Eyeworld

EW NEWS & OPINION 18 Dr. Chang: The IOL has arguably benefited and impacted more indi- viduals than any other implantable device in medical history. It is there- fore hard today to imagine why IOLs were under siege in 1980. What was prompting the FDA hearings? Dr. Kratz: There were three different battles that threatened to shut down IOL implantation in the U.S. The first strong opponents were aca- demic ophthalmologists. Some con- vinced Medicare to declare in 1973 that IOL surgery was experimental and would therefore not be reim- bursed by Medicare. After presenting IOL outcomes to the American Academy of Ophthalmology Com- mittee, we were able to demonstrate sufficient safety and to change this Medicare ruling. The second battle was fought in California, where most of the IOLs were manufactured and also im- planted (due to so many of the early adopters being California surgeons). In 1975, the California state FDA (at the urging of the federal FDA) declared that IOLs were drugs rather than devices and therefore were under the state FDA's jurisdiction. The California FDA declared that IOLs were experimental and banned the manufacturing and implantation of IOLs in California, but not in the other 49 states. However, two-thirds of all American IOLs were manufac- tured in California. For California ophthalmologists, implanting IOLs would result in loss of your medical license. We were shut down until we successfully sued the California FDA and got the ruling reversed. The final battle in 1980 was the biggest one. The U.S. FDA also de- clared IOLs a drug and thus under their jurisdiction. Ophthalmologists were required to report all adverse events involving IOLs to the FDA. These adverse event reports were used at an FDA hearing in Washing- ton, D.C. in another effort to stop the use of IOLs on a national level. Dr. Chang: Do you think that these FDA hearings could have potentially killed or at least significantly stalled adoption of IOLs? Dr. Kratz: Sure, because they were shooting very hard for control. They said intraocular lenses are drugs and the FDA needed to control drugs. Testifying against IOLs was Sidney Wolfe, MD, from consumer advocate Ralph Nader's group. He counted every little tiny thing as a complication—if you have a small subconjunctival hemorrhage and you have a little something else you can have 3 or 4 complications in just 1 eye. But he acted like it was 5 or 6 different eyes. So he was able to say that the IOL complication rate was 50%. He was misleading and not being exactly honest in his approach. Dr. Chang: Who was Robert Young and how did you meet him? Dr. Kratz: He was the Emmy Award- winning actor who played Dr. Marcus Welby, a family practitioner on a popular weekly ABC television series. Everybody knew Marcus Welby. His program Marcus Welby, M.D. became the #1 rated show, and he always saved his patients by diagnosing remarkable diseases that no one knew very much about. He was America's doctor. I first met Robert Young as a patient who had nearly mature bilateral cataracts. The Marcus Welby, M.D. TV series was still in progress, but he was nearly blind. To see his food he'd have to bring his face al- most to the plate. He was having a terrible time. Before filming a scene, he would count the number of steps so that he knew exactly how far to go before he should turn. The staff would ask him, "Where do you want your cue cards?" He would say, "Forget them, I can't see them." His vision was pretty well gone. Fortunately, his vision was restored with phacoemulsification and IOLs. I also did his wife's cataracts. It made a big difference in their lives and we became quite friendly. We went to their 50th wedding anniver- sary, which was a rare milestone for a couple in Hollywood. Dr. Chang: Whose idea was it to have Robert Young testify? How were you able to convince him to do this? Dr. Kratz: The American Intra-Ocu- lar Implant Society, which was the predecessor to ASCRS, picked three patients to testify on behalf of IOLs at the FDA hearings in Washington. May 2014 by David F. Chang, MD Marcus Welby, MD, knew best A t the time of my residency in the early 1980s, Richard Kratz, MD, was universally regarded as one of the leading cataract surgeons in the world. At the 2013 ASCRS•ASOA Symposium & Congress, Dick was deservedly inducted into the Oph- thalmology Hall of Fame. In his acceptance speech, he humbly pointed out that he "neither invented phaco nor the IOL, but tried to advance cataract surgery in some small way." In actual fact, Dick is largely unsung as one of the most important phaco pioneers. Phaco was initially taught as an anterior chamber technique. Imagine using only con- tinuous 100% power ultrasound (no surgeon control) without viscoelastic on unfragmented nuclei prolapsed into the anterior chamber, and you can understand why corneal decom- pensation was so common with this tech- nique. Posterior chamber phaco was easier on the cornea, but with a can opener capsulo- tomy, no viscoelastic, no hydrodissection, and no concept of nuclear fragmentation and disassembly, surgeons would simply sculpt a stationary nucleus at 100% continuous phaco power until they reached the bottom—often simultaneous with posterior capsular rupture and nuclear descent. I trained at a time when the majority of resident surgical attendings considered phaco to be a dangerous and unproven alternative to large incision manual ECCE. Dick introduced two key concepts that not only saved phaco, but paved the way for it to become the predominant technique. The first concept was performing nuclear emulsi- fication in the iris plane—equidistant from the cornea and the posterior capsule. The other was to use a second hand instrument to maneuver the nucleus. Thanks to Dick, many of us were able to master phaco using the Kratz technique of prolapsing the subinci- sional pole of the nucleus, removing this portion with phaco, and then rotating the resulting smaller diameter nucleus with the second instrument. Dick turns 94 this month and still attends nearly every ASCRS meeting. If you speak to him, you would never guess that this amiable, modest, and unpretentious man is not only a living legend, but truly belongs on the Mount Rushmore of phaco's "founding fa- thers." Ironically, it wasn't just his innovative techniques but also some luck involving one of his patients in 1980 that probably saved IOL surgery. David F. Chang, MD, chief medical editor Dr. Kratz (left) was inducted into the ASCRS Ophthalmology Hall of Fame in 2013. He was presented with the award by his former partner and inventor of the foldable IOL, Thomas R. Mazzocco, MD. Source: ASCRS continued on page 20 Chief medical editor's corner of the world

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