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

The study aims to evaluate visual acuity, binocular defocus curves, contrast sensitivity, and patient-reported outcomes in patients undergoing bilateral same-day cataract surgery with either Isopure® or Eyhance® lenses, adopting a mini-monovision approach. This is a double-blind, randomized, prospective study with a follow-up period of 4 to 6 months.

Single-center study at Vista Alpina Eye Clinic, Visp, Switzerland.

In a double-blind, randomized, prospective design 136 eyes of 68 patients are implanted bilaterally with Isopure® or Eyhance®, with mini-monovision (-0.5D). The primary endpoint is monocular corrected distance visual acuity (CDVA), measured over 4-6 months, along with a full set of far, intermediate (66 cm) and near (40 cm) visual acuities. Binocular distance-corrected defocus curves are documented after 1-2 months. Photopic and mesopic contrast sensitivity (CSV-100) are assessed at 4-6 months. Patient-reported outcomes, including spectacle independence (PRSIQ), photic phenomena (NEI RQL-42), and satisfaction (CatQuest 9SF), are evaluated at 1-2 and 4-6 months. This interim analysis includes data from 42 eyes of 21 patients.

Overall 100% and 90.5% of eyes were within ±1.0D and ±0.50D of target refraction (p= 0.36 between groups). Photopic monocular CDVA averaged -0.06±0.06 logMAR for Isopure® and -0.04±0.10 logMAR for Eyhance® (p = 0.66). Uncorrected photopic binocular visual acuity for Isopure® and Eyhance® was +0.01±0.08 vs. +0.00±0.10 logMAR (p = 0.50) at distance, +0.13±0.13 vs. +0.03±0.08 logMAR (p=0.056) at intermediate and +0.37±0.18 vs. +0.21±0.11 logMAR (p=0.02) at near. Eyhance® demonstrated a broader defocus curve than Isopure® (2.85D vs. 2.45D at logMAR 0.2), and superior visual acuity at -2.0D and -2.5D defocus. Overall, 76% of patients experienced no glare, and 95% reported being free of halos and starbursts, with no difference between the groups.

Interim findings indicate comparable (un)corrected mono- and binocular distance visual acuities for both lenses. Eyhance® exhibited a broader binocular distance-corrected defocus curve, suggesting functional vision up to 54 cm, compared to 69 cm with Isopure®. This was reflected in superior uncorrected binocular visual acuity at intermediate and near distances for the Eyhance® group. Patient recruitment is nearing completion with a pre-final analysis to be presented at the 2024 ESCRS Congress. This study is part of a broader clinical trial program that utilizes a uniform double-blind study design to compare various EDOF lenses. The results of this trial will be juxtaposed with those from a previous study involving Vivity® and Isopure®.