Global Consolidated Outcomes From Clinical Trials Of A Trifocal Iol With A 3.2 Mm Diffractive Zone

Published 2025 - 43rd Congress of the ESCRS

Reference: FP09.03 | Type: Free paper | DOI: 10.82333/jhd8-x693

Authors: Klemens Paul Kaiser* ¹ , Jakob Wend ¹ , Petra Davidova ¹ , Tyll Jandewerth ¹ , Zubeida H. Omerovic ¹ , Eva Hemkeppler ¹ , Christoph Lwowski ¹ , Myriam Böhm ¹ , Thomas Kohnen ¹

¹Department of Ophthalmology,Goethe-University Frankfurt,Frankfurt,Germany

Purpose

To assess the safety and effectiveness of a Gaussian trifocal intraocular lens (IOL) with a truncated, non-apodized 3.2 mm diffractive zone from prospective clinical trials conducted across various ethnic groups.

Setting

The consolidated results of three prospective, manufacturer-sponsored clinical trials have been compiled to compare clinical outcomes and subjective patient responses between 4 to 6 months and 12 months post-cataract surgery. The study included 526 subjects across 41 worldwide investigational sites located in Germany, Spain, France, Belgium, Austria, Thailand, Singapore, and Japan.

Methods

A total of 526 test subjects were implanted with trifocal IOLs. The duration of follow-up varied from 4 to 6 months up to 12 months after lens extraction, with both non-toric and toric IOLs from the same manufacturer. Binocular defocus curve visual acuities (VA), patient-reported outcomes for visual disturbances (McAlinden QoV Questionnaire), and adverse events were assessed in all trials.

Results

At the 4 to 6-month exam, 205 subjects had binocular defocus testing. The mean ± standard deviation (STD) distance and near defocus VA were -0.09 ± 0.07 logMAR and 0.04 ± 0.10 to 0.03 ± 0.09 logMAR at -2.5 to -3.0 D (40 to 33 cm), respectively. Defocus mean VAs were better than 0.1 logMAR across the visual range.

The percentages of subjects who reported never wearing glasses: 88.2% for near, 95.2% for intermediate, and 95.4% for far vision.

The mean visual disturbance scores (0 – 100) were 36.3 (Frequency), 31.4 (Severity), and 29.4 (Degree of Bother).

The incidence of adverse events and explantation rates are comparable with those reported in leading publications for a major trifocal competitor.

Conclusions

Trifocal subjects experienced a full range of binocular vision with defocus visual acuity of 0.0 logMAR at near while maintaining distance acuity of -0.1 logMAR and with defocus visual acuity better than 0.1 logMAR across the entire visual range. Patient-reported spectacle independence was high, with 95% of trifocal subjects not wearing glasses for far and intermediate viewing and 88% for near activities. Mean patient-reported visual disturbance scores decreased in frequency, severity, and degree of bother. The Gaussian trifocal IOL with a truncated, non-apodized 3.2 mm diffractive zone presents a favorable risk-to-benefit ratio.