Production, sale of anterior chamber lens suspended

March 15, 2007

Monza, Italy-Correction of very high myopia, i.e., above –9 D, remains a controversial topic. New designs of phakic IOLs spurred great interest in the past 5 years. Long-term results are becoming available, and some interesting conclusions can be drawn, said Matteo Piovella, MD, who reported on his 4-year results with one of these lenses at the XXIV Congress of the European Society of Cataract and Refractive Surgeons in London. One anterior chamber phakic IOL (Vivarte, IOLTECH SA, La Rochelle, France) appeared to offer promising results.

However, safety concerns pertaining to endothelial cell loss have surfaced, requiring follow-up every 6 months after implantation. In some cases, patients have required explantation of the anterior chamber lens.

In light of these concerns, the company voluntarily suspended production and marketing of the lens in December, explained Dr. Piovella, director of Centro de Microchirurgia Ambulatoriale, Monza, Italy.

This anterior chamber lens is a foldable, angle-supported implant with a 5.5-mm soft optic made of hydrophilic acrylic and rigid haptic of polymethylmethacrylate. Soft feet, also of hydrophilic acrylic, are attached to the haptic and come in contact with the anterior chamber angle. The lens was available in three sizes for an overall diameter of 12, 12.5, or 13 mm. The lens was designed to correct high myopia in the range of –7 to –25 D in 0.5-D increments.

The difficulties that Dr. Piovella had with the lens were pupil ovalization and ECC loss, which required explantation in four cases, he said. The database was evaluated with the support of Dr. Fabrizio Camesasca, of the ophthalmology department of the Istituto Clinico Humanitas, Milano, Italy.

Patient selection criteria