EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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May 2012 EW NEWS & OPINION Societies: FDA guidance is too restrictive by Jena Passut EyeWorld Staff Writer In the journal … May 2012 LASEK using a 213-nm solid-state laser Sunil Shah, F.R.C.S., Amy L. Sheppard, Ph.D., Jennifer Castle, B.Sc., David Baker, B.Sc., Phillip J. Buckhurst, Ph.D., Shehzad A. Naroo, Ph.D., Leon N. Davies, James S. Wolffsohn, Ph.D. In this case series involving 245 eyes, investigators considered how a Pulzar Z1 213-nm solid-state laser fared in performing LASEK. Patients with pre-op refractive errors ranging from –9.5-6.5 diopters were in- cluded here. Investigators determined that 97.9% of patients who un- derwent the treatment were within 1 D of intended spherical equivalent at the 6-month mark, 89.4% were within 0.5 D, and 60.4% were within 0.25 D. When it came to mean cylinder power, at the 6-month mark this dropped from –0.98-0.14 D. The conclusion reached was that for LASEK treatment of myopia, hyperopia, and astigmatism, the 213-nm solid-state laser was safe, accurate, and effective. Resident experience with toric and multifocal IOLs M. Allison Roensch, M.D., Justin W. Charton, M.D., Preston H. Blomquist, M.D., Nalini K. Aggarwal, M.D., James P. McCulley, M.D. Investigators in this case series set out to consider the outcomes of resident surgeons implanting an AcrySof Toric or multifocal AcrySof ReSTOR premium IOL (Alcon, Fort Worth, Texas). Of those who received the toric IOL, 90% attained 20/40 uncorrected distance visual acuity (UDVA) or better, and 57% were at 20/25 or better. For those receiving the multifocal lens, 78% attained UDVA of 20/25 or better and 94% saw 20/40 or better. In 94% of cases, near acuity was determined to be J3 or better. Residents expressed a strong comfort level with using the pre- mium lenses in survey results. The conclusion reached here was that when it comes to premium IOLs, residents can be taught to use these with the expectation of attaining good success rates. Review/update: Biaxial micro-incision versus conventional coaxial cataract surgery Ji-guo Yu, Ph.D., Yun-e Zhao, M.D., Jie-liang Shi, M.D., Ting Ye, M.D., Nan Jin, M.D., Qin-mei Wang, M.D., Yi-fan Feng, M.D. To compare biaxial micro-incision cataract surgery and conventional coaxial phacoemulsification, investigators here conducted a comprehen- sive literature search. They found that in 1,064 eyes that had undergone these procedures, when it came to corrected distance visual acuity, mean percentage of endothelial cell loss, laser flare photometry value, changes in central corneal thickness, or surgical complications, there was no sig- nificant differences between the two techniques. For those that under- went the biaxial procedure, however, effective phacoemulsification time was statistically shorter and needed mean phacoemulsification power was significantly lower. In addition, the biaxial technique was found to induce less surgical astigmatism. A recent FDA policy pro- posal places "unjustifiable restrictions" on the ex- change of information about off-label uses of drugs and devices, according to a comment letter submitted by ASCRS and the Alliance of Specialty Medicine. The comment letter was submit- ted at the end of March in response to the draft guidance released by the FDA in December 2011, titled, "Re- sponding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." In the guidance, the FDA pro- hibits physicians speaking in a speaker's bureau, firm-sponsored events, including webinars and other engagements, from respond- ing to questions from audience members about off-label uses, even when those uses have become the standard of care. The speaker would have to immediately cease the questioning and refer the audience member to the company's medical or scientific department for a written response. "Unbelievably, this means that speakers would be unable to discuss or even answer questions regarding the use of perioperative antibiotic prophylaxis, sulcus placement of posterior chamber IOLs (following capsular rupture), and laser vision correction of residual refractive error following a premium IOL. These are all off-label practices," said ASCRS President David F. Chang, M.D., clinical professor of ophthalmology, University of California, San Fran- cisco. "Although I understand that the FDA wants to discourage compa- nies from actively promoting off- label uses of drugs and devices, some of these indications have become well-established standards of care. This new proposal is far too extreme and shortsighted. By intruding on legitimate physician education, it ultimately compromises patient care and safety." The draft guidance places unjus- tifiable restrictions on the exchange of scientifically valid data at indus- try-sponsored events, according to Doyle Stulting, M.D., Woolfson Eye Institute, Atlanta. continued on page 12 EyeWorld @EWNews Follow EyeWorld on Twitter at twitter.com/EWNews Are you a fan of EyeWorld? Like us on Facebook at Find us on social media facebook.com/EyeWorldMagazine 11