

“Before the onset of the PROWL studies, we already anticipated what the results of these studies were going to be … that the outcomes surpassed the expectations of what we expected anyway,” Jackson said.

Jackson attributed earlier reports of poor visual outcomes and visual symptoms, in part, to poor patient screening and selection.

“LASIK itself was not the problem,” Jackson said. “The problem in the past was being able to detect problem patients. You could do perfect surgery on a potentially problem patient not knowing that they were a problem patient because the technology may not have been up to date. There are a lot more things we can do preoperatively to screen out potentially bad patients for this procedure, even if you do perfect surgery on these patients. That’s a big improvement.”

Mitchell A. Jackson

Duffey, an OSN Refractive Surgery Board Member, said the FDA study reinforced the “predominant feeling” within the refractive surgery community that LASIK was “still a very robust procedure that, if anything, had only gotten better, not worse, over time.”

“The glare, halo and dry eye issues had been continuously addressed to the point where we were actually making huge strides and improvements,” Duffey said. “Some of that was preoperative testing, but some of it was also preoperative evaluations of patients where we intervened with dry eye problems, with ocular surface disease. We even precluded surgery on a greater number of patients because it turned out they were less-than-ideal candidates,” Duffey said.

According to Eric D. Donnenfeld, MD, OSN Cornea/External Disease Board Member, “The PROWL studies are among the most comprehensive prospective studies done by the FDA that show the efficacy of LASIK. What it shows is that LASIK improves quality of life, it improves visual symptoms, and like all surgery, there’s always some risks of side effects.”

“This was a very important study. I really appreciate the FDA, National Eye Institute and the Department of Defense working together to try to answer some of the questions that have been out there in the public,” Daniel S. Durrie, MD, OSN Refractive Surgery Section Editor, said.

Daniel S. Durrie

Visual acuity, patient satisfaction

PROWL-1 and PROWL-2 involved a Web-based questionnaire and patient interviews. PROWL-1 was conducted at the Navy Refractive Surgery Center in San Diego. PROWL-2 was designed to further validate the questionnaire and was conducted in a general patient population.

In PROWL-1, 224 patients completed a questionnaire at 3 months postop. In PROWL-2, 260 patients completed the 3-month questionnaire.

Mean patient age was 29.1 years in PROWL-1 and 31.5 years in PROWL-2.

At 3 months, 99% of patients in PROWL-1 and 96% of patients in PROWL-2 had binocular uncorrected visual acuity of 20/20 or better.

One eye in PROWL-1 and no eyes in PROWL-2 lost two or more lines of best corrected visual acuity at 3 months. No eyes had BCVA worse than 20/40 or more than a 2 D increase in cylinder.

“The visual outcomes are the best prospective outcomes that have been reported … . In fact, if you look at the [earlier] data, I think our 20/20 rate was around 60%, compared to 99% and 96% with this current study,” Solomon said. “It’s reassuring to know that the study showed, in a prospective, scientific fashion, the results that many of us who do LASIK surgery see every day. Our LASIK technology and visual results have improved over time. The vast majority of people see very well without needing correction.”

Overall, 0.2% of eyes lost two or more lines of BCVA from before surgery to 3 months.

“Again, really good visual outcomes and very low incidence of decreased vision,” Solomon said.

More than 96% of patients were satisfied with their vision at 3 months; 63.1% of patients in PROWL-1 and 53.5% of patients in PROWL-2 were “completely satisfied,” 31.1% of patients in PROWL-1 and 38.1% of patients in PROWL-2 were “very satisfied,” and 4.5% of patients in PROWL-1 and 4.6% of patients in PROWL-2 were “somewhat satisfied.”

With regard to results of LASIK surgery, 98% of PROWL-1 patients and 97% of PROWL-2 were satisfied. Concerning improvement in vision, 97% of PROWL-1 patients and 96% of PROWL-2 patients were satisfied. Regarding improvement in symptoms, 96% of PROWL-1 patients and 94% of PROWL-2 patients were satisfied.

Jackson said that the satisfaction rate exceeded that of many other surgical procedures.

“Overall, patients experienced improved symptoms after surgery with an extremely high satisfaction rate. That’s better than most things in medicine, not just in the eye world,” Jackson said. “There was a subset of patients who reported experiencing at least one new symptom postoperatively that was not present preoperatively, but this didn’t really diminish the overwhelmingly positive patient response.”

Overall results showed that up to 4% of patients — three patients in PROWL-1 and 10 patients in PROWL-2 — were dissatisfied with their vision at 3 months. In contrast, 14.2% of PROWL-1 patients and 8.2% of PROWL-2 patients were “completely dissatisfied” with their vision before surgery.

“Overall, the dissatisfaction rates in this study are very low, only 4%. While no surgery has 100% satisfaction rates, a 96% satisfaction rate is the highest of any surgical procedure reported,” Solomon said. “These rates are consistent with the previous published literature reviews. Even with the high success rates of LASIK, it’s still important to continue to look at the etiologies associated with patient dissatisfaction. If we can learn from this small group of dissatisfied patients, we can hopefully continue to make this procedure even more successful in the future. This study was fairly short, with only 3 months’ follow-up. The most common reason for patient dissatisfaction reported in the literature is residual refractive error (the need for an enhancement). A 4% enhancement rate is fairly typical. Enhancements were not permitted in this study. It’s likely that if enhancements were permitted and performed, the reported dissatisfaction rates would have been even lower. Also, some of the dissatisfaction at 3 months, if associated with dry eye, may actually have been made better with time,” Solomon said.

