BBI Contributing Editor
Recent clinical results on American patients make officials at Surgilight (Orlando, Florida) very optimistic about the company's Laser Presbyopia Reversal (LAPR) technology and its chance for FDA approval within three years.
Ten patients in the U.S. had favorable results after treatment with Surgilight's OptiVision solid-state laser and its unique hand-held probe. This success follows positive results for 300 eyes internationally. In 11 countries, a total of 300 eyes from patients aged 42 to 72 received LAPR. More than 90% were able to read without spectacles post-operatively, with an average accommodation gain of 1.9 diopters. Even more important, at two years the average regression from this gain was only 0.25 diopters.
The 10 U.S. patients were treated in New York and Las Vegas, Nevada. Their accommodation increased from an average of about 2.4 diopters pre-operatively to 4.0 diopters at four weeks post-operatively. All 10 had visual acuities of 20/30 or better following surgery. Surgilight is now waiting for the FDA to increase the study to 50 patients.
The laser has a 3-micron wavelength for tissue ablation, at a repetition rate that is adjustable from 1 to 30 Hz. The OptiVision was set at 20 mJ and 20Hz for LAPR. It differs from other refractive lasers due to its patented conical contact tip, which actually touches the sclera to perform the ablation. Surgilight CEO Collette Cozean, PhD, explained that the sclera is ablated about 600 microns, or through 80% of its depth. Surgeons incise until they see the dark blue color of the choroids. The eight incisions are each 4 1/2 mm long and the cuts start just past the limbus, she noted. The goal is to expand the globe in the area of the ciliary body. The conjuctiva above the incision area is removed prior to scleral ablation and closed afterwards. The procedure is performed under topical anesthesia.
Cozean said that regression has been much less than in LASIK surgery. "The animal study demonstrated that fibrin-like flexible tissue fills the incisions permanently expanding the circumferential diameter," she said. Some patients have had the procedure re-touched by opening up the incision later or adding another incision. She said that FDA approval would take two to three years, if all goes well. Approval in Europe and Mexico should occur within six months, and in Canada within one to two years, she added.
Ten patients were treated in the U.S. as a necessary step in achieving FDA approval to begin large-scale studies. Eight were operated upon at Siems Advanced Lasik Center (Las Vegas, Nevada) and the remainder at Cornell Weill Medical Center (New York). Preoperative mean uncorrected visual acuity was 20/69 for both eyes. Immediately after surgery, it was 20/38 OD and 20/42 OS. The researchers found "marked improvement" at one day post-operatively in nine of the 10 patients. At two months, all patients were J2 or better.
"I'm really optimistic because the results with the first patients were good. Of course, we have to see what happens in the future," said Sandra Belmont, MD, director of corneal services at Cornell Weill. At six weeks post-operatively, her patients had 20/25 and 20/20 vision. "The procedure is technically easy. A general ophthalmologist could do it," she said.
John Siems, MD, director of the Las Vegas center that treated eight patients, said that using the laser was "a very controlled situation." Siems said that he never felt worried about incising too deeply. He said there is "some skill" to learning the procedure, which takes longer than LASIK, at 20 to 25 minutes. Belmont said that originally, the hand-held probe's tip was used while close to, but not touching, the sclera. But holding it directly on the sclera provides greater control, she said.
In the U.S., the patients' IOP tended to be higher just following surgery and lower a week after surgery although their pressure recovered by four weeks. The international patients had lower IOPs just following surgery and at all times thereafter. Oddly, the amount of accommodation gained by U.S. patients did not correlate with greater visual acuity. Five patients whose accommodation changed more than two diopters had no better acuity than two who gained only one diopter. All visual acuity measurements were excellent.
Belmont said she was happy with the cosmetic results as well. "At one month, it is barely detectable," she said.
Siems said that the procedure, if approved in this country, would be unlikely to reach the bargain prices that LASIK has. Belmont said she could imagine LAPR being priced similarly to LASIK, although she noted that LASIK prices vary wildly.
Surgilight said it hopes that the data it submitted to the FDA on these 10 patients will convince the FDA to allow a larger study. Eight sites treating approximately 50 patients each are planned, including the centers of Siems and Belmont.
Cozean noted the huge potential market for LAPR, since everyone gets presbyopic "if they live long enough." OptiVision is a self-calibrating, solid-state laser system. It measures 22.5" x 20" x 16" and weighs 22.6 kg.