Evaluating The Range Of Vision With A Small Aperture Iol In Patients Previously Treated With A Monofocal Iol In The Other Eye

To evaluate the improvement in extended depth of focus after implanting an IC-8 IOL in the second eye for patients previously implanted with a monofocal or monofocal toric in the first eye.

Twenty-one investigational sites, including private practice and university groups.

In the US IDE clinical trial for the IC-8 IOL, 343 cataract patients in the IC-8 Group received a monofocal or monofocal toric IOL targeted to plano in the first eye, then received an IC-8 small aperture IOL targeted, to -0.75 D, in the second eye.  At 3 months postoperatively, monocular distance corrected defocus curves were assessed and compared.  Uncorrected (UC) monocular visual acuities (VA) for distance (D), intermediate (I) and near (N) were assessed and compared at 6 months postoperatively. Binocular distance corrected defocus curves and binocular UCDVA,  UCIVA, and UCNVA were also assessed at 3 and 6 months postoperatively, respectively (IC-8 Group).

The IC-8 eyes provided 0.91 D greater extended depth of focus compared to the monofocal/monofocal toric eyes. Monocular vision of 0.20 logMAR or better (20/32) was maintained to 1.99 D for the IC-8 eyes. At 6 months, mean logMAR (standard deviation) monocular UCDVA, UCIVA and UCNVA for the IC-8 eyes was 0.128 (0.14), 0.081 (0.19), and 0.206 (0.16), respectively. Mean monocular UCDVA, UCIVA and UCNVA for the monofocal/monofocal toric eyes was 0.034 (0.16), 0.292 (0.18), and 0.483 (0.17). Binocular vision of 0.20 logMAR or better (20/32) was maintained to 2.21 D for the IC-8 group. Mean binocular UCDVA, UCIVA and UCNVA for the IC-8 group was -0.010 (0.11), 0.051 (0.16), and 0.186  (0.14), respectively.

The small aperture IOL provides extended depth of focus for patients who have a monofocal or monofocal toric IOL in one eye and desire a continuous range of vision.