Hydroview with new packaging shows no signs of calcification

In a white paper, Bausch & Lomb describes the performance of the hydrophilic acrylic IOL since a silicone gasket was eliminated.

ByNicole Nader

Removal of a silicone gasket from the packaging of the Bausch & Lomb Hydroview IOL seems to have eliminated calcification problems that were reported with the lens in the late 1990s, according to a white paper released by the manufacturer.

More than 2 years after the IOL’s packaging was modified to remove silicone, there are no new reports of calcification in patients implanted with the repackaged lens. A silicone gasket in the first version of the IOL’s SureFold packaging is thought to be responsible for the calcium deposits found on some IOL surfaces.

“The 2-year mark is an important empiric milestone because of the time frame in which calcium deposits are known to have appeared on affected Hydroview 1.0 … IOLs,” the white paper reports. The Hydroview 1.0 is the designation given to the lens in the SureFold packaging with the silicone gasket.

The white paper, released at the end of July, is entitled “An Issue Resolved — The Hydroview Intraocular Lens: Development, Early Reports of Calcification and Subsequent Actions.” It was authored by two Bausch & Lomb employees, George F. Green, PhD, and Brian Levy, OD, MSc, and David J. Apple, MD, and Liliana Werner, MD, PhD, of the University of Utah’s John A. Moran Eye Center

Beginning in 1999, calcium deposits leading to lens opacification were reported in a small number of patients implanted with the Hydroview at an average of 24 months after implantation. While the percentage of patients affected was small – less than 0.1%, according to the white paper — Bausch & Lomb took action, alerting the surgeons who were using the Hydroview of the reports and halting the U.S. launch of the lens that had been planned for 2000.

Extensive testing of the Hydroview 1.0 IOL led Bausch & Lomb researchers to believe that the presence of silicone on the lens surface, migrating from the silicone gasket, was to blame for calcification on the lens. Following this determination, the IOL packaging was redesigned without the silicone gasket, and the Hydroview IOL was rereleased in 2001. This repackaged, current version of the lens is identified in the white paper as the Hydroview 1.5.

At the 2-year mark, no incidences of calcification have been reported with the Hydroview 1.5, according to the white paper authors.

“We believe that a lens not presenting opacification/calcification within 24 months after surgery will probably not present after that,” Dr. Werner said in a quote reported in the white paper.

Some history

The white paper describes the history of the Hydroview IOL, the reasons suspected to be behind the calcification of the lens, and the postoperative outcomes after the rerelease of the lens.

The Bausch & Lomb Hydroview IOL first entered the market in 1995, packaged in a vial. By 1997, this original version of the Hydroview had been implanted in 189,000 eyes worldwide without significant complications reported, the white paper noted.

The company changed the packaging system of the lens in 1997. With the addition of the SureFold holder/folder, a screw cap sealed with a silicone gasket was added.

In May 1999, Bausch & Lomb first received reports about “clouding” of a small number of the Hydroview IOLs, according to the white paper. There were no reports of clouding of lenses in the original vial packaging, only in the redesigned 1.0 packaging.

“Surgeons reported that they had tried to treat these patients for posterior capsule opacification, but Nd:YAG laser treatment was not effective,” the paper authors noted.

Initial studies found calcium phosphate deposition on the anterior and posterior surfaces of the clouded lenses. The deposits were later found to contain behenic and stearic acids from the patients’ aqueous.

Scientists at Bausch & Lomb began laboratory testing of unimplanted lenses. Using a number of tools for imaging and analysis, they found that Hydroview 1.0 IOLs taken from SureFold packaging demonstrated small areas of silicone deposits. IOLs from the original vial packaging showed no such contaminants.

The silicone gasket, the only differentiating factor between the original Hydroview IOL and the Hydroview 1.0 IOL, came under suspicion early.

Blood-aqueous barrier risk

Analysis of patient data suggested that a compromised blood-retina barrier from diabetic retinopathy or compromised blood-aqueous barrier from previous ocular surgery were risk factors for development of the calcification.

“In these patients, the aqueous is readily exposed to serum molecules, including the fatty acids that are more abundant in patients with an altered lipid metabolism,” the paper authors reported. These exposed serum molecules were attracted to the hydrophobic silicone of the IOL surface, Bausch & Lomb researchers said.

Case-controlled retrospective studies were carried out at locations in Hong Kong, Germany and Sweden to confirm the role of patient risk factors in opacification.

“A risk trend … emerged for any compromise of the blood/aqueous barrier (e.g., previous ocular surgery). In these patients, there is a higher likelihood that fatty acids will be present in the aqueous post-cataract, providing the nidus for calcification if silicone is present on the surface of the lens,” the authors said.

Newest packaging

In 2001, the silicone-free SureFold package for the Hydroview 1.5 was launched worldwide. The Hydroview IOL itself remained identical to previous generations.

“The new packaging retained the ease-of-use of the previous SureFold components, but it was sealed with a gasket made from a perfluoroelastomer,” the white paper authors noted.

Many Hydroview 1.5 lenses have now uneventfully passed the point at which the calcifications were reported in the 1.0 version of the lens, the paper authors note.

For Your Information:

Brian Levy, OD, Msc., vice president, medical and clinical affairs, and George Green, PhD, director of surgical technologies and surface sciences, can be reached at Bausch & Lomb, 1400 N. Goodman St., Rochester, NY 14609; (585) 338-5212; fax: (585) 338-0898; Web site: www.bausch.com.

David J. Apple, MD, can be reached at John A. Moran Eye Center, 5th floor, 50 North Medical Drive, Salt Lake City, UT 84132; (801) 581-8136; fax: (801) 581-3357; e-mail: david.apple@hsc.utah.edu.

Liliana Werner, MD, PhD, can be reached at John A. Moran Eye Center, 5th floor, 50 North Medical Drive, Salt Lake City, UT 84132; (801) 581-8136; fax: (801) 581-3357; e-mail: liliana.werner@hsc.utah.edu. Drs. Apple and Werner have no direct financial interest in the products mentioned in this article, nor are they paid consultants for any companies mentioned.

Bausch & Lomb, makers of the Hydroview 1.5 IOL, can be reached at 1400 N. Goodman St., Rochester, NY 14609; (585) 338-5212; fax: (585) 338-0898; Web site: www.bausch.com.

Reference:

Green FG, Werner L, Apple DJ, Levy B. An Issue Resolved — The Hydroview Intraocular Lens: Development, Early Reports of Calcification and Subsequent Actions. White paper prepared by Bausch & Lomb. July 29, 2003.