CataractNCT05194657
Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
A study testing enhanced depth of focus IOL and monofocal IOL in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- enhanced depth of focus IOL and monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 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
- Cataract
- Stereopsis
- age 21 and older
- regular corneal astigmatism of up to 3.0 D
- written informed consent prior to surgery
- normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Show all 9Show fewer
- availability, willingness and sufficient cognitive awareness to comply with examination procedures
- german as mother-tongue
- calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)
Who cannot join
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
- amblyopia
- contact lenses
- irregular corneal astigmatism on corneal topography
- postoperative subjective refraction smaller/ higher than or 0.75 D
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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
Sahand Amir-Asgari, MD, 01 91021 ext. 57564, office@viros.at
Natascha Bayer, MSc, 01 91021 ext. 57564, office@viros.at
About this study
Official title: Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL
Comparison of the visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ.
Read the detailed description
With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.
Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.
To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.
Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.
A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.
Hence, the aim of this study is to assess the visual function and reading performance with an EDOF IOL (Acrysof IQ Vivity) compared to a standard monofocal IOL (Acrysof IQ).
136 eyes of 68 patients will be included into this study. According to the randomization, 34 patients will be implanted with the Acrysof IQ Vivity in both eyes and the other 34 patients will be implanted with the Acrysof IQ in both eyes. A follow-up examination will be performed at 3 months postoperative. During this visit a slitlamp examination, biometry and tomography of the eye, refraction and visual acuity assessment, an OCT examination, a retroillumination photogrypha, reading speed analysis and halometry will be performed.
- Conditions
- Cataract
- Being tested
- enhanced depth of focus IOL, monofocal IOL
- Keywords
- Cataract, Cataract surgery, ehanced 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.
enhanced depth of focus IOLDevice
Acrysof IQ Vivity, enhanced depth of focus IOL
monofocal IOLDevice
Acrysof IQ, monofocal IOL
| Study group | Role | What they receive |
|---|---|---|
| Acrysof IQ Vivity | Experimental | Patient will receive the enhanced depth of focus IOL during cataract surgery Receives: Device: enhanced depth of focus IOL |
| Acrysof IQ | Experimental | Patiet will receive the monofocal IOL during cataract surgery Receives: Device: monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
Measured: 24 months
Secondary outcomes (1)
Visual acuity
Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- 68 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
- NCT05194657
- Sponsor's protocol ID
- Vivity
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amir-Asgari S, Georgiev S, Ruiss M, Plainis S, Pilwachs C, Findl O. Comparing postoperative reading performance and visual outcomes of a non-diffractive EDOF-IOL versus a monofocal IOL: a randomized controlled eye movement study. BMC Ophthalmol. 2025 Dec 24;25(1):694. doi: 10.1186/s12886-025-04507-9.
PubMed 41444551
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
- Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL
- ClinicalTrials.gov ID
- NCT05194657
- Acronym / sponsor ID
- Vivity
- Conditions
- Cataract
- Keywords
- Cataract, Cataract surgery, ehanced depth of focus intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 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 visual function and reading performance between the Acrysof IQ Vivity IOL, an EDOF IOL, and the monofocal Acrysof IQ.
Detailed description
With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.
Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.
To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.
Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.
A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.
Hence, the aim of this study is to assess the visual function and reading performance with an EDOF IOL (Acrysof IQ Vivity) compared to a standard monofocal IOL (Acrysof IQ).
136 eyes of 68 patients will be included into this study. According to the randomization, 34 patients will be implanted with the Acrysof IQ Vivity in both eyes and the other 34 patients will be implanted with the Acrysof IQ in both eyes. A follow-up examination will be performed at 3 months postoperative. During this visit a slitlamp examination, biometry and tomography of the eye, refraction and visual acuity assessment, an OCT examination, a retroillumination photogrypha, reading speed analysis and halometry 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 |
|---|---|---|
| Acrysof IQ Vivity | Experimental | Device: enhanced depth of focus IOLPatient will receive the enhanced depth of focus IOL during cataract surgery |
| Acrysof IQ | Experimental | Device: monofocal IOLPatiet will receive the monofocal 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 (9 listed)
- Cataract
- Stereopsis
- age 21 and older
- regular corneal astigmatism of up to 3.0 D
- written informed consent prior to surgery
Key exclusion criteria (6 listed)
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
- amblyopia
- contact lenses
- irregular corneal astigmatism on corneal topography
- postoperative subjective refraction smaller/ higher than or 0.75 D
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 |
|---|---|---|
| enhanced depth of focus IOLAcrysof IQ Vivity, enhanced depth of focus IOL | Device | Acrysof IQ Vivity |
| monofocal IOLAcrysof IQ, monofocal IOL | Device | Acrysof IQ |
Primary outcome
Reading speed
Time frame: 24 months
reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
1 secondary outcome
Visual acuity
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.
- Derived from this study: PubMed 41444551Amir-Asgari S, Georgiev S, Ruiss M, Plainis S, Pilwachs C, Findl O. Comparing postoperative reading performance and visual outcomes of a non-diffractive EDOF-IOL versus a monofocal IOL: a randomized controlled eye movement study. BMC Ophthalmol. 2025 Dec 24;25(1):694. doi: 10.1186/s12886-025-04507-9.
- 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 enhanced depth of focus IOL and monofocal IOL in people with Cataract, 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 9 inclusion and 6 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 Sahand Amir-Asgari, 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?
Reading speed (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194657, which also lists 1 linked publication.
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.