Eyeworld

77 December 2018 EW MEETING REPORTER by Alan Sugar, MD, Ann Arbor, Michigan. Dr. Sugar started with some background in the history of clinical research, noting several "scandals" in clinical research, including the Nazi experimentation in World War II and the Tuskegee Syphilis Study in the U.S. He also noted several scandals in ophthalmology, includ- ing the Tampa Trephine, which was a new device to cut donor cornea, approved for animal study and approved for clinical trial (though no patients enrolled), and data was presented at AAO in 1995. However, 60+ patients were treated outside of trial, without consent. Dr. Sugar went on to discuss ethical standards, reports, and ethi- cal principles developed, often as a result of some of these scandals. The Belmont Principles became the principles of ethics in the U.S., and the three principles are auton- omy, beneficence, and justice. The Belmont Principles have had an influence on clinical practice, appli- cability to non-research patient care (as well as research patient care), and recognize the decline of medical paternalism. He spoke about ClinicalTrials. gov. Federal law requires registration of trials, and summary results must be reported after FDA approval. That database includes almost 300,000 trials from around the world. Dr. Sugar discussed surgical innovations, physicians' conflicts of interest with treatment and research, and increasing public awareness. In conclusion, Dr. Sugar said that clinical research is an essen- tial part of improving patient care. Ethical issues are complex and critical. Consider these issues when designing studies and reading study reports. He also said that there is a need for systematic study to better understand and resolve these ethical issues in ophthalmology and to consider these issues in all clinical care. EW Editors' note: Dr. Sugar has no finan- cial interests related to his presentation. 3. Draw from lessons learned in refractive surgery. 4. Utilize valuable reference materials. To improve the informed consent process, Dr. Garg pointed to comprehension, competence, and speaking in lay terms. He said to make sure a patient understands what you said, and also make sure he or she is able to decide on a plan. Use an interpreter if necessary. Dr. Garg said he likes to use questionnaires and added that you should know both what your patient wants and what he/she doesn't want. It's important to re- main meticulous with preoperative procedures. Relating to educating and maximizing input from office staff, Dr. Garg said that this could involve discussion, your website, videos, and vision simulators. When drawing from lessons learned in refractive surgery, Dr. Garg said it's important to have an active dialogue with the patient. He encourages family members to at- tend appointments. It's a good idea to gauge the patient's personality and expectation level, provide him or her with the options for treat- ment, and explain the potential risks and complications. Finally, Dr. Garg discussed utilizing valuable reference materials and tools. These could include books and other procedure-specific consent information. You want to personalize to your patient, he said. Be honest about the incidence and occurrence of complications, and don't promise a particular visual outcome. It's also important to personalize risks. Editors' note: Drs. Solomon and Garg have no financial interests related to their presentations. Ethics of clinical research "The Future of Cornea in 3-D: Drugs, Devices, and Diagnostics" symposium was co-sponsored by the Cornea Society and Sektion Kornea of the German Ophthalmological Society (DOG). This symposium featured the Castroviejo Lecture on "The Ethical Basis of Clinical Research" given itizes customer service, customer satisfaction, elective products, and surgical outcomes. Dr. Solomon said it's important to meet with and empower staff. He stressed that learning to work as a group, including doing team build- ing exercises, is an important part of his practice. Dr. Solomon said to "devel- op a refractive cataract mindset." This includes developing refractive packages for your practice. He added that enhancements are a part of refractive cataract surgery, and it's important to address the possibility with the patient prior to surgery. Dr. Solomon also mentioned incorporating advanced technology into your practice, holding yourself accountable to metrics, and keeping your practice website up to date. Sumit "Sam" Garg, MD, Irvine, California, spoke about patient edu- cation and informed consent. Cata- ract surgery is refractive surgery, he said, mentioning the importance of preop evaluation, discussing patient expectations, discussing realistic goals, and doing a comprehensive exam. Dr. Garg shared four ways of improving the informed consent process: 1. View informed consent as an edu- cational process rather than a legal document. 2. Educate and maximize input from office staff. much time fixing these sutures that have broken over the years). He rec- ommended using Gore-Tex sutures, though noted that this is off-label. Editors' note: Dr. Cionni has financial interests with Alcon and Morcher (Stuttgart, Germany). ASCRS symposium A symposium co-sponsored by ASCRS focused on "Refractive Cata- ract Surgery for the Comprehensive Ophthalmologist." The session was chaired by Edward Holland, MD, Cincinnati, chair of the ASCRS Program Committee, and Vance Thompson, MD, Sioux Falls, South Dakota, EyeWorld Refractive editor. Panelists at the session includ- ed Blake Williamson, MD, Baton Rouge, Louisiana, Preeya Gupta, MD, Durham, North Carolina, Eliza- beth Yeu, MD, Norfolk, Virginia, John Berdahl, MD, Sioux Falls, South Dakota, and William Wiley, MD, Cleveland. Kerry Solomon, MD, Mount Pleasant, South Carolina, presented on how to have satisfied customers, build your practice, and develop a true cataract refractive practice. He noted that new technology, great outcomes, a compassionate and caring office culture, and a focus on customer service are all important factors. Dr. Solomon tracks out- comes at his office, and he prior- View videos from the AAO Annual Meeting: EWrePlay.org Sam Garg, MD, discusses meibomian gland dysfunction and its importance in patients undergoing cataract surgery and refractive surgery.

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