Clinical trial NCT05194150: Performance of Two Intraocular Lenses With Extended Depth of Vision
Official title: Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Senile
Keywords: Cataract
Cataract surgery
enhanced depth of focus intraocular lens
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the capsular bag performance of two extended depth of vision (EDOF) intraocular lenses (IOLs), the Rayone EMV and the Alcon Acrysof IQ Vivity, in a mini-monovision setting

Detailed description: Spectacle independence is a rising aim in modern cataract surgery. 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 in all distances are multifocal intraocular lenses. One concept of multifocality is the trifocal lens. This lens provides good vision in three focal distances: far, intermediate, and near. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision with need for reading gasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance.

A better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. 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 disadvantage compared to monofocal lenses in all of these technologies is the potentially worse contrast sensitivity as well as dysphotopsia.

A new monofocal non-diffractive lens with an extended depth of vision (Rayone EMV) promises an increased range of functional vision and less dysphotopsias. Especially in a monovision setting, where the dominant eye is set for emmetropia and the other eye for low myopia is believe dto be a promising concept for spectacle independence.

Hence, the aim of this study is to compare a new monofocal IOL wit a non-diffractive extended depth of vision (Rayone EMV) with an already established non-diffractive EDOF IOL (Alcon Acrysof IQ Vivity) in a mini-monovision setting.

96 eyes of 48 patients will be included into this study. After randomization, each patient will either receive the Rayone EMV or the Alcon Acrysof IQ Vivity in both eyes. Follow-up visits will be 2 weeks and 3 months after surgery. During these visits a slitlamp examination, measurement of the intraocular pressure, visual acuity assessment, pupil size measurement, determination of the defocus curve, contrast sensitivity measurements, reading speed detection, and a flaremeter measurement will be performed.

Eligibility criteria: Inclusion Criteria:

* age-related bilateral cataract
* age 21 or older
* visual acuity \> 0.05
* axial length: 22.0 - 26.0 mm
* normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* written informed consent prior to surgery

Exclusion Criteria:

* active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
* relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
* corneal decompensation or corneal endothelial cell insufficiency
* previous ocular surgery or trauma
* persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
* corneal astigmatism \> 1 dpt.
* retinopathies

Primary outcomes:
measure: Visual acuity at intermediate distance
timeFrame: 24 months
Secondary outcomes:
measure: Visual acuity at far distance
timeFrame: 24 months
measure: Visual acuity at near distance
timeFrame: 24 months
measure: Visual acuity in the defocus curve
timeFrame: 24 months
measure: Halometry
timeFrame: 24 months
measure: Contrast sensitivity
timeFrame: 24 months
measure: Reading speed
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
name: Oliver Findl, MD
role: PRINCIPAL_INVESTIGATOR
References: