Cataract SenileNCT05194150
Performance of Two Intraocular Lenses With Extended Depth of Vision
A study testing non-diffractive monofocal IOL and standard EDOF IOL in people with Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- non-diffractive monofocal IOL and standard EDOF IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 3 Jan 2022to 3 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
Johannes Zeilinger, MD, 01 91021 ext. 57564, office@viros.at
Natascha Bayer, MSc, 01 91021 ext. 57564, office@viros.at
About this study
Official title: Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
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
Read the 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
- Being tested
- non-diffractive monofocal IOL, standard EDOF IOL
- Keywords
- Cataract, Cataract surgery, enhanced depth of focus intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-diffractive monofocal IOLDevice
Rayone EMV
standard EDOF IOLDevice
Acrysof IQ Vivity
| Study group | Role | What they receive |
|---|---|---|
| Rayone EMV | Experimental | Patient will receive the non-diffractive monofocal IOL during cataract surgery Receives: Device: non-diffractive monofocal IOL |
| Acrysof IQ Vivity | Experimental | Patient will receive the standard EDOF IOL during cataract surgery Receives: Device: standard EDOF IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (6)
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
Measured: 24 months
Visual acuity at near distance
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
Measured: 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
Measured: 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
Measured: 24 months
Contrast sensitivity
Contast sensitvity will be measured using the Optec Vision tester and will be compared between the two IOLs
Measured: 24 months
Reading speed
Reading speed will be assessed with teh Salzburg Reading Desk and will be compared between the two different IOLs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start3 Jan 2022
- Primary completion3 Jan 2023 (estimated)
- Study completion3 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194150
- Sponsor's protocol ID
- Rayner Performance
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
- ClinicalTrials.gov ID
- NCT05194150
- Acronym / sponsor ID
- Rayner Performance
- Conditions
- Cataract Senile
- Keywords
- Cataract, Cataract surgery, enhanced depth of focus intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 3 Jan 2024 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rayone EMV | Experimental | Device: non-diffractive monofocal IOLPatient will receive the non-diffractive monofocal IOL during cataract surgery |
| Acrysof IQ Vivity | Experimental | Device: standard EDOF IOLPatient will receive the standard EDOF IOL during cataract surgery |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-diffractive monofocal IOLRayone EMV | Device | Rayone EMV |
| standard EDOF IOLAcrysof IQ Vivity | Device | Acrysof IQ Vivity |
Primary outcome
Visual acuity at intermediate distance
Time frame: 24 months
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
6 secondary outcomes
Visual acuity at far distance
Time frame: 24 months
Visual acuity at near distance
Time frame: 24 months
Visual acuity in the defocus curve
Time frame: 24 months
Halometry
Time frame: 24 months
Contrast sensitivity
Time frame: 24 months
Reading speed
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-diffractive monofocal IOL and standard EDOF IOL in people with Cataract Senile, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Zeilinger, MD (01 91021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity at intermediate distance (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.