Posters

Clinical comparison and patient satisfaction with a novel Monofocal Extended Depth of Focus IOL satisfying ISO 11979-2 optical standards for monofocal IOLs

Poster Details

First Author: M.Packer USA

Co Author(s):                        

Abstract Details

Purpose:

To investigate and compare the clinical outcomes of the Mono-EDoF IOL Model ME4 (Santen) to a traditional monofocal IOL, Tecnis Model ZCB00 (JNJ)

Setting:

Studies were conducted at three sites: 1) Department of Ophthalmology, University Hospital Pellegrin, Bordeaux, France; 2) Oxford Eye Hospital, Oxford, UK; 3) Department of Ophthalmology, Hospital of Braga, Braga, Portugal.

Methods:

Subjects presenting for cataract surgery who met all inclusion and exclusion criteria were enrolled in a prospective, randomized, multicenter study. Subjects were implanted bilaterally with either Mono-EDoF Model ME4 or Tecnis Model ZCB00. Clinical safety and effectiveness outcomes, including visual acuity outcomes (UDVA, CDVA, UIVA, DCIVA), defocus curve testing, contrast sensitivity, visual effects assessment, patient-reported outcomes and the incidence of adverse events were measured at or after 90 days postoperatively.

Results:

Both IOLs showed excellent distance visual acuity, contrast sensitivity, and visual effects that are expected from a monofocal IOL. However, Mono-EDoF Model ME4 also demonstrated good functional visual acuity in the intermediate range at 66 centimeters without demonstrating visual effects such as glare and halo. Patient satisfaction was statistically equivalent between the two IOL groups.

Conclusions:

The Mono-EDoF IOL Model ME4 provides intermediate range visual acuity and defocus performance superior to the standard monofocal IOL, while at the same time maintaining quality of vision similar to the standard monofocal IOL with minimal photic phenomena and a high rate of patient satisfaction.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company