Performance of Two Intraocular Lenses With Extended Depth of Vision

NCT ID: NCT05194150

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2024-01-03

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.

Conditions

Cataract Senile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rayone EMV

Patient will receive the non-diffractive monofocal IOL during cataract surgery

Group Type: EXPERIMENTAL

non-diffractive monofocal IOL

Intervention Type: DEVICE

Rayone EMV

Acrysof IQ Vivity

Patient will receive the standard EDOF IOL during cataract surgery

Group Type: EXPERIMENTAL

standard EDOF IOL

Intervention Type: DEVICE

Acrysof IQ Vivity

Interventions

non-diffractive monofocal IOL

Rayone EMV

Intervention Type: DEVICE

standard EDOF IOL

Acrysof IQ Vivity

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Johannes Zeilinger, MD

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Natascha Bayer, MSc

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Facility Contacts

Johannes Zeilinger, MD

Role: primary

office@viros.at

01 91021 ext. 57564

Natascha Bayer, MSc

Role: backup

office@viros.at

01 91021 ext. 57564

Other Identifiers

Rayner Performance

Identifier Type: -

Identifier Source: org_study_id