Clinical outcomes of a novel monofocal extended-depth-of-focus intraocular lens

Session Details

Session Title: Extended-Depth-Of-Focus IOLs I

Session Date/Time: Sunday 15/09/2019 | 14:00-16:00

Paper Time: 14:06

Venue: Free Paper Forum: Podium 1

First Author: : M.Packer USA

Co Author(s): :                                 

Abstract Details

Purpose:

To investigate the clinical outcomes of the Mono-EDoF IOL Model ME4 (Advanced Vision Science, Santen, Inc., Goleta, California), a novel monofocal extended depth of focus IOL which demonstrates a single broadened modulation transfer function peak, meets ISO 11979-2 monofocal optical standards and is designed to provide optimal quality distance vision while improving intermediate range visual acuity.

Setting:

Studies were conducted at two sites: 1) Augenärzte Gerl, Kretz & Kollegen, Am Schlossgraben 13, 48683 Ahaus, Germany; 2) Department of Ophthalmology, University of Heidelberg, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.

Methods:

Subjects presenting for cataract surgery who met all inclusion and exclusion criteria were enrolled in one of two prospective, interventional, open-label studies. Subjects were implanted unilaterally or bilaterally with Mono-EDoF IOL Model ME4. Clinical safety and effectiveness outcomes, including uncorrected and distance-corrected intermediate range vision at 50, 60 and 70 centimeters, defocus curve testing, contrast sensitivity, visual effects assessment, patient-reported outcomes and the incidence of adverse events were measured at or after 45 days postoperatively.

Results:

Forty-five eyes of 23 subjects, mean age 71  8 years, were enrolled. Postoperatively, mean CDVA and UDVA improved to logMAR -0.04  0.07 and logMAR 0.09  0.14. Mean MRSE and cylinder measured -0.17  0.37 D and -0.40  0.37 D. Binocular UIVA at 50, 60 and 70 centimeters measured logMAR 0.24  0.12, 0.17  0.10 and 0.08  0.12. Defocus curve testing demonstrated 1.37 D monocular and 1.75 D binocular depths of focus at logMAR 0.3. Contrast sensitivity with and without glare was in the range expected for an aspheric monofocal IOL. Visual effects were minimal.

Conclusions:

The Mono-EDoF IOL Model ME4 provides intermediate range visual acuity and defocus performance superior to the results expected for a standard monofocal IOL, while at the same time maintaining quality of vision similar to the results expected for a standard monofocal IOL and superior to the results expected for a conventional multifocal or extended depth of focus IOL. The Mono-EDoF IOL Model ME4 represents an exciting new modality for the treatment of pseudophakic presbyopia.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company