Phakic IOL: 10-Year Safety Data

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During the 10 years after phakic intraocular lens (PIOL) implantation, visually significant cataracts developed in 18.3% of the high myopes implanted with the device, a long-term outcomes study has found.¹

The Swiss researchers analyzed the refractive and safety outcomes from 133 consecutive surgeries (1998-2004) in which the V4 version of the Visian ICL (Implantable Collamer Lens; Staar Surgical) was implanted. This lens is the only sulcus-supported PIOL approved by the U.S. Food and Drug Administration.

What to watch for. Although the PIOL’s long-term safety and refractive results were generally good, with stable endothelial cell counts, the data also showed that patients should be warned about 2 potential complications: cataract and ocular hypertension, the authors reported. The analysis found that after 10 years of follow-up:

• Lens opacities were present in 54.8% of the eyes (95% CI, 44.7%-63.0%).
• Phacoemulsification to remove visually significant cataracts was required in 18.3% of the eyes (95% CI, 10.1%-25.8%). This compared to 4.9% at year 5.
• Although no cases of elevated intraocular pressure had been observed at the 5-year follow-up, at 10 years, 12 eyes (12.9%; 95% CI, 5.6%-19.6%) had developed ocular hypertension requiring medication.

Long-term follow-up required. “Phakic lenses are the best refractive surgical option today to correct high ametropia. But our study shows that these patients must have careful follow-up forever,” said coauthor François Majo, MD, PhD, professor and head of refractive surgery at the Jules-Gonin Eye Hospital at the University of Lausanne.

Dr. Majo said the study’s findings will enable refractive surgeons to better inform PIOL candidates about the potential risks. “This is important information to give to the patient before the surgery. But, surprisingly, in my experience it does not change their decision,” he said.

—Linda Roach

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1 Guber I et al. JAMA Ophthalmol. Published online March 3, 2016. doi:10.1001/jamaophthalmol.2016.0078.

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Relevant financial disclosures: Dr. Majo—None.

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