Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery.

Purpose: To evaluate the clinical acceptability of monocular implantation of the small-aperture (IC-8) intraocular lens (IOL) in 1 eye and an aspheric monofocal IOL in the fellow eye of bilateral cataract patients over 6 months postoperatively.

Setting: Twelve clinics in Austria, Belgium, Germany, Italy, Spain, and Norway.

Design: Prospective case series.

Methods: The visual acuity, depth of focus, contrast sensitivity, patient satisfaction, visual symptoms, and adverse events were assessed in patients who had bilateral cataract surgery followed by implantation of the small-aperture IOL in 1 eye and an aspheric monofocal IOL in the fellow eye. Uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuities were reported in Snellen notation.

Results: The study comprised 105 patients. At 6 months, the UDVA, UIVA, and UNVA in eyes with the small-aperture IOL were 20/23, 20/24, and 20/30, respectively. Ninety-nine percent, 95%, and 79% of patients achieved 20/32 or better binocular UDVA, UIVA, and UNVA, respectively. Ninety-three patients (95.9%) reported they would have the procedure again versus 4 patients (4.1%) who reported they would not have the procedure again. In eyes with the small-aperture IOL, the target-corrected defocus curve measured with 0.75 diopter (D) of myopia extended the range of functional near vision by an additional diopter without loss of distance vision compared with the distance-corrected defocus curves. The mean UIVA and UNVA remained at 20/25 and 20/32, respectively, for up to 1.5 D of residual astigmatism in eyes with the small-aperture IOL.

Conclusion: The small-aperture IOL showed excellent visual performance, safety, patient satisfaction, and tolerance to residual astigmatism 6 months after implantation.