ESCRS - PP05.16 - Visual And Refractive Outcomes Of Monofocal Extended Depth Of Focus Intraocular Lens Compared To A Monofocal Intraocular Lens In A Prospective Randomized Clinical Trial

Visual And Refractive Outcomes Of Monofocal Extended Depth Of Focus Intraocular Lens Compared To A Monofocal Intraocular Lens In A Prospective Randomized Clinical Trial

Published 2023 - 41st Congress of the ESCRS

Reference: PP05.16 | Type: Free paper | DOI: 10.82333/2g97-8t74

Authors: Cedric Schweitzer* 1 , Tiago Monteiro 2 , Paul Rosen 3 , Cynthia Bentley 4 , Mark Packer 4 , Young So 4

1Ophthalmology,Bordeaux University Hospital,Bordeaux,France, 2Ophthalmology,Barga Hospital,Barga,Portugal, 3Ophthalmology,Oxford Eye Hospital,Oxford,United Kingdom, 4Santen Pharmaceuticals,Goleta,United States

Purpose

To compare visual, refractive and defocus curve outcomes between an extended depth of focus intraocular lens (EDOF IOL) and a monofocal IOL.

Setting

University hospital of Bordeaux (France), Braga Hospital (Portugal), Oxford Eye Hospital (United Kingdom)

Methods

Prospective multicenter participant-blinded randomized clinical trial comparing a monofocal EDOF IOL (Xact mono-EDOF ME4, Santen Pharmaceuticals)) and a monofocal aspherical IOL (ZCB00 (Johnson & Johnson vision inc.). Patients were randomly allocated in one of the two groups of IOLs (Group 1: EDOF IOL, Group 2: Monofocal IOL) with a 2:1 ratio. All patients underwent uncorrected and best corrected distance and intermediate visual acuity (UCDVA, UCIVA, BCDVA, BCIVA), defocus curve measurement as well as contrast sensitivity (CSV 1000, vectorvision), Halo&glare simulator and VF-14 quality of life questionnaire measurements. Patients were evaluated preoperatively, at one day, one week, one month, 3 months and 6 months postoperatively.

Results

62 patients (124 eyes) were randomized, 62 eyes in group 1 and 32 eyes in group 2. The mean age was 69.9+/-7.0 years. Mean refractive spherical equivalent was at -0.14+/-0.32 diopters in group 1 and 0.03+/-0.59 Diopters in group 2. At 6 months follow-up visit, UCDVA and UCIVA were at 0.02+/-0.13 and 0.07+/-0.14 LogMAR respectively in group 1, and 0.09+/-0.14 and 0.21+/-0.22 LogMAR respectively in group 2. At 6 months there was no significant difference in VF-14 quality of life questionnaire scoring, contrast sensitivity values or halos between the 2 groups.

Conclusions

As compared with a conventional monofocal IOL,
Xact mono-EDOF ME4 IOL showed good visual performances at far and intermediate distance with a depth of focus of 1 to 1.5 diopters. Photic phenomena were comparable to a monofocal IOL.