EyeWorld Asia-Pacific June 2018 issue

June 2018 EWAP REFRACTIVE 49 Light Adjustable Lens implant technology by Michelle Stephenson EyeWorld Contributing Writer Light Adjustable Lens Source: Roy Freeman A newly approved lens that can be adjusted postopera- tively I n November 2017, the U.S. Food and Drug Administration (FDA) approved the RxSight (Aliso Viejo, California) Light Adjustable Lens and the Light Delivery Device (LDD) for patients with 0.75 D or more of pre-existing astigmatism. This is the first FDA- approved lens that can be adjusted postoperatively to improve uncor- rected visual acuity. FDA approval was based on results of a U.S. randomized, pivotal study comparing the Light Adjust- able Lens to a commercially avail- able monofocal lens in 600 patients with pre-existing astigmatism at 17 investigational sites. Patients receiving the Light Adjustable Lens followed by light treatment with the LDD achieved uncorrected visual acuity of 20/20 or better at 6 months postoperatively at approxi- mately twice the rate of the patients who received a monofocal lens. Additionally, 91.8% of Light Adjustable Lens patients achieved a result that was within 0.50 D of target manifest refraction spherical equivalent, which is similar to the refractive accuracy seen in recent LASIK studies. All of the study eyes had a best corrected visual acuity of 20/40 or better at the 6-month postoperative visit. The approved device allows correction of up to 2 D of postoperative sphere and/or –0.75 to –2 D of residual postopera- tive refractive cylinder. “We were thrilled to receive FDA approval and are grateful to all those who were involved in this effort,” said Roy Freeman , senior director of marketing for RxSight. “We are currently working with the FDA on a post-approval process, as well as building the infrastructure to support a global launch. We will make an announcement sometime this year as far as launch timing.” According to Mr. Freeman, the adjustment is done with UV light, and while there are a lot of light treatment profiles that can be performed with the LDD, RxSight is currently approved for correcting sphere and cylinder. “This is done Ronald YEOH, FRCS, FRCOphth, DO, FAMS Adj. Associate Professor , Duke-NUS Grad Med School Singapore National Eye Centre Consultant Eye Surgeon & Medical Director Eye & Retina Surgeons #13-03 Camden Medical Centre One Orchard Boulevard Singapore 248649 Tel. no. +65 67382000 ry@ers.clinic T he Light Adjustable Lens has been around for many years and it is exciting news that it is now in clinical application and delivering good results. That it is FDA approved, at least for postoperative astigmatism of >0.75 D, is further support of its potential benefits and safety. The ability to easily and safely adjust the post-cataract surgery refractive outcome is desired by all cataract surgeons and I anticipate significant interest in this new technology. “ The ability to easily and safely adjust the post- cataract surgery refractive outcome is desired by all cataract surgeons and I anticipate significant interest in this new technology. ” - Ronald Yeoh, FRCS, FRCOphth, DO, FAMS However, as with all new technologies that come to market, there will be uncertainties and many questions to be asked. How easy is the technique for the average cataract surgeon? Can retreatments be done? How bulky is it? How do we incorporate its use in our clinic flow? What are the long-term results and stability of the treated lens refraction? What as yet unrealized complications might there be? Finally, as with all new modalities of treatment, cost is always a concern; cost of equipment and recurrent cost of the implants and click fees. Editors’ note: Dr. Yeoh declared no relevant financial interests. Views from Asia-Pacific continued on page 50