Medical Devices

LASIK Quality of Life Collaboration Project

In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project aimed to determine the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients.

At the time we developed our project, there was a limited amount of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is a report of a condition experienced and reported by the patient, not the health care provider.

Most LASIK studies used tools, such as questionnaires, to assess visual symptoms, but only after the surgery. The studies in the LQOLCP assessed visual symptoms both before and after their LASIK surgery to identify changes over time. The studies also measured the impact symptoms directly had on performing usual activities, which had not previously been done.


Pilot

The pilot phase involved comparing PROs using web vs. paper questionnaire. This phase of the project was completed in 2011 with 118 participants.

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Phase I

The first phase involved the development of a web-based instrument for assessing PROs and ensures that the instrument is easy to use and understand, and adequately covers LASIK issues. This phase also involves interviews with patients contemplating LASIK as well as patients who have experienced poor outcomes and those who have experienced positive outcomes. This phase of the project was completed in 2011 with 22 participants.

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Initial Study/PROWL-1

The initial study determines an initial estimate of the prevalence of PROs in a select patient population - to estimate the percentage of patients developing difficulties performing their usual activities following LASIK. To do so, the questionnaire was used in an initial study of a patient population undergoing standardized treatment at the US Naval Medical Center San Diego. This phase of the project was completed in 2014 with 262 participants.

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Initial Study/PROWL-2

This initial study further validates the questionnaire and prevalence in a national, multi-center clinical study in a civilian population. This phase of the project was completed in 2014 with 312 participants.

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Measurement Tool

The project produced a new questionnaire that can be used to more thoroughly assess candidates before LASIK surgery and to monitor them for visual symptoms after LASIK surgery, and in further research to identify which patients are likely to experience serious difficulties.

In addition to a literature search and expert interviews, we used focus groups with patients and cognitive interviews to develop the project questionnaire so that it could assess the presence of visual symptoms and their severity, as well as measure the impact those symptoms had on a patient’s ability to function. In developing the questionnaire, we used images and clear definitions for the visual symptoms (ghosting/double vision, halos, glare, and starbursts) for patients and health care providers, which built a well-defined and consistent baseline for understanding our findings and for future research.

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Study Results

The problems some study participants developed after having LASIK surgery, such as difficulty driving at night or in sunshine, severely impacted a patient’s daily living, and included debilitating vision symptoms (seeing starbursts, glare, ghosting, or halos) and severe dry eye. The two initial studies found less than 1 percent of patients experience difficulty performing their usual activities following LASIK surgery.

When LQOLP was designed, we intended to conduct a larger study to identify predictors for those patients who develop difficulties performing their usual activities following LASIK. We estimate that such a study would need approximately 2,500 patients. However, given our findings from PROWL 1 and PROWL 2, a very large clinical study would be necessary to more accurately estimate the prevalence and find useful predictors for these patients, because there are so few. The FDA is unable to conduct a study of such size, although we are pleased to have our questionnaire available to researchers interested in this area.

Based on our initial analyses of our studies:

  • Up to 45 percent of participants, who had no visual symptoms before surgery, reported at least one visual symptom at three months after surgery.
  • Participants who developed new visual symptoms after surgery, most often developed halos. Up to 35 percent of participants with no halos before LASIK had halos three months following surgery.
  • Up to 30 percent of participants with no symptoms of dry eyes before LASIK, reported dry eye symptoms at three months after their surgery. This is consistent with previous studies.)
  • Less than 1 percent of study participants experienced “a lot of” difficulty with or inability to do usual activities without corrective lenses because of their visual symptoms (halos, glare, et al) after LASIK surgery.
  • Participants who were not satisfied with the LASIK surgery reported all types of visual symptoms the questionnaire measured (double vision/ghosting, starbursts, glare, and halos).

The findings from this study will help to refine our current thoughts on the labeling for LASIK devices which will be incorporated into our patient labeling guidance. In addition, we will ensure our website reflects these findings to better inform consumers of the potential outcomes following LASIK.

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Page Last Updated: 10/20/2014
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