Evaluation of the Safety and Performance of a Novel One‐Piece Hydrophobic Acrylic Trifocal Intraocular Lens: Results from a Prospective, Multicentre Clinical Trial

Authors: Paul Harasymowycz, Christoph Kranemann, Sebastien Gagne, Adam Muzychuk, Eric Tam, Baseer Khan, Amandeep Rai, Nima Shahi, Ike Ahmed.  

Author Disclosures:    P. Harasymowycz:   Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Alcon, Bausch+Lomb, Zeiss, JandJ Vision,Glaukos, Thea, Labtician, Salient, Aequus.  C. Kranemann:   Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Bausch+Lomb.  S. Gagne:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Alcon (R) Allergan (C, R) Bayer (R) B+L (R) Clearside Biomedical (R)Glaukos (C, R) Ivantis (now Alcon)iStar (R) J&J (C, R)MicrOptx (R)Novartis (R)ROCHE (R) PowerVision (R) Sandoz (C). Any direct financial payments including receipt of honoraria; Description of relationship(s); C: consulting fees;  R: research grant/support.  A. Muzychuk:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Alcon, Bausch+Lomb. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Labtician, Bausch+Lomb. Funded grants or clinical trials; Name of for-profit or not-for-profit organization(s); Bausch+Lomb.  E. Tam:  None.  B. Khan:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Bausch+Lomb, Zeiss. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Stroma, Ceyeber.  A. Rai:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Alcon, Bausch+Lomb. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Alcon.  N. Shahi:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Novartis, Bausch+Lomb, Thea. Membership on advisory boards or speakers’ bureaus; Name of for-profit or not-for-profit organization(s); Novartis, Thea.  I. Ahmed:   Any direct financial payments including receipt of honoraria; Name of for-profit or not-for-profit organization(s); Aequus: (C) Ace Vision: (C) Aerie Pharmaceuticals: (C)(R) Akorn: (C) Alcon: (C)(S)(R) Allergan: (C)(S)(R) Aquea Health, Inc: (C) ArcScan: (C) Avellino Lab U(S)A, Inc: (C) Avisi: (C) Bausch Health: (C), Beaver Visitec: (C) Beyeonics: (C) Bionode: (C) (R) Carl Zeiss Meditec: (C)(S) Centricity Vision, Inc: (C) CorNeat Vision: (C) custom Surgical: (C) Elios Vision: (C) ElutiMed: (C) Equinox: (C), eyeFlow, Inc: (C) Exhaura Limited: (C) Genentech: (C) Glaukos: (C)(R) Gore: (C) Heine: (C)(S) Heru: (C) Iantrek: (C) Inject Sense: (C) Iridex: (C) iCare: (R) iStar: (C )Ivantis: (C)(R), Johnson & Johnson Vision: (C)(S)(R) Labtician Thea: (C) LayerBio: (C) Leica Microsystems: (C) Life Long Vision: (C) Long Bridge Medical, Inc: (C) MicroOptx: (C) MST Surgical: (C)(S) Myra Vision: (C), New World Medical: (C)(R)NovaEye: (C) Ocular Instruments: (C) Ocular Therapeutix: (C) Oculo: (C) Oculus Surgical: (C) Omega Ophthalmics: (C) PolyActiva: (C) PulseMedica: (C), Radiance Therapeutics, Inc: (C) Ripple Therapeutics: (C) Sanoculis: (C) Santen: (C)(R) Shifamed, LLC: (C) Sight Sciences: (C) Smartlens, Inc: (C) Stroma: (C) Thea Pharma: (C) ViaLase: (C), Visus Therapeutics: (C) Vizzario: (C) VSY Biotechnology: (C) Zilia, Inc: (C). Any direct financial payments including receipt of honoraria; Description of relationship(s); C: consulting fees; S: speakers honorarium; R: research grant/support.

Abstract Body: 

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). 

Study Design: Prospective, multi‐centre, randomized, masked, controlled clinical study (NCT04224155) 

Methods: A total of 165 subjects with clinically significant cataract and a CDVA of 20/40 or worse in at least one eye were included in the study. Subjects with significant ocular pathologies and/or preoperative corneal astigmatism greater than 1.0 D were excluded from the study. Written informed consent was obtained from each study subject prior to performing any study‐specific procedures. All subjects were randomized 2:1 to receive either the enVista trifocal or monofocal control IOL bilaterally across 9 Canadian centres and were followed up to 120‐180 days postoperatively. Primary performance endpoint was photopic uncorrected distance (4 m), intermediate (66 cm), and near (40 cm) visual acuity of the first implanted eye and primary safety endpoint was the incidence of adverse events up to the final postoperative visit.

Results: 111 subjects received the enVista MX60EFH trifocal IOL and 54 subjects received the enVista MX60E monofocal IOL. No significant differences in demographic and pre‐op characteristics were observed between both treatment groups. Both performance and safety endpoints were met. The trifocal IOL showed 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 experienced treatment emergent serious adverse events related to the study device.

Conclusions: The new enVista trifocal IOL is safe and effective at providing functional uncorrected visual acuity at distance equivalent