Patient satisfaction after LASIK, as measured by unvalidated surveys or questionnaires, is neither scientific nor a reliable indicator of LASIK safety or efficacy. LASIK surgeons report high patient satisfaction even in cases with poor night vision and sight-threatening complications. The “Hawthorne effect” 1 proposes that patients may rate their level of satisfaction with the LASIK procedure higher in an effort to please their physician.
The FDA called a public meeting in April 2008 to discuss issues concerning patients’ experiences with LASIK. Several weeks prior to meeting, the American Society of Cataract and Refractive Surgery (ASCRS) — a professional group of LASIK and cataract surgeons — issued a press release2 announcing findings of a literature review led by Kerry Solomon, M.D. alleging a “95.4% global LASIK satisfaction rate”. The full text of the article was not published until April 2009. Nineteen articles representing only 2,199 patients were retained by the authors in this “LASIK world literature review”3, although 16 million patients had undergone LASIK worldwide according to the press release. Eighty four percent (16/19) of the articles used questionnaires that were not validated.
Solomon et al report; “Although this database [of 19 articles] also includes information on visual outcomes, night vision symptoms, and dry eyes, for the purpose of this paper, the analysis of the database focuses specifically on patient satisfaction and quality of life.” In other words, the authors chose not to disclose complication rates. Only two articles in the literature review actually report quality of life after LASIK… one is a study of 100 patients in Bihar, India,4 and the other is a study of 49 patients in Ireland.5 In the study performed in India, the reason the females sought LASIK was to enhance marriage prospects. All levels of satisfaction in this review, ranging from “very” to “somewhat” were grouped and reported as “satisfied” patients.
An inspection of articles cited in the ‘global LASIK literature review’ reveals alarmingly high LASIK complication rates:
- “Twenty four percent of patients reported glare and night vision problems postoperatively.” O’Doherty M, O’Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.
- “Overall, 30.0% of the subjects reported experiencing halos, 27.2% reported glare, and 24.5% reported starbursts.” Bailey MD, Mitchell GL, Dhaliwal DK, et al. Patient satisfaction and visual symptoms after laser in situ keratomileusis. Ophthalmology 2003;110:1371- 8.
- “Commonly reported symptoms included eye soreness in 43 patients (44.3%), tearing in 20 (20.8%), itching in 38 (39.6%), and moderate dryness or worse in 28 (20.8%).” Schmidt GW, Yoon M, McGwin G, et al. Evaluation of the relationship between ablation diameter, pupil size, and visual function with vision-specific quality-of-life measures after laser in situ keratomileusis. Arch Ophthalmol 2007;125:1037-42.
- “Night vision was considered worse or much worse than before surgery by 33.8% of patients….After surgery, 40.9% of patients reported experiencing more difficulty with night driving than before surgery.” Tahzib NG, Bootsma SJ, Eggink FA, Nabar VA, Nuijts RM. Functional outcomes and patient satisfaction after laser in situ keratomileusis for correction of myopia. J Cataract Refract Surg. 2005 Oct;31(10):1943-51.
- “Twenty-nine percent reported reduced night vision clarity following LASIK and 27% noted more eye dryness following LASIK.” CLAO J. 2001 Apr;27(2):84-8. Patient satisfaction after LASIK for myopia. Miller AE, McCulley JP, Bowman RW, Cavanagh HD, Wang XH.
As shown, articles in this ‘global LASIK literature review’ database that reported dry eyes and night vision problems confirm double-digit rates of these potentially debilitating complications of LASIK. Although Solomon et.al. did not report the incidence of dry eyes and night vision problems, they do state that poor quality of life scores after LASIK were associated with “regression, dry eye, poor vision in low light, and halos at night” — a fact conveniently missing from Dr. Solomon’s “95.4% of LASIK patients are satisfied” sound bite.
Curiously, the FDA gave ASCRS advanced notice of the planned public meeting on LASIK6 – enough time to conduct a “LASIK world literature review” and prepare talking points for the media. The spin generated by ASCRS surrounding this public meeting included misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective”. At the public meeting, Dr. Solomon was asked by FDA consultant, Jayne Weiss, M.D., for clarification concerning FDA’s role in ASCRS’ public statement and literature review. Dr. Solomon admitted, “This was independent from the FDA or the National Eye Institute. Yes, ma’am.”
In 1994 as LASIK was being introduced, Dr. Leo Maguire of the Mayo Clinic cautioned against using patient satisfaction as a measure of success. He said: “A keratorefractive patient may simultaneously be happy with the result of surgery and have degraded vision – how can refractive surgery be a potential public health problem if patients are happy with the results? Inherent in this question is the assumption that a patient without complaint is a patient without optical degradation. That argument does not hold up to closer scrutiny. The keratorefractive literature contains disturbing examples of patients who have visual handicaps that place themselves and others at significant risk for nighttime driving accidents and yet they are happy with the results.”7
A Consumer Reports survey of LASIK patients finds that LASIK falls short of expectations for most who had the procedure. This Consumer Reports survey of laser eye surgery patients, which was published online in August 2009 (www.consumerreports.org) found that “nearly two-thirds said they were disappointed to find that they still had to wear glasses or contact lenses at least occasionally”. Fifty-three percent of the respondents reported at least one side effect after surgery, and 22 percent were still experiencing side effects six months later. Nearly a quarter (24 percent) of “not highly satisfied” respondents said they regretted not learning more from people who had laser eye surgery before them.
Likely, surgeons are focusing on patient satisfaction to divert attention away from high complication rates inherent in the LASIK procedure.
Physicians have an obligation to place patient welfare over any personal profit motives. However, highly lucrative outpatient surgical procedures such as LASIK eye surgery have created a new breed of physician/entrepreneurs who are willing to simply sell what is profitable to a trusting and unsuspecting public. These ‘salesmen’ are masquerading as healers.
- Mayo E. The Human Problems of an Industrial Civilization. New York, NY, MacMillan, 1933.
- Accessed 10/12/2009 at http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm.
- Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.
- Akhaury RK, Verma NP, Kumar R. Patient motivation for laser in situ keratomileusis in the state of Bihar. J Refract Surg. 2004;20(suppl):S727-9.
- O’Doherty M, O’Keeffe M, Kelleher C. Five year follow up of laser in situ keratomileusis for all levels of myopia. Br J Ophthalmol 2006;90:20 -3.
- EyeWorld Week Vol. 13 No. 7 March 10, 2008. Accessed 10/11/2009 at http://www.eyeworld.org/ewweek.php?id=507.
- Maguire LJ. Keratorefractive surgery, success, and the public health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.