ESCRS - FP24.11 - Evaluation Of The Safety And Performance Of A Novel One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens: Results From A Prospective, Multicentre Clinical Trial

Evaluation Of The Safety And Performance Of A Novel One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens: Results From A Prospective, Multicentre Clinical Trial

Published 2023 - 41st Congress of the ESCRS

Reference: FP24.11 | Type: Free paper | DOI: 10.82333/4vb3-yx75

Authors: Paul Harasymowycz* 1 , Christoph Kraneman 2 , Sebastien Gagne 3 , Adam Muzychuk 4 , Eric Tam 2 , Baseer Khan 5 , Amandeep Rai 2 , Nima Shahi 6 , Ike Ahmed 2

1Bellevue Ophthalmology Clinics,Montreal,Canada;University of Montreal,Montreal,Canada, 2University of Toronto,Toronto,Canada, 3Institut de l'Oeil des Laurentides,Boisbriand,Canada, 4University of Calgary,Calgary,Canada, 5Clarity Eye Institue,Toronto,Canada, 6Bellevue Ophthalmology Clinics,Montreal,Canada

Purpose

To evaluate the safety and performance of the new enVista trifocal intraocular lens (MX60EFH, Bausch + Lomb) to provide improved intermediate and near visual acuity while maintaining comparable distance visual acuity relative to the one-piece monofocal comparator (enVista MX60E).

Setting

Prospective, multi-centre, randomized, masked, controlled clinical study (NCT04224155)

Methods

This is a
prospective, multicenter, randomized, masked, controlled clinical study evaluating the safety and efficacy of the enVista one-piece hydrophobic acrylic trifocal IOL in subjects with bilateral cataracts.  A total of 165 subjects were randomized across 9 Canadian centers in a 2:1 ratio to receive bilateral implantation of either the enVista trifocal IOL or enVista monofocal IOL.  Primary performance outcome measures were monocular UDVA (4m), UIVA (66cm), and UNVA (40cm) for the first implanted eye at up to 180 days after second eye IOL implantation.   Primary safety outcomes included incidence of adverse events (AEs).
Binocular CDVA defocus curves were conducted on a subset of subject for defocus powers +1.50D through -3.50D.

Results

The primary performance endpoints were met, with the trifocal IOL showing statistical non-inferiority to the monofocal IOL in monocular UDVA and statistical superiority to the monofocal IOL in monocular UNVA and UIVA (p < 0.0001). Mean ± SD monocular uncorrected VA (logMAR) in first implanted eyes in the trifocal IOL group and monofocal IOL group respectively were 0.121 ± 0.134 and 0.044 ± 0.122 for UDVA; 0.163 ± 0.125 and 0.286 ± 0.154 for UIVA, and 0.210 ± 0.129 and 0.476 ± 0.159 for UNVA.  No subjects had treatment emergent serious AEs related to the study IOL. Binocular defocus curve testing demonstrated that the trifocal IOL produces an advantage in intermediate and near vision compared to the monofocal IOL group.

Conclusions

The new enVista trifocal IOL is safe and effective at providing functional uncorrected visual acuity at distance equivalent to the enVista monofocal, with significantly better near and intermediate visual acuity.