Eyeworld

EW NEWS & OPINION 14 Results show SIM-LASIK with the AcuFocus KAMRA inlay to be a promising procedure for presbyopia patients with ametropia W hile the AcuFocus (Irvine, Calif.) KAMRA intracorneal inlay is undergoing clinical trials for FDA ap- proval to treat presbyopia patients, surgeons abroad have already started to combine the inlay implantation surgery with LASIK. The procedure, called SIM- LASIK, allows surgeons to optimize refractive outcomes by setting post- op refractive targets. Minoru Tomita, M.D., executive director, Shinagawa LASIK Center, Tokyo, whose practice has performed 1,000 SIM-LASIK procedures since June 2009, reported positive results. The technology The KAMRA inlay has an overall di- ameter of 3.8 mm, which is smaller than a contact lens. It has a 1.6 mm center aperture, which is a small opening in the center that creates a pinhole effect. The device is 5 mi- crons thick, made of polyvinylidene fluoride and carbon, and it has 8,400 random holes for oxygen and nutrition flow. The AcuFocus corneal inlay is designed to improve depth of focus, allowing the eye to see near and intermediate objects more clearly, Dr. Tomita said. Surgical technique A 200 micron corneal flap is created in the non-dominant eye. Using the Femto LDV (Zeimer Ophthalmic Sys- tems, Port, Switzerland), the flap thickness can be reproduced almost exactly every time, Dr. Tomita said. Excimer laser ablation is then per- formed and the KAMRA inlay is po- sitioned and centered under the flap using the AcuTarget system, which guides surgeons in the proper place- ment of the device. The entire pro- cedure usually takes 10 minutes, Dr. Tomita said. Results Presenting data on 439 eyes that un- derwent SIM-LASIK at the Shina- gawa LASIK Center, Dr. Tomita said that uncorrected distance visual acu- ity saw a mean improvement of eight lines from 20/125 pre-op to 20/20 at 6 months post-op. This was a statistically significant difference, Dr. Tomita said. In addition, mean uncorrected near visual acuity im- proved four lines from J9 pre-op to J2 at 6 months post-op. Follow-up is currently at 14 months and results have been stable, Dr. Tomita reported. Although there have not been any complications during surgery, post-op care found that some pa- tients suffered from dry eye, as with regular LASIK patients. However, with dry eye treatment, patients' symptoms improved, Dr. Tomita said. The surgery is easy for refractive surgeons because it only involves the additional implanting of the inlay after excimer laser ablation and otherwise follows the same technique as regular LASIK, Dr. Tomita said. "It's an easy but effec- tive treatment," he said. Dr. Tomita pointed out that get- ting good centration of the KAMRA inlay is rather difficult but very im- portant. Therefore, surgeons new to the technique will have a bit of a learning curve before they are able to center the inlay well. The AcuTar- get machine developed by AcuFocus to guide surgeons in centration is helpful, Dr. Tomita said. Dr. Tomita said that the AcuFo- cus KAMRA's pinhole center is an important part of the procedure's success. "Because its center is a pin- hole, there's no risk of causing opac- ities." In the 1,000 cases done at Shi- nagawa LASIK Center, 92% of pa- tients are spectacle independent and very happy, Dr. Tomita said. He con- cluded that SIM-LASIK is an effective treatment in a high volume practice, and patients have shown improve- ments in both near and distance vi- sual acuity. Outside of Japan, the simultane- ous bilateral LASIK and unilateral KAMRA inlay implantation tech- nique has shown equal promise. At the XXVII European Society of Cataract and Refractive Surgeons meeting in Barcelona, Donald T.H. Tan, F.R.C.Ophth., director, Singa- pore National Eye Center, Singapore, reported initial results of patients who underwent the procedure. One week post-op, patients had a visual acuity near J3 and improved to J2 by 1 month, he said. Although long- term data is needed, Dr. Tan said early reports indicate highly satisfied patients, and the lens shows promise of becoming the best means of pres- byopia correction currently avail- able. When used in combination with refractive surgery, Dr. Tan said the standard contraindications of keratoconus or dry eye remain. EW Editors' note: Dr. Tomita has no finan- cial interests related to his comments. Contact information Tomita: +81.3.5221.2207, tomita@ shinagawa.com February 2011 by Enette Ngoei EyeWorld Contributing Editor Optimizing refractive outcomes in presbyopia patients The AcuFocus KAMRA inlay for the treatment of presbyopia Source: Perry S. Binder, M.D.

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