EyeWorld Asia-Pacific March 2013 Issue

38 EWAP REFRACTIVE March 2013 A scleral approach to presbyopia by Vanessa Caceres EyeWorld Contributing Writer Procedure in Phase III FDA trial targets plano presbyopes T he expanding options for presbyopic patients in the future may include the placement of scleral implants in the eye. Better known as PresVIEW (Refocus Group, Dallas), this scleral spacing procedure for presbyopes has been around for a while and continues to undergo review and follow up as investigators track patients in the U.S. FDA Phase III stage of PresVIEW’s clinical trial. PresVIEW involves the insertion into the eye of four polymethylmethacrylate implants about the size of a small grain of rice, according to the Refocus website. Surgeons create tunnels for the implants in the scleara with a scleratome, said Karl G. Stonecipher, MD , medical director, TLC Laser Eye Centers, Greensboro, NC, USA. The scleratome used now is a lighter weight model than a previous version. Changes to the scleratome and the procedure itself have halved the time it takes to perform the procedure—from 30 to 40 minutes per eye before to about 20 minutes per eye now, Dr. Stonecipher said. After the implant is inserted, U.S.-based surgeons suture the conjunctiva, while surgeons in Europe are using tissue glue, he said. Patients receive numbing drops and anti-anxiety medication, according to the Refocus website. The patient may have some soreness and inflammation a few days after the procedure, and it takes a couple of weeks for complete healing. The Phase III clinical trial with PresVIEW includes about 330 patients. Patients are plano presbyopes between the ages of 50 and 60 without any need for distance correction; although they may want to improve their reading vision, their best corrected distance visual acuity must be 20/20 or better. Patients’ eyes are operated on three weeks apart. The U.S. trial has reached the maximum allowed enrollment, and therefore is no longer enrolling patients; instead, investigators around the U.S. are focusing on the collection of two years of follow- up data, said Lance Kugler, MD , Kugler Vision, and University of Nebraska Medical Center, Omaha, Neb., USA. The trial should be complete by July 2014, according to ClinicalTrials.gov. So how’s it working? What is surprising to investigators is how patients in the trial are finding increased visual improvement over time, instead of great visual improvement right away that might fade with time. “It’s as if to say, ‘I’m giving you the gym, you build that muscle up and work it out,’” Dr. Stonecipher said, noting that 52 patients have participated at his practice. “If you look at our patients after six months, you see more of an effect than at three months. If you look at them at one year, there’s a better effect than at six months. The procedure seems to continue to improve their ability to see with time,” Dr. Kugler said. “Of the patients we’ve done, no one has worsened, and most people have improved.” Some of Dr. Kugler’s 30 patients no longer need reading glasses; others still use them for some tasks, he said. “Patients have improved reading vision from the procedure,” Scleral spacing procedure implant Scleral spacing procedure implant position behind eyelids Source (all): Karl G. Stonecipher, MD Scleral spacing procedure implant procedure steps said Brian S. Boxer Wachler, MD , director, Boxer Wachler Vision Institute, Beverly Hills. Dr. Boxer Wachler has been involved with PresVIEW since its Phase I trials; in Phase III, he has performed the procedure in 13 patients/26 eyes. Although the results have been