Recall shows high prevalence of opacification in diabetic patients with hydrophilic acrylic IOL

J Cataract Refract Surg. 2011;37(4):655-659.

A hydrophilic acrylic IOL was associated with opacification in patients with diabetes mellitus, a study found.

Investigators conducted a recall of all patients in a Malaysian hospital who received the implant in 2005 and 2006. The recall stemmed from three reported cases of opacity in the AcriFlex 50CSE IOL (Acrimed) about 3 years after implantation.

"The IOL opacification was caused by deposition of calcium and phosphate on the IOL surface and intralenticularly near the anterior surface of the optics," the study authors said. "Although the pathophysiology of this complication is unknown, we found a strong association with diabetes mellitus."

The cross-sectional study included 239 eyes of 239 patients who had received the IOL and were recalled. Mean patient age was 64.8 years.

Opaque IOLs were explanted and underwent scanning electron microscopy and energy-dispersive X-ray spectroscopy.

Investigators identified IOL opacification in 14 eyes of 13 patients (5.4%). Seven opaque IOLs required explantation. The mean interval between cataract surgery and opacification was 28.7 months. Associations between age, sex, ethnicity and IOL opacification were not correlated.

Results showed that nine patients with IOL opacification (69.2%) and 83 patients with clear IOLs (36.7%) had diabetes mellitus. Statistical analysis showed a statistically significant association between diabetes and IOL opacification (P = .019), the authors said.

Patients who received the IOL will be monitored for at least 5 years so that emerging opacification may be identified, the authors said.