FDA's LASIK Quality of Life Project

FDA LASIK Quality of Life Project Introduction & background
LASIK surgery is among the most frequently performed eye operations worldwide. According to an estimate, about 1 million people undergo LASIK surgery each year in the United States alone. A LASIK surgery is generally intended to minimize a person’s dependence on spectacles or contact lenses by permanently changing the shape of the cornea (the clear covering of the front of the eye) using an excimer laser. The objective is to modify the focusing ability of the eye, and, hence, enhancing a person’s ability to see objects more clearly. While there is no defined time frame yet as to when the project will be completed, the tentative date for the completion of this study is by the end of 2012.

FDA’s Role in regulating LASIK & other medical procedures
Contrary to the popular belief, in its strict sense, the FDA does not monitor regulate physicians or surgeons nor operations or procedures but only the safety, effectiveness and sale of the medical devices that are used by these doctors in the US. In simple terms, FDA does not have the authority of putting a ban on a specific kind of operation or surgery. However, based on the practical and credible evidence, FDA can impose certain conditions related with the use of the devices in any medical or surgical procedure.

For example, while the FDA (Food & Drug Administration, USA) has approved the lasers & tools used in the LASIK procedure in people 18 years and older with stable eyesight, it advises to avoid this procedure during pregnancy and in those having eye diseases in the past.

FDA’S Lasik-Quality of Life Project
In July 2009, the US Food and Drug Administration (FDA) initiated a specific study called "Lasik-Quality of Life" to assess significant quality-of-life related issues & concerns that the patients might have after LASIK eye surgery. This FDA-managed study is funded by the US government agencies.

Objectives of the LASIK Quality of Life Project
The main objectives of the LASIK Quality of Life Project are:

  • To determine the safety & effectiveness of the lasers used in LASIK: It was proposed that a better understanding of the risks of LASIK could lead to a reduction in patients who experience various complications or undesirable effects from the surgery.
  • To determine and measure the extent of improvement in vision which a successful LASIK surgery can bring to the people, leading to an enhanced quality of life

Phases of LASIK-Quality of Life Project
There are three different phases of this study that are considered to be completed by the end of 2012. Each phase is aimed to evaluate different aspects of a patient's quality of life after LASIK surgery.

Phase 1: The first phase began in July 2009 and included an online questionnaire to evaluate patient-reported side effects and quality-of-life concerns that may occur after LASIK surgery.

Phase 2: This phase is designed to evaluate patient-reported quality of life and level of satisfaction after LASIK surgery. It consists of a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), where U.S. military personnel opting for LASIK will complete the questionnaire before the LASIK surgery and at one, three, and six months after surgery. Patient enrolment for this phase is expected to begin by March 2011.

Phase 3: It will be conducted in multiple centers on nation-wide basis and will be aimed to understand the influence the LASIK procedure has on quality of life after LASIK surgery in the general public. This part is expected to end by 2012.

Importance of LASIK-Quality of Life Project
Simply speaking, the FDA’s LASIK-Quality of Life project provides an opportunity to benefit both patients and doctor by enhancing knowledge of an already well-understood eye surgery. The study will, in fact, focus on studying LASIK’s impact on various factors of a person’s life style and daily routine such as performing daily life activities, from vision and comfort to driving, jobs and work schedule and family life to career, physical performance and external looks. It will also note and take into consideration any reported side effects after LASIK e.g. some of the difficulties reported by people undergoing LASIK include dry eye, eye pain / discomfort, enhanced glare and haloes.

Conclusion
Reporting adverse events to the FDA is vital to better understand the safety and effectiveness of eye lasers used in LASIK surgeries and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements. This is the main focus of the much-awaited, currently undergoing FDA’s LASIK-Quality of Life study. In addition, it will also further strengthen the already established effectiveness of LASIK procedure in eye health enthusiasts.

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