Investigational phakic IOL for high myopia promising

The first single-piece, foldable lens of this brand had a 5.5-mm optic, an overall length of 12.5 to 13.5 mm, and a dioptric range of –8 to –16.5 D and was implanted by Michael C. Knorz, MD, professor of ophthalmology, University Medical Center Mannheim, Mannheim, Germany. He presented the long-term clinical results from the phase I European clinical trial of the lens after 5 years.

Dr. Knorz and Joseph Colin, MD, professor and chairman, CHU de Bordeaux, Hôpital Pellegrin, Bordeaux, France, were the two investigators in the open-label, single-arm, dual-center phase I European trial of the phakic IOL. The lens was implanted unilaterally in 10 patients using a specific IOL delivery system (Monarch I, Alcon Laboratories). Nine of 10 patients were followed for 5 years and one patient was lost to follow-up.

Patients selected for inclusion in the phase I European trial had to be aged at least 21 years, have stable myopia greater than or equal to 8 D, an anterior depth of 3.0 mm or greater, and less than 2 D of preoperative astigmatism. They could not have a mesopic pupil greater than 6.0 mm and endothelial cell density had to equal or exceed 2,500 cells/mm² .

The mean manifest refractive spherical equivalent (MRSE) for the patient population was –11.35 D preoperatively, improved to –0.5 D at 1 day postop, and was –0.79 D at 6 months postop, –0.86 at 1 year postop, and –0.88 D at 5 years, Dr. Knorz noted. At 5 years postoperatively, the refractive predictability was met for the percentage of eyes within ±0.5 D of intended MRSE, 57%, and was slightly lower for the percentage of eyes within ±1.0 D of intended MRSE, 71%. The FDA guidance criterion was 50% within ±0.5 D of intended MRSE and was 75% within ±1 D of intended MRSE. Although, statistically, this is not too meaningful for nine eyes, Dr. Knorz noted.

Uncorrected visual acuity (UCVA) at 5 years was 20/20 or better in 55.6% of eyes and 20/40 or better in 88.9% of eyes. Best-corrected visual acuity during this period was excellent, with 66.7% of the eyes achieving 20/20 or better and 100% of the eyes achieving 20/25 or better.