Visual, clinical and quality of life outcomes of a new multifocal IOL with optimized diffractive grating: a non-randomized clinical trial.

Abstract

Background: Multifocal intraocular lenses (IOLs) are designed to reduce dependence on spectacles by providing multiple focal points. However, they are associated with photic phenomena such as halos and glare, and may reduce contrast sensitivity. The BIOS Trifocal is a single-piece acrylic diffractive IOL with a closed-loop haptic design, optimized for centration and stability. It features an aspheric, aberration-neutral surface and a precisely engineered diffraction grating for effective energy distribution across multiple distances. This study aims to evaluate the visual, clinical, and quality of life outcomes of the BIOS Trifocal IOL for treatment of cataract and presbyopia.

Methods: Participants who met the inclusion criteria underwent implantation of the BIOS Trifocal IOL and were assessed at 30 and 90 days post-surgery. The evaluations included measurements of patient-reported outcomes using the NEI-VFQ 25 at postoperative day 30 and uncorrected and corrected distance visual acuity and defocus curves at postoperative day 90. Additionally, intraoperative and postoperative complications were documented. Visual acuity assessments were performed under photopic conditions, with a range of defocus from + 1.5 D to -3.0 D.

Results: Significant improvements were observed in uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and near visual acuity (UNVA) at both 30 and 90 days post-surgery (p < 0.001). The defocus curve demonstrated functional vision from + 1.5 D to -3.0 D, supporting the lens's efficacy for near, intermediate, and far distances. Quality of life, as assessed by the NEI-VFQ 25, showed marked improvement across all domains (p < 0.05), with no significant complications directly attributable to the IOL.

Conclusions: The BIOS Trifocal IOL presented satisfactory effectivity in the treatment of cataract and presbyopia, providing functional vision across near, intermediate and far distances and maintaining good patient satisfaction.

Trial registration: This trial was registered at the ReBEC (Registro Brasileiro de Ensaios Clínicos - Brazilian Registry of Clinical Trials)database under the registration code RBR-772s6y at April 6th, 2020.