iSpheric IOL makes US debut

November 1, 2008

The iSpheric Model YA-60BB intraocular lens (IOL) (Hoya) has received FDA market approval. The lens has been available in Europe since 2003.

The iSpheric Model YA-60BB intraocular lens (IOL) (Hoya) has received FDA market approval. The lens has been available in Europe since 2003.

A clinical trial assessed the safety and efficacy of the iSpheric IOL: 446 of 617 enrolled eyes completed follow-up period of 12-months. Best corrected visual acuity (BCVA) of ≥20/40 was achieved by 98.7% of eyes; of ≥20/20, by 52.8%. The postoperative incidence of the most common adverse event at final follow-up, persistent macular oedema, was 0.8%; of all eyes implanted with the lens, nine (1.5%) required further surgical intervention and 57 (9.3%) required treatment for Posterior Capsule Opacification (PCO). 

The monofocal posterior chamber lens is indicated for primary implantation in the capsular bag of aphakic eyes. The lens, which is 12.5 mm in diameter, has a foldable 6.0 mm acrylic optic designed to absorb ultraviolet and blue light. The PMMA haptics are angled at 5º.

The lens is available for 6.0 D–30.0 D of correction, in increments of 0.5 D.