A randomized controlled trial on the visual function after bilateral implantation of two novel Extended Depth-of-Focus intraocular lenses.

Nowadays, the most common types of intraocular lenses (IOLs) to correct aphakia
after cataract surgery consist of monofocal, multifocal or extended depth of
focus (EDOF) IOLs. Current monofocal IOLs provide one focal point which will
provide the patient with unaided vision at only one distance, which necessitate
the need of glasses to correct vision at all other distances. Multifocal IOLs
(mIOLs) provide patients with unaided vision at more than one distance, causing
less spectacle-dependency after cataract surgery. Although mIOLs offer better
unaided near vision and less spectacle dependency in comparison to monofocal
IOLs, a well-known drawback of mIOLs is the occurrence of halos and glare and
the inherent loss of contrast sensitivity because of their optical design. EDOF
IOLs offer an extended range of focus and enable the patient to have a wider
range of unaided vision in comparison to monofocal IOLs, especially from
intermediate (66 cm) to far, while mIOLs have shown better near vision in
comparison to EDOF IOLs. The intermediate vision is becoming increasingly
important in our day-to-day tasks (with computer or smartphone use).
The two EDOF-IOLs, which will be compared in this study are the Acunex® Vario
IOL and the AcrySof® IQ Vivity® IOL. So far, there are no published studies
comparing these IOLs that offer an extended range of vision at far and
intermediate distances. It is expected that bilateral implantation with the
Acunex® Vario IOL is non-inferior when compared to bilateral implantation with
the Alcon AcrySof® IQ Vivity® IOL, with regards to binocular uncorrected
intermediate visual acuity (UIVA) at 66 cm.

The primary objective of this study is to compare the binocular uncorrected
intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months
postoperatively, in a series of patients bilaterally implanted with the Acunex®
Vario IOL versus those bilaterally implanted with the Alcon AcrySof® IQ Vivity®
IOL.

The study design is a prospective monocenter randomized, double masked
controlled clinical trial.

All patients will recieve a standard cataract surgery on both eyes with the
phacoemulsification technique. One group receives bilateral implantation with
the Acunex® Vario IOL and the other group receives bilateral implantation with
the AcrySof® IQ Vivity® IOL. A total of 32 patients will be randomized into
either the Vario-group or the Vivity-group at a 1:1 ratio.

In this study, all participants will receive their cataract surgery according
to standard procedures. As with any type of intraocular surgery, there is a
possibility of complications due to anesthesia, drug reactions, and surgical
problems.
Both Alcon AcrySof® IQ Vivity® IOL or the Acunex® Vario IOLused in this study,
are CE-marked and commercially available in the countries in which the study
will be conducted.
Postoperatively, there will be one extra postoperative visit, compared to
standard cataract surgery follow-up. During the 1 month postoperative visit,
there will be two additional, short and non-contact scans performed, using the
IOLMaster and the Casia 2. All additional measurements are non-invasive. The
participants will preoperatively and 13 weeks post-operatively be asked to fill
in questionnaires (QoV-NL, Catquest-NL and the IOLSAT).
Postoperatively there may still occur residual refractive errors leading to a
suboptimal patient satisfaction. Laser-treatment or spectacles may be needed to
correct these errors. It is expected that the majority of participants will be
spectacle-indepenent after implantation of the IOL.
Photopic phenomena (e.g. halo's and glare) can occur postoperatively, but
usually these become less apparent after neuroadaptation has taken place.
Compared to multifocal IOLs, these photopic phenomena as side effects are
expected to occur at a lower rate and intensity in the EDOF IOLs, similar to
monofocal IOLs.
Both spectacle-independency and reduced rate of photopic phenomena could
significantly increase quality of life and vision-related quality of life.
Enrolled patients will receive a travel compensation (¤0,19 per km) during the
last postoperative visit. If the participant travels by public transport,
he/she will get a full refund for these costs.