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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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