Single-center, Double-arm, Prospective Clinical Trial to Compare Visual Performance of Non-diffractive Extended Vision and Neutral Aspheric Monofocal Intraocular Lenses
Condition: Cataract; Presbyopia
MeSH terms: Cataract; Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the binocular distance, intermediate, and near visual
      acuity of the Alcon Vivity and Bausch & Lomb enVista IOLs.

      We hypothesize that the Alcon Vivity and Bausch & Lomb enVista IOLs will have similar
      distance, intermediate, and near visual acuity. If the null hypothesis is rejected, then the
      visual performance of the IOLs may be different.
    

Detailed description: 
      Presbyopia correcting intraocular lens (PC-IOL) technology has been available for decades.
      Lens designs have included refractive (e.g. AMO ReZoom), apodized diffractive (e.g. Alcon
      Acrysof ReSTOR/PanOptix), accommodating (B&L Crystalens), and extended depth-of-focus (e.g.
      J&J Symfony) technology. Spectacle independence is significantly higher with PC-IOLs when
      compared with that of monofocal IOLs.1,2 Despite their clear benefits, PC-IOLs are not
      without drawbacks. Any IOL that splits light to deliver distinct distance and near foci
      creates the potential for photic phenomenon, which patients may perceive as glare, haloes,
      and starbursts.3,4

      Pseudoaccommodation is defined as an increased depth-of-focus in an emmetropic eye that does
      not have the ability to change its refractive power. Spherical aberration, which may come
      from the cornea or IOL, plays an important role in pseudoaccommodation.5,6 There is a small
      body of literature that IOLs (e.g. Mini WELL, SIFI, Catalina, Italy) with highly-positive
      spherical aberration can result in significant pseudoaccommodation and lower unwanted optical
      phenomena than current multifocal IOLs.7

      The Alcon Vivity PC-IOL is a hydrophobic acrylic, non-diffractive, extended depth of focus
      IOL designed for implantation in the capsular bag following cataract extraction. The
      single-piece IOL has a 6.0 mm diameter and has a hyper-prolate profile that extends the depth
      of focus to deliver a broader range of sharp vision, with the glare and halo profile
      approaching that of a monofocal IOL.8

      The Bausch & Lomb enVista MX60E is a posterior chamber hydrophobic acrylic IOL. The
      single-piece IOL has a 6.0 mm diameter and has a neural aspheric optical profile. This
      neutral aspheric profile, combined with the cornea's natural positive spherical aberration,
      may extend the depth of focus relative to other negative aspheric hydrophobic acrylic
      monofocal IOLs on the market.

      To date, there is no existing literature comparing the visual performance and patient
      reported outcomes of the two above mentioned lens technologies; namely, one that relies on a
      non-diffractive, hyper-prolate profile and another that relies on the cornea's natural
      positive spherical aberration to provide pseudoaccommodation.

      The FDA Summary of Safety and Effectiveness on the Alcon Vivity IOL compares visual and
      patient reported outcomes of the Alcon Vivity IOL and the Alcon Acrysof SN60WF. While the
      Alcon Acrysof SN60WF and Bausch & Lomb enVista lenses are not identical, they are considered
      similar. The document reported improved intermediate vision with the Alcon Vivity over the
      SN60WF, and rates of reported visual disturbances were similar between the two devices.

      Whereas the Alcon Acrysof SN60WF has a negative aspheric optical profile, the Bausch & Lomb
      enVista has a neutral aspheric optical profile. Theoretically, the Bausch & Lomb enVista IOL
      may provide increased intermediate vision compared with the SN60WF.
    

Intervention name(s): Extended Vision IOL; Neutral Aspheric Monofocal IOL
Intervention type(s): Device; Device
Intervention description(s): Vivity IOL implantation following cataract extraction; enVista IOL implantation following cataract extraction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, double-arm, patient and assessor blinded
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: extended vision; intraocular lens; presbyopia; enVista; Vivity