September 16, 2002
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Follow-up study documents MDR IOL opacification

NICE, France — Opacification in one particular model of hydrophilic acrylic IOL appears to related to the material used in the lens manufacture, according to a follow-up study presented here.

The SC60B-OUV one-piece foldable acrylic IOL from Medical Developmental Research has previously been reported by Apple and others to be associated with postoperative opacification in a large number of cases. A poster presentation here at the European Society of Cataract and Refractive Surgeons meeting documented the postoperative behavior of the IOL in a number of patients.

Alaji Gadzama Gashau, MD, and associates implanted 155 of the MDR SC60B-OUV lenses in cataract patients at their facility in the United Kingdom. After time revealed that many of the IOLs clouded after implantation, their surgical use was discontinued at the hospital. However, the team continued to document the patterns of opacification in the patients for 4 years. They documented Snellen acuity, capsular changes, patient medical history and medications. Posterior capsulotomy and IOL exchange were performed as needed, and the explanted IOLs were also examined.

It was noted that 67% of the lenses clouded within 8 to 24 months. Between 24 to 48 months, 17 more IOLs opacified. The haptics and the periphery of the optic remained clear in all cases; in 90% of the opacified IOLs , the opacification occurred in the center of the optic.

No cells or deposits were found on the explanted lenses. Probable granules of hydroxyapatite were found well below the IOL surfaces.

According to the poster, the haze did not seem to be associated with viscoelastics, other agents or the IOL’s environment. It is theorized that the IOL material itself is the problem, the authors said.