Comparison of the visual performance of a refractive extended depth of focus intraocular
lens in an emmetropic or monovision modality

Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality

Cataract

With an expanding market of different types of intraocular lenses (IOL), spectacle
independence is a rising aim in modern cataract surgery. The procedure has in many cases
changed from a vision restoring to a presbyopia correcting approach. Although bilateral
monofocal IOL implantation, aiming for emmetropia, leads to high levels of patient
satisfaction for distance vision, spectacle dependence for reading and intermediate
vision tasks is the usual result.

The option commonly used to achieve spectacle independence at intermediate distance
(e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. These IOLs
have an extended far focus area which reaches to the intermediate distance, providing
high-quality vision over a continuous range of focus, rather than distinct foci with blur
in between. In the last years several technologies for EDOF IOLs appeared on the market.
The spectrum ranges from small aperture design, bioanalogic design, to diffractive and
non-diffractive optics. The disadvantage compared to monofocal lenses in all the
technologies mentioned is the potentially worse distance vision and contrast sensitivity
as well as dysphotopsia.

A new refractive EDOF lens segment with an extended depth of vision was introduced which
promises an increased range of functional vision and less dysphotopsias compared to
diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia
correcting alternative for people with existing corneal or macula pathologies, which
would preclude them from receiving premium lenses because of the loss of light in the
diffractive process. To increase spectacle independence for these patients, IOLs may be
used in a monovision modality, with an offset of up to 1.5dpt. This method showed good
results in the literature so far for monofocal and multifocal intraocular lenses.

Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set
for emmetropia or monovision.

120 eyes of 60 patients will be included into this study. Patients will be either
randomized in the emmetropia or the monovision group

Follow-up visits will be 1 week after each surgery and 3 months post-surgically. During
these visits, the clinical variables to be assessed will be visual acuity, stereopsis,
contrast sensitivity, and binocular defocus curves.

Emmetropic modality

Monovision modality

Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality

Corrected and uncorrected binocular visual acuity for near distance will be assessed at
40 cm using ETDRS charts

Principal Investigator

Corrected and uncorrected binocular visual acuity for distance will be assessed at 4 m
using ETDRS charts

Corrected and uncorrected binocular visual acuity for intermediate distance will be
assessed at 66 cm using ETDRS charts

Contrast sensitivity will be tested using the Optec Vision tester under mesopic and
photopic conditions with and without an additional glare source

Subjective quality of vision will be assessed using a questionnaire

Patient will receive the PureSee IOL with an emmetropic modality

Patient will receive the PureSee IOL in a monovision modality

Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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