Use of a toric implantable contact lens (Visian Toric ICL, STAAR Surgical) should be considered as a viable alternative to customized LASIK procedures in patients with myopia as low as ?3 D, said Paul J. Harton Jr., MD, PharmD, of the Harbin Clinic Eye Center, Rome, GA.
Use of a toric implantable contact lens (Visian Toric ICL, STAAR Surgical) should be considered as a viable alternative to customized LASIK procedures in patients with myopia as low as –3 D, said Paul J. Harton Jr., MD, PharmD, of the Harbin Clinic Eye Center, Rome, GA.
"The toric [lens] should be seriously considered not only as a surgery of choice for patients with high myopia or patients who are not candidates for LASIK, but they should also be considered as an alternative to LASIK in many instances," he said.
Dr. Harton reported on a retrospective study using comparative information about the lens from the manufacturer's pre-market approval application to the FDA and summary of safety and effectiveness data about two wavefront platforms (STAR S4/CustomVue, Advanced Medical Optics; LADARVision 4000/CustomCornea, Alcon Laboratories) from the LASIK approvals for the systems.
"Now with the toric [lens] in front of the FDA, we need to start looking at wavefront comparisons," he said.
Patients were divided into two refractive groups: 3 to 7 D and 7 to 11 D of myopia, with astigmatism.
Results showed that a larger percentage of patients in whom the lens had been implanted experienced 20/20 or better uncorrected visual acuity than those who had undergone customized LASIK, although the difference was not statistically significant. Also, more patients in the lens group had postoperative vision of 20/40 or better, but the difference was not statistically significant.
"It still does raise some eyebrows about how good [customized LASIK] is in this range," Dr. Harton said.
Also, more of the patients in both groups receiving the lens experienced predictability of ±0.50 D and ±1 D compared with patients who had undergone customized LASIK ablation procedures.
"Not that they weren't all good [regarding predictability]. That's not the point of the talk," Dr. Harton said. "The point of the talk is that, at least numerically, [the lenses] are close or maybe even better than the lasers."
BSCVA was worse postoperatively compared with preoperatively in 3% of lens patients; the rate for the lasers was approximately 8%.
"When you look at who improved two or more lines of vision with the [lens], there was a statistically significant difference in the number of people who did that versus the laser," Dr. Harton said. Twenty percent of lens patients experienced such an improvement, he added, versus 11% who underwent the CustomVue procedure and 2% who underwent the CustomCornea procedure.
UVCA improved postoperatively over preoperative BSCVA levels in 48% of lens patients, versus 23% of patients undergoing the CustomCornea procedure. The difference was statistically significant, Dr. Harton said. Data for the CustomVue system were not available.
Comparing preoperative BSCVA and postoperative UCVA "is a nice marker, because if you're making people better uncorrected than they were corrected prior to surgery, then you tend to have very happy patients," Dr. Harton said.