Visual symptoms, dry eye

Results of the FDA studies showed that prevalence of visual symptoms did not increase.

In PROWL-1, 29% of patients reported symptoms of ghosting before surgery and 7% reported ghosting at 3 months. In PROWL-2, 33% of patients reported symptoms of ghosting before surgery and 6% reported symptoms of ghosting at 3 months.

Symptoms of glare were reported by 41% of PROWL-1 patients before surgery and 23% of patients at 3 months. In PROWL-2, 37% of patients reported glare before surgery and 27% reported glare at 3 months.

Halos were reported by 41% of PROWL-1 patients before surgery and 37% of patients at 3 months. In PROWL-2, 51% of patients reported halos before surgery and 46% reported halos at 3 months.

Starbursts were reported by 48% of PROWL-1 patients before surgery and 34% of patients at 3 months. In PROWL-2, 56% of patients reported starbursts before surgery and 45% reported starbursts at 3 months.

“This is the first time that we’ve been able to show that patient symptoms, especially glare, halo and night driving problems, were significantly improved overall after surgery compared with before surgery,” Durrie said. “It was a very positive study that showed that LASIK surgery is very safe. It also showed that several of the symptoms that people worried about on average went down after surgery, which was very important.”

Eric D. Donnenfeld

Visual symptoms were “very bothersome” or “extremely bothersome” in up to 4% of patients without correction at 3 months. The prevalence of very and extremely bothersome glare in PROWL-1 decreased from 10.6% with correction preoperatively to 0.9% without correction at 3 months postoperatively.

“These are extraordinarily important findings that show that the results really do improve greatly,” Donnenfeld said.

Solomon said that patients were examined with correction before surgery and without correction after surgery.

“Even in that setup, people tended to have their symptoms made better afterward without correction compared to before with correction,” he said. “What is not known is that if we gave them correction, a thin pair of glasses for driving as an example or an enhancement, would those symptoms that were still present be made better? It’s unknown. Those data just weren’t reported.”

Durrie noted that dissatisfaction rates correlated with the typical enhancement rate.

“I think an important thing is that the patient symptoms have a tendency to improve,” Durrie said. “None of these patients were allowed to have enhancements, and 4% of the patients were dissatisfied with their vision at 3 months, which is about the enhancement rate we normally see — 3% to 4% of people who need a touch-up to be fully satisfied with their surgery.”

Less than 1% of patients had difficulty with or were unable to perform normal activities because of visual symptoms at 3 months.

Results showed that 44% of PROWL-1 patients and 45% of PROWL-2 patients who had no visual symptoms before surgery developed new visual symptoms 3 months after surgery.

“Those statistics are actually somewhat misleading,” Solomon said. “The entire study has 224 patients for PROWL-1 and 260 patients for PROWL-2. The percent of patients for the entire study that developed new symptoms is actually 14% for PROWL-1 and 12% for PROWL-2. It’s a small percentage, but it’s present and that’s important for us and our patients to know.”

Up to 30% of patients developed new dry eye symptoms after surgery.

Solomon and Donnenfeld both noted that dry eye typically improves after 3 to 6 months postop.

“What most people know is dry eye tends to develop in the majority of patients immediately after surgery and tends to resolve or get better in a lot of patients, but it will tend to get better in 3 to 6 months and sometimes longer,” Solomon said. “What we don’t know is in those patients that have new dry eye symptoms, will this resolve on its own over time?”

“[Dry eye], which is very common after LASIK, which everyone knows improves between 6 months and a year, they presented 3-month data as if it was long-term data, which is clearly not the case,” Donnenfeld said.

A need to focus on positives

Duffey said that, at first, he thought the FDA study was somewhat critical of surgeons.

“There was kind of a heavy emphasis on us surgeons doing a better job of informing the public about the major risk factors associated with the surgery,” Duffey said. “I just don’t see that much more visual symptoms afterward. If anything, I see more of a reduction of those problems than an increase. And despite the fact that I see dry eyes, it’s rarely an issue for patients even going into it with dry eye.”

Duffey said he later saw that the data, while focused on visual symptoms, were overwhelmingly positive.

“If you take a look at those patients who had visual symptoms before surgery — glare, ghosting, starbursts — overall there’s about a 35% reduction in those symptoms of patients that had them there before. That’s significant,” Duffey said.

Still, the PROWL studies should have examined activities related to quality of life, not just symptoms, according to Duffey.

“They called these quality-of-life studies, but all they looked at were negatives,” Duffey said. “They looked at glare, halos, starbursts, ghosting and dry eye problems, but nobody looked at increased color perception or increased enjoyment of vision during exercise, while at work, during leisure, playing sports. If you’re truly going to do a quality-of-life study, you really need to look at the positives as well, not just the negatives.”

