David W. Parke II, MD

May 2008

A recent flurry of LASIK news stories was a direct result of the April 25 FDA Ophthalmic Devices Panel meeting. The panel heard from patients and physicians on the safety and side effects of the procedure. At the conclusion, the panel sent a clear message to the medical community: we need to work harder at screening prospective patients, informing them of their risks and, frankly, managing expectations.

At the meeting, the Academy and the American Society of Cataract and Refractive Surgery (ASCRS) worked very hard to ensure that the full scientific and medical picture of LASIK – with its long track record of safety and high percentage of satisfied patients – was presented to the FDA advisors. We are grateful to Steve Schallhorn, MD, and Peter McDonnell, MD, who represented the Academy and International Society of Refractive Surgery of the American Academy of Ophthalmology before the panel.

Based on the overall testimony, which included several patients with bad LASIK outcomes, the FDA panel is reviewing several recommendations about updating device labeling and the information made available to patients considering the surgery.

The Academy is spearheading several initiatives that address the ODP’s needs. As you may know, the Academy and ASCRS are working in tandem with the FDA and the NEI to fund and design a prospective research study on LASIK outcomes and the impact the surgery has on patient quality of life. Learning more about LASIK patients’ quality of life provides a chance to understand the factors that most impact patient satisfaction and, ultimately, to improve the procedure and its results for patients. Richard Abbott, MD, the Academy’s Secretary of Quality of Care, will co-chair the task force for the study, which is planned to begin in 2009.

The Academy is also developing a new “K-card” to be given to patients by their LASIK surgeons, which captures a patient’s preoperative keratometry readings and refraction. It is often difficult to track down this critical data years later, when the patient is in need of cataract surgery or additional eye care. We are exploring ways to store this information digitally for easy retrieval.

In addition, we are encouraging our members to report adverse events associated with LASIK to the FDA via its MedWatch system.

Resources for You and Your Patients
The Academy has a variety of resources for physicians performing LASIK and patients considering the surgery. Professional resources include:

• “Refractive Errors & Refractive Surgery” Preferred Practice Pattern®
• LASIK advertising guidance, developed in conjunction with the Federal Trade Commission
• News and research on the procedure through the Ophthalmic News and Education (O.N.E.) Network (one.aao.org)
• Refractive surgery consent forms and other risk-management recommendations from OMIC (www.omic.com)

For your patients, the Academy is building upon its solid foundation of patient education materials to provide the public with reliable, objective information and resources to assist in making decisions about laser eye surgery. Patient resources include:

• Comprehensive information about LASIK and other laser eye surgeries on the Academy’s EyeSmart Web site (www.GetEyeSmart.org)
• A wide variety of patient educational materials found at the Academy’s online store

We know that any surgery has its risks. Managing that risk is the best option for more satisfied patients and even greater success. I encourage you to use the Academy resources to safeguard your practice and provide your patients with the best quality care.

>> More on the LASIK hearing