Eyeworld

FEB 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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44 EW CATARACT February 2012 Cataract competition on steroids by Maxine Lipner Senior EyeWorld Contributing Editor Difluprednate and prednisolone acetate face off C ataract surgery these days often has a strong refrac- tive component, which has practitioners doing their utmost to maximize early outcomes. Recent findings showed that nearly twice as many patients remained free of edema when on high-dosed, pulsed di- fluprednate (Durezol, Alcon, Fort Worth, Texas) versus prednisolone acetate (Pred Forte, Allergan, Irvine, Calif.). In a study e-published in the June 2011 issue of the American Jour- nal of Ophthalmology, investigators led by Eric D. Donnenfeld, M.D., co-chairman, cornea, Nassau Univer- sity Medical Center, East Meadow, N.Y., set out to compare the effects of these two corticosteroids on visual acuity and corneal thickness outcomes after cataract surgery. Investigators launched this multicenter, randomized trial for two reasons. "One reason was to compare the efficacy of two different corticosteroids," Dr. Donnenfeld said. "But even more importantly than that was to look at the idea of pre-dosing corticosteroids before surgery to see if starting patients on steroids then would improve out- comes." In the study, 52 patients who were undergoing uneventful bilat- eral cataract surgery were given a corticosteroid in both eyes. One eye received difluprednate 0.05% and the other received prednisolone acetate 1%. Patients were started on the same dosing regimen beginning Treating continued from page 43 corneas," Dr. Safran said. "Where it will fit in will no doubt be based on strategies that fit the specific clinical situations and the orientation of the surgeon." Dr. Goldberg said, "There is so much more we can do with a kerato- conic cornea. Going forward, I think topographic ablations will also play a role, possibly after CXL. It's an- other argument against implanting a toric lens. Surgeons definitely prefer to correct corneal astigmatism on the cornea, not to correct for it in the lens capsule." The bottom line? "You don't want a lens in the eye and then have to come back and change the cornea later," Dr. Goldberg said. "A toric IOL will reduce astigma- tism but will not address loss of BSCVA by itself. We want to give pa- tients a better quality of vision, and CXL should be able to achieve that," Dr. Trattler said. EW Editors' note: This article discusses off-label uses and procedures that are under investigation in the U.S. Drs. Goldberg, Leach, Myers, Safran, and Wong have no financial interests re- lated to this article. Dr. Trattler has financial interests with Abbott Medical Optics (Santa Ana, Calif.) and CXL- USA. Contact information Goldberg: 732-219-9220 Leach: 866-770-2020 Myers: 847-328-2020 Safran: 609-896-3931 Trattler: 305-598-2020 Wong: 609-921-9437 The left eye of a 78-year-old female patient 1 day after cataract surgery; this eye was treated with difluprednate Source: Eric D. Donnenfeld, M.D. 1 hour before they arrived at the sur- gery center. They got one dose every 15 minutes for an hour while at home and then three more doses every 15 minutes prior to surgery. Following surgery they received three more pulsed doses every 15 minutes. They then received the drops four times a day for one week. This was reduced to twice a day for the following week. Tallying the points When investigators looked at corneal pachymetry on post-op day 1 they found that those in the di- fluprednate group fared significantly better than those on prednisolone. "There was 33 microns less edema in the difluprednate-treated eyes versus the prednisolone-treated eyes," Dr. Donnenfeld said. "There were al- most twice as many patients without edema in the difluprednate group versus the prednisolone group." Of those on difluprednate, 62% re- mained free of edema versus 38% of those on prednisolone. Likewise, on day 1 those who re- ceived difluprednate attained signifi- cantly better uncorrected and best corrected visual acuity. Dr. Donnenfeld attributed this to the marked reduction in edema with the difluprednate. "We think that the corneal endothelium was protective with reduced inflammation," Dr. Donnenfeld said. "This resulted in improved vision and quality of vi- sion in the difluprednate-treated eyes." Longer term, investigators looked at retinal thickness on day 15 and day 30. "There was statistically significantly less edema in the di- fluprednate-treated eyes at 15 days," he said. In addition, investigators con- sidered endothelial cell loss. This was also more promising for those that received difluprednate. "There was a statistically significant differ- ence with less endothelial cell loss in the eyes treated with difluprednate," Dr. Donnenfeld said. Profiling differences Dr. Donnenfeld thinks that some of the success of the difluprednate here is due to the fact that this is a signif- icantly stronger steroid than pred- nisolone acetate. "It had been established in several studies that compared to prednisolone acetate, difluprednate is four to six times stronger," he said. Other differences between the two steroids include the fact that di- fluprednate is a fluorinated corticos- teroid, which Dr. Donnenfeld said increases potency. Also, the type of preparation for each of the two steroids is not the same. "The pred- nisolone acetate is a suspension while the difluprednate is an emul- sion, so it doesn't have to be shaken and it can be stored any way," Dr. Donnenfeld said. "With a suspen- sion you have to shake the drop for it to become effective." Investigators found that compli- cations in the two groups were roughly equivalent. "The number one complication that we were look- ing for was intraocular pressure," Dr. Donnenfeld said. "Of course there was a concern that patients who re- ceived difluprednate had a stronger steroid." However, he pointed out that in the FDA trial there was no statistically significant difference in IOP between the difluprednate and the control group. Likewise, in this study IOP differences between the two groups were not statistically sig- nificant. "The difluprednate patients had a mean pressure of 15.44 mm Hg on day 15, and the prednisolone acetate patients had a 14.58 intraoc- ular pressure," Dr. Donnenfeld said. From a clinical perspective Dr. Donnenfeld sees it as more impor- tant nowadays to choose the right steroid. "The clinical take-home message for me is that there is a new standard of care in ophthalmology, and that is the rapid return of best corrected vision," he said. "Refrac- tive cataract surgery demands a rapid return of quality vision." He stressed that inflammation is the enemy of quality vision. "Our role as ophthalmologists is not just to sup- press inflammation but to eliminate it," Dr. Donnenfeld said. "By pre- treating patients we can eliminate inflammation and the side effects associated with it." In addition, results indicated that the choice of steroid can be im- portant. "Difluprednate is a statisti- cally significant more effective corticosteroid at reducing inflamma- tion because of its potency," Dr. Donnenfeld said. "Because of that it gives patients better refractive out- comes and quality of vision and re- duces complications of cataract surgery such as corneal edema and retinal thickening better than pred- nisolone acetate." EW Editors' note: Dr. Donnenfeld has financial interests with Alcon, Allergan, and Bausch + Lomb (Rochester, N.Y.). Contact information Donnenfeld: 516-446-3525, eddoph@aol.com

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