Duffey said a study presented at the AAO meeting by Marianne O. Price, PhD, showed data on one important quality-of-life component: night driving. The study compared contact lenses, spectacles and LASIK.

“[There was] an 18% improvement in night driving in patients who had contacts or glasses first but had LASIK afterward, whereas those who started with contacts and ended with contacts, there was no change,” he said. “Dry eye problems in those who started with contacts and ended with contacts, they stayed about the same. And in those who started with glasses or contacts and ended with LASIK, there was about a 12% increase in dry eye. This was at 1 year. The increase in dry eye problems was considerably offset by the improvement in night driving vision.”

Surgeon survey

The U.S. Trends in Refractive Surgery: 2014 ISRS Survey showed that after declining steadily since 2001, LASIK volume began to rebound in 2013-2014.

“The original reduction, in my opinion, no doubt was from the economy. It started in 2001, after 9/11. So, we were seeing the effects of it,” Duffey said. “But I also think that there has been some negative publicity. When LASIK was down and out because of the economy, there was a little bit of a piling-on effect that existed with the media.”

The survey showed that surgeon-reported monthly LASIK volume peaked in 2001 and declined steadily from 2004 to 2013. However, LASIK saw a resurgence in 2014.

In 2014, 36% of survey respondents reported performing at least 25 LASIK procedures monthly and 12% reported performing at least 75 cases monthly. Less than 10% reported doing 75 cases monthly in 2012 and 2013.

Durrie said LASIK patient volume declined, in part, because many patients who had LASIK after the FDA approved it in the 1990s were not called back for long-term follow-up assessment.

“One of the major headwinds in the growth of LASIK surgery is that surgeons have not been seeing their patients back,” Durrie said. “I think that’s really hurting the growth of surgery more than any other single factor. We need to bring our patients back.”

Follow-up is critical because many patients who underwent LASIK a decade ago or longer are now presbyopic.

“The average age of those patients [in the FDA trials] was 38 years. So, a vast majority of those patients are now presbyopic. They’re back in reading glasses,” Durrie said. “Many of those patients, because they haven’t been seen by their surgeon and haven’t been followed up, feel like their LASIK wore off. It doesn’t have anything to do with that. LASIK surgery doesn’t wear off. They get presbyopic.”

Durrie said he is encouraging surgeons to follow up with LASIK patients.

“One of the things that I strongly have started encouraging now for surgeons is that it is time to bring all our patients back,” he said. “We do have solutions for presbyopia. We certainly can educate [patients] about the aging changes in their eyes. We can also educate them that their LASIK didn’t wear off. We have their topography. We can look at it and see that their LASIK surgery looks exactly the same as it did in their early follow-up.” – by Matt Hasson

Which factor weighs more heavily in the decision to accept or reject a candidate for LASIK: Patient personality or preoperative corneal findings?

Assess cornea, then address expectations

Rajesh K. Rajpal

In assessing patients for refractive surgery, I believe it is critical to determine that they have a healthy ocular surface and corneal topography as well as pachymetry before proceeding further with the evaluation. It is critical to educate patients about issues related to ectasia and to rule out any risk factors in their preoperative corneal evaluation process.

Patients who are younger, are higher myopes, have thin corneas or have atypical corneal topographies should in particular understand the risk of developing ectasia with LASIK as well as the option of surface ablation treatment. Assessing residual bed thickness and utilizing various proposed algorithms to evaluate the risk of ectasia are helpful in preoperative evaluation of LASIK patients.

Of course, once we have determined that the corneal curvature, corneal pachymetry and all other anterior segment findings are normal and that the patient is a good candidate, then it becomes critical to assess the patient’s goals and evaluate the appropriateness of surgery.

Rajesh K. Rajpal, MD, is an OSN Refractive Surgery Board Member. Disclosure: Rajpal is a consultant for Abbott Medical Optics, Alcon, Avedro and Bausch + Lomb.

Metrics and psychology weigh equally

Jodi Luchs

I think that both of those factors are probably equally important. Certainly, from a medical standpoint, you want to make sure that the cornea has the proper indices and metrics that make it a good candidate for doing surgery in terms of the outcomes that we would expect based on the preoperative characteristics.

That being said, it is also important to evaluate whether the person is a good candidate from a psychological or a psychosocial perspective. For example, despite having excellent postoperative vision, patients with certain type A or detail-oriented personality types may be more likely to have concerns about the quality of their vision and therefore may be less likely to be satisfied with their outcome.

We also know that patients who have a history of depression or anxiety are significantly less likely to be satisfied with their outcomes after refractive surgery. We need to look at these patients a little more critically as to whether or not we believe they are suitable candidates.

I think that the psychological profile is equally important to evaluate as the corneal metrics when you are looking at your potential candidates for refractive surgery. That critical analysis will improve both your patient outcomes and satisfaction, as well as physician satisfaction.

Jodi Luchs, MD, FACS, is a corneal and refractive surgeon practicing in Wantagh, N.Y. Disclosure: Luchs has no relevant financial disclosures.