Copyright Dickinson FDA Webview at www.fdaweb.com. Republished with permission.
After a decade of stonewalling injured patients’ complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH last week lifted their hopes for a change of heart at a one-hour meeting — then dashed them five days later in a 9/18 statement that doubled down on the agency’s existing position: LASIK is safe and effective for nearly everyone. At issue in the long-simmering controversy is the level of adverse effects that should be tolerated — FDA accepts industry claim of less than 2% while the patient group cites PMA data showing rates as high as 20%, pointing out that for a medically unnecessary, elective cosmetic procedure it should be close to 0%. LASIK marketers promote it as an alternative to wearing glasses.
Morris Waxler, the retired CDRH branch chief who approved the LASIK indication for the devices and led the patient group that met with CDRH 9/13, said the devices produce “2% catastrophic problems and 20% chronic daily pain and vision distortions.” FDA is “trapped by the facts and owned by industry,” he told FDA Webview in an email after the meeting. His presentation recited data in AMO Manufacturing, Nidek and Alcon PMAs showing that 2% of patients have worse than 20/40 vision without glasses 12 to 24 months after surgery, 2%-20% had vision distortions 6-12 months or longer after surgery and a similar number suffer dry and painful eyes 3-12 months after surgery.
Among other issues raised by the 6,000-member patient group was their characterization of an FDA-produced video on the agency’s Web site, LASIK Surgery and its Risks, as so “promotional” for the procedure that it could have been written by the LASIK industry. In a critique of the video, group member and former CDRH advisory committee consumer representative Paula Cofer cited the following excerpts:
Video: “Leaps and bounds have been made in advancements to LASIK in the last decade.”
Cofer: In terms of harm caused by the surgery, technological advancements in LASIK devices have made little differences in LASIK outcomes.
Video: “As in any surgery, there are risks involved.”
Cofer: A certain degree of risk is acceptable when the surgery is medically necessary. Because LASIK is unnecessary and performed on a healthy eye the acceptable complication rate should be virtually zero.
Video: “Most people are satisfied with the outcome of their surgery.”
Cofer: Short-term “satisfaction” is neither scientific nor a reliable indicator of LASIK safety or efficacy. Moreover, LASIK complications may present months or years after the surgery.
Video: “You may require additional surgery to get the desired outcome.”
Cofer: This statement recklessly minimizes risk of multiple surgeries for which the FDA has no data establishing safety and effectiveness. Retreatments are riskier than primary LASIK.
Cofer was especially critical of a government-funded post-LASIK quality of life study known as Patient Reported Outcomes with LASIK, also known as PROWL, published in the 1/2017 issue of JAMA Ophthalmology. She said LASIK surgeons with conflicts of interest “were involved in the study design and as investigators in the clinical arm of PROWL … key conclusions of PROWL are bogus, or falsely positive for LASIK.”
She told FDA Webview the group had hopes of a breakthrough with FDA after the agency agreed to meet with them, and based on informal interactions after the meeting, which was convened as an outgrowth of commissioner Scott Gottlieb’s patient outreach effort. Then came FDA’s 9/18 statement in an email from press officer Alison Hunt, who attended the meeting:
“We recognize the need to engage the wider stakeholder community and we value patient input. We are committed to ensuring that patients considering LASIK can make informed decisions based on objective information concerning the benefits and risks of the surgery. The FDA, in collaboration with the National Eye Institute and the Department of Defense, launched the LASIK Quality of Life Collaboration Project. The results of the studies conducted as part of this collaboration have demonstrated that more than 95 percent of participants were satisfied with their vision following LASIK surgery. However, importantly, of those participants with no visual symptoms before surgery, almost half reported at least one visual symptom at 3 months after surgery (most often halos). No more than 2 percent of all participants reported difficulty performing daily activities without corrective lenses due to visual symptoms (starburst, ghosting, halos, glare) after LASIK surgery.
“This is precisely the type of information that patients and providers need to make informed decisions about whether LASIK is appropriate for individual patients.
“As part of the Quality of Life Collaboration Project, Patient-Reported Outcomes with LASIK, or PROWL, studies were designed to fill a void that was not being addressed by any researchers in the ophthalmologic community. Their purpose was to evaluate questionnaire scales (including some newly created scales) to measure symptoms, patient satisfaction, and expectations before and following LASIK surgery. The studies did this and we have published the results in peer-reviewed publications (here and here). In the more than 500 patients studied, the development of debilitating symptoms after LASIK was uncommon. Over the last decade, via regular website updates, presentations at professional meetings and other public communications, the FDA and its partners have kept the public informed throughout the study process to reflect agency activities, progress and plans for the study. As with any area of study, more research will help further our understanding of the benefits and risks of this procedure.
“The development of a scientifically rigorous and validated questionnaire was a resource-intensive and complicated task. The questionnaire can now be used to consistently assess the prevalence of visual symptoms in LASIK patients. Multiple studies and clinical sites are already utilizing the questionnaire to assess clinical outcomes in patients undergoing LASIK and we anticipate that most future studies submitted to support marketing approval of LASIK devices will utilize the PROWL questionnaire (in whole or in part) to ensure that the public continues to have access to objective, useful information concerning the symptoms associated with LASIK.
“The FDA reminds patients considering the LASIK procedure to thoroughly discuss the benefits and risks of the procedure with their health care professional. The FDA has made a significant amount of consumer-focused information available on its website about the benefits, risks and expected outcomes associated with LASIK.
“Our work with LASIK is ongoing. In addition to transparently communicating the results of the PROWL studies as described above, we have incorporated the studies’ findings into our device review program. In addition, we are in the process of developing a LASIK patient labeling guidance that will provide recommendations to industry about how to clearly communicate risks of LASIK to patients. As we continue to monitor the safety and effectiveness of LASIK we will also explore additional ways that we can improve the quality of information available to the public about LASIK and ways to ensure that FDA receives better information about problems with LASIK.
“For more information, please see: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/default.htm”
Cofer commented: “I am extremely disappointed in FDA’s statement. I actually thought that the FDA listened to us, and I left the meeting hopeful for the first time in 10 years. Today those hopes were dashed because the FDA continues to parrot the LASIK industry’s misleading claims of high patient and stands behind its faulty analysis of PROWL.”
Waxler commented: “Notice FDA did NOT provide even one complication rate! They make vague references to risk/benefit with absolutely no numbers. The PROWL study was conducted under the best conditions and they found 2% had persistent difficulties with daily vision tasks. They continue to promote LASIK. Pathetic response from a public health agency.”