Isopure® Versus Vivity®: A Prospective, Double-Blind, Randomised Comparison Of Visual Acuity Between Two New Extended Depth-Of-Focus Intraocular Lenses

To assess differences in photopic visual acuity, binocular defocus curves and spectacle independence after bilateral same-day cataract surgery with implantation of Isopure^® or Vivity^®, with mini-monovision.

Vista Alpina Eye Clinic, Visp, Switzerland

This is a double-blind, randomised, prospective study including 136 eyes of 68 patients implanted bilaterally with Isopure^® or Vivity^®, with mini-monovision (-0.5D). The primary endpoint is monocular corrected distance visual acuity (CDVA), measured throughout the entire study (4 to 6 months), along with a full set of far, intermediate (66 cm) and near (40 cm) visual acuity. Binocular distance-corrected defocus curves are obtained after 1 to 2 months. Spectacle independence (PRSIQ) and quality of vision are assessed after 4 to 6 months.

Patient enrolment is complete. The current interim analysis is based on 1-to-2-month data from 98 eyes (visual acuity and defocus curves) and 4-to-6-month data from 31 patients (spectacle independence).

Overall, 99% and 91% of eyes were within ±1.0D and ±0.50D of target refraction. Photopic monocular CDVA was -0.06±0.06 logMAR and +0.01±0.14 logMAR for I^® and V^®, respectively (p = 0.0001).
The uncorrected photopic binocular visual acuity for I^® and V^® was -0.05±0.10 versus +0.04±0.07 logMAR (p = 0.002) at distance, +0.10±0.12 versus +0.10±0.09 logMAR (ns) at intermediate distance and +0.31±0.15 versus +0.28±0.09 logMAR (ns) at near.
The defocus curve was wider for V^® (up to -1.9D) than for I^® (-1.5D), but visual acuity at 0 and -0.5D defocus was significantly better for I^®.
Respectively 88% vs. 85 % of I^® and V^® patients felt comfortable seeing far without glasses, 88% vs. 93% at intermediate distance, and 38% vs. 42 % at near.

According to this interim analysis, all uncorrected and corrected monocular and binocular distance visual acuity values were significantly better for the Isopure^® eyes. Intermediate and near visual acuity was comparable. The defocus curve for Vivity^® was wider, theoretically leading to functional vision up to 53 cm, compared to 67 cm for Isopure^®. This was reflected in slightly higher spectacle independence in the Vivity^® group at intermediate and near distances. The study is nearing completion and the final analysis will be presented at the ESCRS Congress in Amsterdam.