AAO updates media on key ophthalmic issues

November 10, 2008

In the past year, the world of ophthalmology has seen some significant headlines. They captured numerous issues that included patient satisfaction and quality of life, infectious outbreaks, and controversy over treating patients with unapproved drugs. In a press briefing at the American Academy of Ophthalmology (AAO) meeting, "2008 year in review: An update on key issues in the news," ophthalmologists provided an update.

In the past year, the world of ophthalmology has seen some significant headlines. They captured numerous issues that included patient satisfaction and quality of life, infectious outbreaks, and controversy over treating patients with unapproved drugs. In a press briefing at the American Academy of Ophthalmology (AAO) meeting, "2008 year in review: An update on key issues in the news," ophthalmologists provided an update.

In his presentation, "Lucentis versus Avastin for the treatment of wet age-related macular degeneration," George A. Williams, MD, described the benefit of both drugs. Ranibizumab (Lucentis, Genentech) is FDA approved with the verified ability to improve visual acuity by 25% to 40%, whereas bevacizumab (Avastin, Genentech), which has gained a worldwide consensus of its safety and efficacy, is less expensive but has not been through rigorous testing.

The Comparison of Age-Related Macular Degeneration Treatments Trials study, which will have four arms, is going to compare monthly ranibizumab with monthly bevacizumab and bevacizumab as needed compared with ranibizumab as needed. All patients will be seen every month for at least 2 years. The study aims to determine which patients need aggressive vascular endothelial growth factor therapy and which do not, whether the two drugs are similar in safety and efficacy, and it will look at economics.

A Fusarium keratitis outbreak in 2006 and Acanthomoeba keratitis outbreak in 2007 led an FDA ophthalmic devices panel on June 10, 2008, to review the existing guidelines for contact lens solution and product safety. Thomas L. Steinmann, MD, MetroHealth Medical Center, professor of ophthalmology, Case Western Reserve, Cleveland, OH, went over some recommendations from the panel in his presentation, entitled "Contact lenses: Trends and public policy, 2006 to 2008."

Recommendations to the FDA for consumers were to improve contact lens care regimens and for manufacturers to change the wording of labeling to coincide with the new standards of care. The FDA has responded and will recommend manufacturers include only "rub" directions for use in labeling, convene workshops on Acanthamoeba and other microbiological test methods, develop standardized methods for Acanthamoeba with standardized organizations, revise guidance documents that will include real world test methods, and update the contact lens Web site.

Richard L. Abbott, MD, health science clinical professor of ophthalmology and Thomas W. Boyden Endowed Chair in Ophthalmology, University of California, San Francisco, presented a talk entitled, "LASIK: Patient satisfaction and quality of life issues." He discussed the most recent attempts to qualify and study the changes in quality of life in those patients who are dissatisfied by LASIK.

A proposed prospective national study is under way to investigate the level of patient satisfaction, changes in patient quality of life, and factors associated with satisfaction after LASIK. The AAO is working with the FDA on study details. The time line is approximately 3 years for the completion of the study and any detailed questions should be directed to the FDA. In the mean time, the AAO has produced LASIK resources for the public, including a consumer guide. For physicians, the AAO is providing informed consent and risk management information as well as K cards, which list patient pre- and postoperative refractive surgery information.

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