Posters

A non-diffractive extended-vision intraocular lens that meets the optical and clinical criteria for extended-depth-of-focus IOLs

Poster Details

First Author: C.McCabe USA

Co Author(s):    Z. Xu   J. Lemp-Hull   D. Carson   Z. Milanovic   -. -        

Abstract Details

Purpose:

Extended depth of focus (EDF) IOLs are intended to address the disadvantages of both monofocal and multifocal IOLs by improving range of vision while maintaining high quality distance vision and a monofocal-like visual disturbance profile.  The purpose was to assess the optical and clinical performance of a new, non-diffractive extended vision IOL (Alcon DFT015) in order to demonstrate the intended EDF attributes.

Setting:

Internal optical testing and US multisite clinical trial sponsored by Alcon Research LLC, Fort Worth, TX

Methods:

Bench MTF measurements and halo images are combined with clinically measured visual acuities of study patients and patient responses to visual disturbance questionnaires to show a) DFT015 meets the minimum distance MTF requirement for monofocal IOLs from ISO 11979-2 and demonstrates non-inferior best corrected distance visual acuity (CDVA) when compared to a monofocal IOL b) DFT015 provides greater depth of focus than a monofocal IOL c) DFT015 extends 20/32 vision beyond 1.5 diopters (66 cm) d) DFT015 has a visual disturbance profile comparable to a monofocal IOL

Results:

MTF measurements for the 20/20 spatial frequency met the minimum ISO distance requirement for small aperture. MTF measurements at 20/32 spatial frequency extend vision 0.5 D greater than the monofocal control and beyond 1.5 diopters. DFT015 halo images at large aperture are identical to halo images of the monofocal control. Clinically measured monocular CDVA demonstrates non-inferiority (less than 0.1 logMAR), and the monocular defocus curve shows greater than 0.5 D extension of 20/32 vision when compared to the monofocal control and beyond 1.5 D. Patient reported outcome results show DFT015 IOL’s visual disturbance profile's comparable to the monofocal profile.

Conclusions:

Bench measurements and clinical study results demonstrate that the non-diffractive extended vision IOL meets the expectations for the EDF category by extending depth of focus beyond intermediate while maintaining distance vision that is non-inferior to an aspheric monofocal.  The non-diffractive extended vision IOL visual disturbance profile is shown to be comparable to the monofocal control and the mesopic contrast sensitivity is maintained at a high level.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a competing company, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives non-monetary benefits from a competing company, ... receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company