Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rayone EMV | Experimental | Patient will receive the non-diffractive monofocal IOL during cataract surgery |
|
| Acrysof IQ Vivity | Experimental | Patient will receive the standard EDOF IOL during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-diffractive monofocal IOL | Device | Rayone EMV |
| |
| standard EDOF IOL |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity at intermediate distance | The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity at far distance | The visual acuity at the far distance will be measured using ETDRS charts at a distance of 4 metres and compared between the two different IOLs | 24 months |
| Visual acuity at near distance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johannes Zeilinger, MD | Contact | 01 91021 | 57564 | office@viros.at |
| Natascha Bayer, MSc | Contact | 01 91021 | 57564 | office@viros.at |
| Name | Affiliation | Role |
|---|---|---|
| Oliver Findl, MD | Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna | Recruiting | Vienna | 1140 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Acrysof IQ Vivity |
|
The visual acuity at the near distance will be measured using ETDRS charts at a distance of 40 centimetres and compared between the two different IOLs
| 24 months |
| Visual acuity in the defocus curve | The visual acuity in the defocus curve will be measured using ETDRS charts at 4 metres with the patient wearing glasses in the power range of -3.5 to +1.0 diopters (presented in 0.5 dioptre steps) and will be compared between the two IOLs | 24 months |
| Halometry | The size of the halos depicted in degrees will be assessed using the aston halometer and will be compared between the two IOLs | 24 months |
| Contrast sensitivity | Contast sensitvity will be measured using the Optec Vision tester and will be compared between the two IOLs | 24 months |
| Reading speed | Reading speed will be assessed with teh Salzburg Reading Desk and will be compared between the two different IOLs | 24 months |