BSCVA maintained over 5 years with ICL, according to multicenter study

Best spectacle-corrected visual acuity (BSCVA) was maintained over a 5-year follow-up of clinical outcomes in a 15-site FDA study of a proprietary phakic lens (Visian ICL, STAAR Surgical), according to John A. Vukich, MD, who practices with the Dean Health System, Madison, WI.

The only complication reported was clinically significant anterior subcapsular cataract in seven of 526 patients (1.3%). After cataract extraction, excellent visual results were seen, he said. BSCVA averaged 1 line of improvement over pre-implantation levels. No cataracts formed in patients with pre-existing myopia >12 D.

Previously, 3-year follow-up data on 526 patients in whom the lens had been implanted were reported. Now, 384 patients have been followed for a total of more than 4 years, and 311 have been followed for a total of more than 5 years. The average preoperative myopia was –10.06 D.

In eyes targeted for emmetropia with a preoperative BSCVA of 20/20 or better, 5-year postoperative uncorrected visual acuity was 20/20 or better in 50.9% of patients and 20/40 or better in 91.7%.

"There is a little bit of additional myopic drift over time," Dr. Vukich said. "Compared with the 1-year data, we did lose a few patients in terms of the ability to see equal or better than their preoperative BSCVA, but nevertheless, over 50% were still able to achieve that milestone."

Patient satisfaction with the implant after 4 years "comes in around 100%," Dr. Vukich said. The 5-year follow-up did not include a patient satisfaction survey, he added, but the 6-year follow-up will do so.

"Of course, it's hard to make everybody happy all the time, but it's certainly been consistent at 1, 2, 3, and 4 years," he said. "Patients were very pleased with the quality of acuity, and that remains the same."

Long-term safety is still a concern with all phakic IOLs, Dr. Vukich said.

"I don't think anyone doubts the ability of the lens to correct a refractive error," he said. "We're confident with that. But safety remains an issue."