ESCRS - FP17.09 - Prospective, Randomized, Multicenter Clinical Evaluation Comparing A Monofocal Enhanced Depth Of Focus Intra Ocular Lens With A Monofocal Intra Ocular Lens

Prospective, Randomized, Multicenter Clinical Evaluation Comparing A Monofocal Enhanced Depth Of Focus Intra Ocular Lens With A Monofocal Intra Ocular Lens

Published 2023 - 41st Congress of the ESCRS

Reference: FP17.09 | Type: Free paper | DOI: 10.82333/2j6h-v778

Authors: Mark Packer* 1

1Packer Research Associates,Boulder,United States

Purpose

To investigate the safety and effectiveness of a monofocal enhanced depth of focus intraocular lens (xact Mono-EDoF IOL ME4, Santen Pharmaceuticals) when compared to a standard monofocal intraocular lens (Tecnis Monofocal ZCB00, Johnson & Johnson Vision).   

Setting

Multicenter clinical investigation conducted at 3 sites (Servico de Oftalmologia, Hospital de Braga, Braga, Portugal; Department of Ophthalmology, University Hospital Pellegrin, Bordeaux, France; Oxford Eye Hospital, Oxford, UK). 

Methods

This prospective, randomized, comparative study enrolled subjects in a 2:1 ratio with bilateral implantation of either the Mono-EDoF IOL Model ME4 or the Tecnis Monofocal ZCB00.  The ME4 is a hydrophobic acrylic glistening-free single piece IOL with a biconvex aspheric EDoF diffractive optical design.  Key eligibility criteria included expected post-operative refractive astigmatism of ≤ 1.0 D and absence of significant ocular pathology other than cataract. Follow up visits were conducted at 1 day, 1 week, 1 month, 3 months and 6 months. Assessments included UCDVA, BCDVA, UCIVA (66 cm), DCIVA (66 cm), defocus curves, contrast sensitivity (CSV-1000, VECTORVISION), Halo&Glare Simulator and Quality of Life Questionnaire (VF-14 QOL).  
 

Results

124 eyes of 62 patients (45 female, 17 male) were implanted.  Mean age was 69.9 ± 7.0 years (52 - 84).  Analysis includes 32 eyes at 3 months and 20 eyes at 6 months in the Tecnis ZCB00 group and 62 eyes at 3 months and 46 eyes at 6 months in the Mono-EDOF ME4 group. Mean MRSE and cylinder at 6 months measured 0.03 ± 0.59 D and -0.26 ± 0.79D in the Tecnis group and -0.14 ± 0.32 D and-0.25D ± 0.59D in the ME4 group.  Mean monocular and binocular UCDVA measured logMAR 0.09 ± 0.14 and -0.02 ± 0.11 in the Tecnis group and 0.02 ± 0.13 and -0.04 ± 0.10 in the ME4 group.  UCIVA and DCIVA measurements indicated approximately 1 line better acuity in the ME4 group.  Monocular and binocular defocus curve testing indicated 1.0 and 1.5 D depth of focus.

Conclusions

The Mono-EDoF ME4 IOL demonstrates similar distance and one line better intermediate visual performance compared to the Tecnis ZCB00 Monofocal IOL.  The ME4 defocus curves are typical for an EDoF IOL.  There was high patient satisfaction and virtually no differences in Quality of Life, contrast sensitivity and halo and glare between the two groups.  Study results indicate that the ME4 IOL is a premium monofocal IOL with significant benefits for intermediate vision and no additional risks compared to a standard monofocal IOL.