Prospective clinical study of a new intraocular lens with extended depth of focus: ISOPURE, 1 year follow‐up

Abstract

Aims/Purpose: Monofocal lenses are currently the most frequently implanted intraocular lenses (IOL). New implants with enhanced depth of focus (EDOF) could improve intermediate and near visions with uncompromised far visual acuity and limited dysphotopsia. The objective of this study is to compare Group 1 – a bilateral implantation of an EDOF IOL‐ Isopure® versus Group 2 – a bilateral monofocal IOL – Micropure® – (BVI, Belgium).Methods: Eligible patients with bilateral cataracts were randomly assigned to two groups. Monocular, binocular, corrected, uncorrected, near, intermediate and far visions were measured before, 1 month and 1 year after surgery using ETDRS charts. A pre‐ and post‐operative questionnaire was realized to assess the impact of their vision on daily routine.Results: One year after the surgery near median visions were respectively 0.22 ± 0.18 and 0.44 ± 0.10 LogMar (p‐value = 0.0515) while intermediate visions were −0.02 ± 0.12 and 0.14 ± 0.07 LogMar (p‐value = 0.0595). No significant difference was demonstrated in the binocular distance visual acuities, respectively −0.09 ± 0.14 and −0.12 ± 0.15 (p‐value = 1.00). The study revealed no significant difference regarding sensitivity of contrast and the defocus curve had a larger curve plate of good visual acuity in the Isopure® group. The questionnaire's analysis showed no significant difference between the groups.Conclusions: Although no significant difference was demonstrated, this study suggests that with a larger patient sample, the Isopure® implant may provide better near and intermediate visual activity, since our p‐values are close to 0.05, with the same distance vision and no deterioration of the contrast sensitivity. This implant provides a daily visual comfort and the patients reported a better satisfaction, fewer dysphotopsias, less difficulties with daily activities and less dependence on their glasses.